1
Abstract of the thesis entitled
An Evidenced-based guideline of tracheostomy care using tracheal suctioning and
humidification on pulmonary protection for patients after total laryngectomy
Submitted by
SUN KA YAN
For the Degree of Master of Nursing
At the University of Hong Kong
In August 2014
The number of patients diagnosed with naso-laryngeal cancer has increased
dramatically in the past decades (Hong Kong Cancer Registry, 2012). The opening of
tracheostomy is always the first line treatment plan for patient with total laryngectomy
done. This surgical- incisional opening switch the respiratory process to another mode
which requires the patients and their significant others to pay additional care for
pulmonary protection. Maintaining adequate moisture is a key element to stay the
tracheostomy healthy. Traditionally, free flow steam vaporizing machine were applied
2
which associated with different pulmonary complications, for example, excessive
tracheal secretion, numerous forceful cough and negative psychological influences.
Recent researches documented that a device named as “Heat Moisture Exchanger”
(HME) could relieve these undesirable respiratory symptoms on tracheostomy
patients in a greater extent and in turn promote a better quality of life to them. Lower
the occurrence of pulmonary complaints and facilitate better rehabilitation process can
foster early discharge and recovery stage. Therefore, this translational research –the
use of HME to tracheostomy immediately after operation aims to evaluate the current
evidence on the effects of adopting a specific tracheostomy care program on HME use,
to formulate an evidence- based guideline, assess its transferability and feasibility and
ultimately to develop an implementation and evaluation plan.
Five related literature were retrieved from three electronic bibliographical databases.
Critical appraisal had been done to ensure the quality and validity of the selected
articles. Clinical guideline was then developed. The implementation potential was
achieved by ensuring the patients’ characteristic and clinical environment stay similar
to the proposed settings. It is discovered that the transferability was high to the local
designated setting and it is feasible to operate this innovation in long run. Limited
resources are required to set up this innovation as most of the assessment tools are
3
readily available in general ward setting. The major investment is only the expense
spent on purchasing the HME. The implementation plan was then established after gaining the consensus from the
stakeholders; a pilot study will be launched to tackle the barriers before full-scale
implementation of the program.
Evaluation plan was done afterwards to examine the effectiveness of the innovation.
Findings can be used to make adjustments of the guideline to make better outcomes.
This HME tracheostomy care innovation is worthy to adopt in clinical setting as it can
bring benefits to patients, staff and hospital in various aspects.
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An Evidenced-based guideline of tracheostomy care
using tracheal suctioning and humidification on
pulmonary protection for patients after total
laryngectomy
by
Sun Ka Yan
R.N., B.Nurs. H.K.U.
A thesis submitted in partial fulfillment of the requirement for
The degree of Master of Nursing
at the University of Hong Kong
August 2014
5
Declaration I declare that this dissertation represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a thesis,
dissertation or report submitted to this University or to any other institution for a
degree, diploma or other qualifications.
Signed:
SUN KA YAN
6
Acknowledgements I would like to show my sincere gratitude to my supervisor Dr. William Li and Ms.
Joyce Chung for their patient guidance and way long support for the completion of
my dissertation in these 2 years. Without their insightful comments and suggestions,
this dissertation cannot be completed. I would like to say “Thank You” to them.
I would also like to thank my classmates and group-mates during the 2 year Master
Program for their support. I have had a fruitful and cheerful time in my study. More
than that, thanks to my family for their warm encouragement and support in my life,
making it goes smooth and delighted.
7
Table of Contents
Chapter 1 – Introduction ………………………………………………………….11
1.1 Background ......................................................................................................... 11
1.2 Affirming the need .............................................................................................. 13
1.3 Objectives and significance ................................................................................ 13
Chapter 2 – Critical Appraisal ……………………………………………………20
2.1 Search and appraisal strategies ........................................................................... 20
2.1.1 Identification of studies ..........................................................................20
2.1.2 Inclusion criteria .................................................................................... 20
2.1.3 Exclusion criteria ................................................................................... 20
2.1.4 Data extraction ....................................................................................... 20
2.1.5 Appraisal strategy ................................................................................... 22
2.2 Results ................................................................................................................. 23
2.2.1 Search results ......................................................................................... 23
2.2.2 Study characteristics .............................................................................. 23
2.2.3 Quality appraisal .................................................................................... 24
2.3 Summary and synthesis .................................................................................…...28
2.3.1 Pulmonary Symptoms…………………………………………………………28
2.3.2 Psychological Symptoms………………………………………………………28
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2.3.3 Post operation immediate use of HME………………………………….........29
2.3.4 Frequency of HME use…………………………………………………. ....... 29 2.3.5 Conclusion……………………………………………………………………30
Chapter 3- Translation and Application…………………………………………31
3.1 Implementation potential
3.1.1 Transferability of the findings……………………………………………..31
3.1.2 Feasibility………………………………………………………………….34
3.1.3 Cost-benefit ratio of the innovation……………………………………….36
3.2 Evidence-based protocol………………………………………………………...39
Chapter 4- Implementation Plan………………………………………………….44
4.1 Communication Plan…………………………………………………………….44
4.1.2 Communication process and the implementation strategies……………….45
4.2 Pilot testing plan……………………………………………………………..48
4.2.1 Subject recruitment strategies……………………………………………...48
4.2.2 The guideline………………………………………………………………49
4.2.3 Logistics……………………………………………………………………50
4.2.4 Methods for collecting data………………………………………………..50
4.2.5 Methods for evaluating effectiveness……………………………………...50 Chapter 5- Evaluation Plan………………………………………………………..52
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5.1 Identifying outcomes……………………………………………………………52
5.1.2 Data measurement………………………………………………………….54
5.1.3 Nature and number of clients to be involved………………………………55
5.1.4 Data analysis………………………………………………………………..57
5.1.5 Determination of the protocol effectiveness……………………………….57 Conclusion………………………………………………………………………… 59
Appendix……………………………………………………………………………60
Appendix 1--Searching Process…………………………………………………………………...60
Appendix 2--Table of Evidence……………………………………………………………………61
Appendix 3--Critical appraisal for the retrieved RCTs by SIGN 2013……………………………66
Appendix 4--Level of Evidence……………………………………………………………………70
Appendix 5--Cost of staff for setting up the innovation……………………………………………71
Appendix 6 --Staff satisfaction questionnaire………………………………………………………72
Appendix 7--Patient Satisfaction questionnaire…………………………………………………….74
Appendix 8—Satisfaction Questionnaire of the training session…………………………….
......................................................................................................................................................... 76
Appendix 9--Gantt chart for implementation of HME humidification to tracheostomy………….77
Reference…………………………………………………………………………...78
10
Abbreviation APN Advanced Practice Nurse
COS Chief of Service
DOM Department Operation Manager
HA Hospital Authority
HK Hong Kong
H&N Head and Neck
HME Heat Moisture Exchanger
ICU Intensive Care Unit
NPC Nasopharyngeal Cancer
RCT Randomized Control Trail
VRE Vancomycin Resistant Enterococci
WM Ward Manager
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Chapter 1:
Introduction 1.1 Background:
Tracheostomy is a surgical opening in the trachea to facilitate breathing for
patients to relieve upper respiratory tract obstruction or for cases with prolonged
mechanical ventilation. According to Akenroye et al. (2013), tracheostomy could
be a short term or a long term tracheostomy, knowing as temporary and permanent
tracheostomy respectively. Temporary tracheostomy will only be inserted in place
from few days to few weeks and when the respiratory obstruction subsides, it will
then be removed. The removal of the temporary tracheostomy will heal up
spontaneously by air tight dressing or surgical suturing. On the other hand, for
permanent tracheostomy, it remains on the patient for his whole life due to
irreversible damage to the laryngeal respiratory functions like cancer of larynx,
radiation of upper airway or post operation complications of thyroidectomy like
laryngeal nerve paralysis to the patients. There are indeed numerous new
challenges they need to encounter to adapt to their new life. During hospitalization,
tracheostomy care can be performed by health care professionals. However, in the
long run after discharge, patients with permanent tracheostomy need to manage
the tracheostomy care themselves and its related lifelong complications, which is a
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challenging task. Insufficient management skills and caring deficit may cause
life-threatening consequences. The professional tracheostomy teaching skill from
nurses during their hospitalization is important for their long-going post-operative
care. In view of this, tracheostomy care and education to patients with permanent
tracheostomy is crucial and it is essential for health sectors to set up protocols and
guidelines for health care professionals in providing optimal and standard care to
patients having tracheostomies to minimize their opportunities of suffering from
complications and facilitate early and safe discharge from hospital to home.
The loss of the function of the upper respiratory tractdue to the permanent
tracheostomy will preclude the natural normal humidification and filtration
process of inhaled air by the nose and pharynx taking place in a healthy person
(Akenroye et al., 2012). The entrance of unconditioned inhaled air will cause
colder and dryer air to the trachea and bronchi, inducing various pulmonary
problems like excessive phlegm production, involuntary coughing and forceful
expectoration (Merol et al, 2012). These undesirable symptoms have negative
impact on patients’ quality of life for rehabilitation. Therefore, humidification is a
critical component for the pulmonary protection for laryngectomees. In the far
past decades, external humidifier was directly applied to moisturize and warm the
air for the patients with total laryngectomy done (Merol et al, 2012). However,
13
due to its poor compliance rate because of the uncomfortable noise production and
the bedridden disadvantage for the patient to stay remain near the humidifying
system. As a result, the popularity of the use of external humidification dropped.
To overcome the discomfort and to improve compliance, heat and moisture
exchanger (HME) is introduced for tracheostomy patients. HME is a passive
humidifier to trap the heat and moisture generated by the patient’s self-exhaled air
and thus to restore the water contentfor the subsequent inhaled air (Ackerstaff et al.
2003).
1.2 Affirming needs
It is not rare for nurses to take care of patients with tracheostomy in workplace.
Due to the change in health care setting and the economic pressure, the length of
stay in intensive care unit (ICU) for tracheostomy care is shortened. In this way, it
implies an increased workload in general ward setting to take care patients with
tracheostomies (Paul, 2010). According to the literature review conducted by Paul,
2010, the nurses in general setting are lacking experience and knowledge in
providing care to tracheostomized patient. The review done by Paul., 2010 also
highlighted that the general nurses expressed they were experiencing stress,
anxiety and fear in caring patients with long term tracheostomies. Although the
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suggested practice of tracheostomy care guidelines was documented in several
researches, the implementation and application compliance was limited. The
current care and management in real clinical setting tends to be based on ward
routine with staff subjective opinion which resulting in staff making individual
judgments. This probably leads to the discrepancies in providing safe and
effective care for the laryngectomees. Take our local setting in Hong Kong
hospital into account, the medical practitioners and nurses obviously recognized
the needs and importance of supplying additional humidity to the tracheostomized
patient to compensate the loss of warming and humidifying inhaled air abilities.
There are guidelines for nursing staff to read as reference when providing
tracheostomy care to patients now through Hong Kong in Hospital Authority
Intranet. However, the content of the guideline was neither written clearly nor in
details. For example, the pre-printed care plan for tracheostomy care only
mentioned the term “humidification” for the nurses to comply with providing care
to patients with tracheostomies. It did not specified the caring details like the
standard humidification devices to use with evidence supporting the guideline,
making it not reliable and convincing to support the underlying action. Also, the
current guidelines have not been reviewed for 5-10 years by the hospital authority.
Medical technology getting more advanced with breakthrough and innovations
15
happening nearly every day, it is important to stay alert and catch up with the
latest worldwide tracheostomy care trend and provide effective care to our clients
in order to maintain the top medical reputation in Hong Kong. In addition, there
are variations in current tracheostomy care practices among various hospital
clusters or even different departments within the same hospital in Hong Kong. For
example, the use of humidification is not standardized and no evidence- based
researchs have been conducted and available yet. Some of the settings like my
current workplace, ENT specialty ward, promote the use of free flow steam
humidification to keep the moisture of the tracheastomy whereas other settings
prefer the use of HME or T-piece to trap the moisture generated from patient
himself as well as concerning of the infection control issues. Consequently, it is
uncertain which method is the most appropriate method to moisturize and filter
the inhaled air for the tracheostomized patient and in order to preserve the
pulmonary function. The application of HME is a rather novel method when
compared with other current devices. Several literatures concluded that the use of
HME was beneficial to improve the clients’ medical, social and psychological
aspects whereas some research alsorevealed that there weresome drawbacks of
HME like its effect under cold climate, the occurrence of skin allergy or the sense
of breathing occlusion. The present tracheostomy care management mainly
16
depends on individual ward’s conventional practices and the experience gained
through repeating the procedure and reviewing the results by the ward themselves.
Limited official researches have been conducted and published. It is indeed unsafe
and risky no matter for the staff and the patient to perform and to receive the
procedure without evidence-based guidelines in guiding the tracheostomy care. It
is foreseeable that more tracheostomized patient will be discharged home with the
self- tracheostomy care under contemporary medical setting. In view of this,
there are clear and urgent affirming needs to examine an optimal humidification
method to tracheostomy. One of the key components to establish healthy
trachostoma is to set up an evidence-based and effective guideline to upgrade the
care to tracheostomy. By doing so, the safety of staff can be protected and the
patient can acquire consistent self-tracheostomy care knowledge which eventually
promote early and safe discharge in long run.
1.3 Significance and Objectives
The incidence and occurrence of laryngeal cancers with the opening of
tracheostoma to support breathing is not rare worldwide. Each year, more than
7000 patients receive tracheostomies in Australia and New Zealand (Garrubba et
al, 2009) and there are 2376 reported cases of laryngeal cancer in United Kingdom
per year (Jones et al, 2003). Locally in Hong Kong, around 600-700 cases were
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newly diagnosed with nasolaryngeal cancer annually (Hong Kong Cancer Registry,
2010) which revealed an increasing trend for patients with head and neck cancer.
Some of them are potential candidates who will undergo surgery for opening
permanent tracheostomy. However, tracheostomy care is not standardized among
different clusters in Hong Kong and no evidence based guideline is available for
health care providers to follow when providing related services. According to
several literature findings, the presence of traceostomy to patients brought them
negative impact which will diminish their quality of life and the physical
constraints like problems of adjusting to social environment and aphonia (Gilony
et al, 2005). The medical or surgical complications caused by tracheostomies are
another alarming signal that draws attention worldwide for better management of
tracheostomy care. Nearly all patients having tracheostomies suffer from at least
one of the complications like excessive mucus secretion, stoma infection and
polyp formation around the stoma during their life (Akenroye, 2012). The
occurrences of these complications may drive them living under anxious and
stressful lifestyle.
These complications can be fatal in some cases and should not be underestimated.
Some of these complications are actually preventable or can be managed in earlier
stage through more comprehensive tracheostomy care. The recent incident took
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place in Kowloon Hospital in Hong Kong in 2011 was about a male patient with
advanced cancer of hypopharynx with permanent tracheostomy. He passed away
because his tracheostomy was accidentally covered with gauze inappropriately
with all 4 edges appended. This incident revealed that the nursing staff was still
lack of experience in handling tracheotomy case and there is still room for
improvement in this medical area. Further education and training is needed to
increase staff’s awareness on trachetsomy care. Literature suggested that
establishing an early, organized and systematic protocol and discharge plan for
tracheostomy patients can facilitate health care professionals to offer optimal and
appropriate care to patients (Bowers et al, 2007). This can promote tracheostomy
self-care technique through establishing assessment check lists with critical points
highlighted to estimate their learning progress and ultimately can achieve the
success of safe discharge and reduce readmission to hospital.
Objectives: Based on the clinical situation mentioned above, the objectives of this dissertation are:
1) Togather the evidence of the effect of the current humidification devices on the
pulmonary protection to patients who have undergone total laryngectomy
2) To establish an evidence based guideline of tracheostomy care with the use of
HME as the humidification application for the tracheostomized patients
19
3) To assess the implementation of the evidenced based tracheostomy care guideline
with HME to improve the pulmonary function of the laryngectomeesand
determine the potential barrier encountered during the implementation process
4) To assess the feasibility and the transferability of the tracheostomy care
innovation
5) To set up the implementation and evaluation plan to assess the effectiveness of the
innovation
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Chapter 2:
Critical Appraisal
2.1 Search and appraisal Strategies 2.1.1 Identification of the studies
To search for the literature studies relating to the humidification devices for the
clients with total laryngectomy done. The searching process began from March, 08,
2013 to August 20, 2013. Three electronic searching databases including Pubmed,
Proquest and First Search were used. The searching keywords are “humidification”,
“humidifier”, “heat and moisture exchanger”, “laryngectomy”, “tracheostomy,
“pulmonary function” and “randomized control trail”. By performing the advanced
search for the individual database, 19 citations were found from Pubmed; 20
citations from Proquest and 116 citations from British Nursing Index. Limits were
applied to full text available only. All the duplicated journals were not double-
counted. After screening the related citations, some articles relating to the
comparison of two different models of HME and about the voice phonation with
the HME were discarded. Further search limitation is done by reviewing the
abstracts, 4 randomized control trails and 1 cohort study journals were most
relevant to the area of interest and were selected. The detailsare listed in the
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appendix 1. 2.1.2 Inclusion Criteria
To screen and look for the most relevant studies from the databases, criteria were set
up to extract the appropriate papers. The inclusive target group criteria would be
adults with age equal to or older than 18 of both genders with total larynghectomy
done with the presence of tracheostomy. The intervention would be the application of
HME as the humidification method. Other inclusion criteria are publication either in
Chinese or English due to language barrier.
2.1.3 Exclusion Criteria
Studies would be excluded when the target group is 1) with temporary tracheostomy;
2) not solely with laryngeal cancer but with metastatic or recurrence in other parts of
the body; 3) tracheostomy with pharyngeal fistula and stenosis noted before the
research started
2.1.4 Data Extraction
The content of the 5 selected articles were summarized in the table of evidence
(Appendix 2). The author, published year, study type, patient characteristics, sample
sizes, intervention and comparison, length of follow up, outcome measurement and
22
the results were included and analyzed. The intervention of 4 selected studies focus on
the pulmonary effect with and without the use of HME. Only 1 RCT compared the
effect on pulmonary symptoms with HME VS external humidifier. The measured
outcomes were similar in all 5 selected articles. They are the frequency of forceful
coughing and stoma cleansing, experience of shortness of breath, compliance rate,
chest infection rate. 3 articles compared the psychological wellbeing symptoms as
well including the anxiety and depression symptoms and sleeping quality in addition
to the physiological symptoms.
2.1.5 Appraisal Strategies
The methodology used to grade the standard of the articles selected is the Scottish
Intercollegiate Guideline Network (SIGN, Feb, 2013). It is a checklist set up to
appraise the quality of the RCT journal articles critically. It assesses the quality of the
article by considering several listed areas in the appendix 3:
1) Study Question 2) Randomization involvement
3) Concealment method
4) Binding allocation
5) Similarity of the characteristics between the intervention and control groups
23
before the study 6) The quality of the outcome measurement
7) Drop-out rate
8) Intention- to- treat analysis
9) Multi- centered involvement
2.2 Result 2.2.1 Search Results
After the advanced search from 3 databases, 115 citations were retrieved, 19 from
Pubmed; 20 from Proquest and 116 from British Nursing Index. The duplicated
studies were eliminated. Screening of the articles topic and the abstracts, 3 RCTs
journals satisfied the inclusion and exclusion criteria and the intervention investigated.
The reference list of the selected 3 articles were reviewed carefully to look for
potentially relevant studies, 2 studies, including 1 RCT and 1 cohort study, can also
fulfill the area of interest of this dissertation and the full text of these 2 journals were
retrieved. The content of the 5 selected studies were analyzed and summarized.
2.2.2 Study characteristic
All the 5 studies were conducted in western countries. No local or Asia related articles
24
could be retrieved. The use of an HME in Western European countries as the airway
protection and rehabilitation tool was more commonly in practice (Ackerstaff.,et al,
2003). 3 RCTs were single center studies where 1 RCT and 1 cohort study were
multi-centered. All 5 articles stated the topic clear relating to the pulmonary
rehabilitation or function for patients with laryngectomy done with the use of HME.
Their study outcomes were grossly similar by measuring the compliance rates and the
pulmonary function measurement by assessing the frequency of cough, stoma
cleaning and shortness of breath at rest or during exercise. Stanislaw et al, 2010 and
Meroletal.,2011 measured secondary effects including sleeping quality, psychological
impact, nursing time spent after the application of HME. Only 3 studies mentioned
ethical approval in the journals.
2.2.3 Quality Appraisal
All the 5 journals stated the topic clearly with detailed description about their
objectives, target groups, intervention and outcomes. They can easily be traced from
the abstract of the articles respectively. 4 of the selected articles were RCTs whereas 1
was a cohort study. The involvement of randomization of the target groups were all
mentioned in the 4 RCT studies but the details was insufficient. Only the 1 RCT,
Jones.,etal, 2003, has described the details of the randomization method. It stated that
25
the randomization was conducted from a computer- generated random number
table.No randomization was involved in the identified cohort study. The patients were
informed about the use of intervention through patient letter or instruction and
informed consents.
No concealment method and binding about treatment among subjects and
investigators were adopted in allthe studies. One RCT study, Dassonville.,etal, 2011,
stated that pre-assessment by clinicians on baseline pulmonary symptoms is necessary
to evaluate the eligibility of the selected intervention group. The author stated that the
effect of no concealment and binding is limited to the study result because the
objective laboratory results and the frequency of chest infection were analyzed in
addition to subjective descriptive data obtained from the participants.
The identified studies showed to significant differences among the control and
treatment groups at the beginning of the start and the only difference between 2
groups is only the investigation treatment. The backgrounds of the participants were
listed in the tables of the studies clearly in each article stating that the male to female
ratio, mean ages, sample sizes in each groups were similar. In Dassonville.,etal, 2011,
it clearly stated that the distribution was homogenous between 2 groups prior the start
of the intervention
All of the studies clearly identified the outcome measurements. Tally sheet and
26
questionnaire are common methods used to gather the research findings. In
Stainislaw.,etal, 2009, tally sheets results were analyzed by SPSS version 15.0 with
mean, standard deviation and ranged were all computerized and reported. For the
separated questions regarding the psychological symptoms, the reliability of the
content of the questionnaire was tested by means of Cronbach’s alpha and paired t test.
In Jones.,etal, 2003, visual analog was used to validate the pilot studies. Thus, all
outcomes are measured in standard, valid and reliable way.
3 studies mentioned the dropout rate of the study groups was mentioned. The common
reasons for early discontinuation of the entire treatment are due to the occurrence of
fistula and recurrence, defaulted follow up, intolerance like skin irritation from the
HME adhesive and the anxiety experienced when the tracheostoma was covered. The
results of these participants were excluded in the result analysis.
Intention to treat refers to prevent the crossover effect between 2 groups and the
dropout. No dropouts were mentioned in the Jonesetal , 2003 and Ackerstaffetal, 2003.
For the studies with drop out, the findings of the dropout patients were not analyzed
and excluded from the sample.
Stainslaw.,etal 2009, Jones.,etal 2003 and Merol., etal 2012 were all single center
study. However, Dassonville.,etal (2011) and the Ackerstaff., etal (2003) were
multi-center with study sites in different countries including Nice, Reims, Portland,
27
Chicago and Tampa.
The level of evidence was based on the categories fulfilled by individual studied
according to the area of concern under the checklist. It was listed in the appendix 4.
After the quality appraisal of the articles, two studies ranked the highest level of
evidence with 1++ and three studies with 1+.
Dassonville., etal, 2011 was ranked as 1++ because its sample size is the largest which
included the participants from 2 centers and no drop out was found in this study. All
primary data collected are analyzed.
Jonesetal, 2003 also was ranked as 1++. Although it is single site center study,
randomization details was only included in this study which is limited in other studies
identified. Also, objective data collection like pO2 level was set as outcome
measurement in this article.
Stainslaw., etal, 2009 and Merol., etal, 2012 were ranked as 1+ because of their
relatively small sample sizes with only 50 and 53 participants involved respectively
and insufficient randomization details and single centered. However, these 2 studies
not only concern patients’ pulmonary physiologicalaspects as well as the
psychological impacts which are the more holistic research.Ackerstaff.,etal, 2003 was
ranked as 1+ in cohort study because its outcomes assessment was not made blind for
exposure and it is unknown for the extent for influence of no binding involved to the
28
outcomes.
2.3 Summary and synthesis 2.3.1 Pulmonary Symptoms
The use of HME to tracheostomy is found effective in improving pulmonary
symptoms in all 5 studies. Stainslaw.,etal, 2010 stated that the frequency of stoma
cleaning, crust removal and the occasion of mucus overproduction in the
tracheobronchial tree decreased significantly in the HME group when compared to the
control group. Also, the incidence of chest infection and the experience of shortness
of breath at rest also reduced with reference to the findings from Jone.,etal, 2003.
Experimental results from Jone.,etal, 2003 also revealed that the transcutaneous pO2
value increased significantly from 6.9kPa to 8.6kPa in the HME group which in turn
showed an improvement in the inspiratory flow-volume value. Other symptoms
including cough episodes, forceful expectorations were decreased significantly in the
intervention groups which are concluded from Merol.,etal 2011 and Ackerstaff., etal
2003.
2.3.2 Psychological Symptoms
3 studies concerned about participants’ psychological aspects after the use of HME to
their tracheostomy. All 3 articles showed that HME can improve the psychological
29
health of the post- laryngectomy patients. Stainslaw.,etal, 2010 concluded that the
level of anxiety and depression significantly decreased in the HME group at 3 month
time. Also, the sleeping quality among the participants in the HME group was also
better than the control group. The dependence on sleeping pills and the frequency of
waking up at night was reduced with significant confidence interval. Overall quality
of life was improved in the HME according to Dassonville.,etal, 2011 and Ackerstaff.,
etal 2003 suggested. The tracheostomized patients with HME were more willing to
participate in social life and the self-esteem ranks higher to their counterparts.
2.3.3 Post operation immediate use of HME
3 RCT articles, Ackerstaff.,etal, 2003;Merol., etal, 2011, Stainslaw., etal, 2010
mentioned that HME use was recommended to use immediately after patient was
returned to ward from operation theater. The earlier the patient to start the HME as the
humidification method, it can facilitate patient's adaptation and compliance rate.
Moreover, since the HME is a portable device, it keeps the patient less time to be
bedridden and promote early mobilization during the post-operative period which is
critical during the recovery stage.
2.3.4 Frequency of HME use
According to Stainslaw.,etal 2010, it concluded that HME can promote its greatest
effort on improving the pulmonary symptoms if the participants can make full
30
compliance to theHME device during the first 3months period. Full compliance
means using the HME device continuously during daytime and nighttime. The 2
studies both concluded that the improvement of the pulmonary symptoms is most
obvious and apparent in these groups of patients.
2.3.5 Conclusion
After reviewing the literatures and studies, there are strong and sufficient evidence to
propose the use of HME as the humidification devices for patients with laryngectomy
done in reducing the pulmonary symptoms suffered and in turn to relieve the
psychological distress experienced. The preliminary plan to implement this innovation
should be the ENT specialty wards in Hong Kong. This paper aims to set up an
evidence based guideline on HME use for the tranchomized laryngectomised patients.
31
Chapter 3
Translation and Application From the critical appraisal of the studies and the synthesis of the results mentioned in
the previous chapters, it is found that the application of the heat and moisture
exchanger (HME) to the tracheostomy for patients with laryngectomy done can
significantly improve the pulmonary protection and in related aspects, e.g. improved
in the sleeping quality, decreased in psychological distress, etc. To further assess the
implementation potential of this innovation in the Head and Neck (H&N) surgery
specialty wards at one of the public hospitals in Hong Kong, the transferability,
feasibility and the cost –benefit ratio of the innovation should be evaluated in this
chapter. Finally, an evidence-based guideline on the use of HME to tracheostomy
patients would be formulated with the consideration of the above mentioned factors
with the aims to improve their standard of tracheostomy care.
3.1.1 Transferability of the findings
Before evaluating the transferability, feasibility and the cost- benefit ratio of the
innovation, the characteristics of the target audience and the target setting between the
reviewed articles and the assigned clinical wards in Hong Kong should be compared.
32
The target population of all the 5 reviewed articles (Ackerstaffetal, 2003;
Dassonvilleetal, 2011;Jonesetal, 2003; Merol et al, 2012; Stainslawetal, 2009) was
adult patients with laryngectomy done due to various reasons with the opening of
trahceostomies. The mean age of the studies population was around 60-66 years old
and the mean gender ratio of male to female was around 5:1. According to the cancer
statistics in Hong Kong (2011), the mean age and the gender ratio of incidence of
nasopharyngeal cancer were around 45-64 years old and around 6:1 respectively. The
statistics findings are grossly similar to the patients’ characteristics in the studies.
The setting in the five reviewed articles are all conducted in the settings related to the
H&N department worldwide including the H&N oncology clinic, department of H&N
in two teaching university hospitals, H&N cancer center, department ENT university
hospital center and the New Voice Club. All these settings are specialized in caring
patients with tracheostomy which matched with the aimed proposed settings in Hong
Kong.
The proposed implementation clinical setting is the H&N specialty wards under
Hospital Authority (HA) in Hong Kong. According to the mission and values of the
HA (2013), it stated that“people-first” and “people-centered” organization is always
the focus of our work by achieving high quality services. HA also emphasizes the
increase in professionalism by staying abreast of the latest development of medical
33
innovation. Promotion of evidenced based practices, critical thinking and
multidirectional consideration are crucial fundamental factors in upgrading the quality
of nursing care (Melissa et al., 2008). This novel innovation perfectly matches the
philosophy of care established by HA.
Although no official statistics about the total number of tracheostomy fashioned in
HK yearly, the ward manager of the H&N ward in a public hospital claimed that an
average of 500 new patients underwent either temporary or permanent tracheostomy
surgeries annually with main indication of around 60% with carcinoma of larynx or
hypopharynx and the remaining 40% included trauma cases with respiratory distress,
sudden onset of stridor, prolonged intubation and other cancer diseases like thyroid
cancer or nasopharyngeal cancer (NPC). Among the newly fashioned tracheostomy
cases, about half of them will become candidates for permanent tracheostomies which
are an irreversible disfigurement lifelong, so the number of laryngectomized
individuals kept accumulating continuously. Thus, it is estimated that at least 300
cases will benefit from the implementation of the guideline each year.
A two-week training program will be arranged and launched for the introduction of
this innovation to the target health care professional. The program will not take too
long to implement and evaluate because HME is a relatively simple and easily
manageable device that the staff should be able to handle in within short period of
34
time. The objectives of the training program are to introduce the innovation concepts
and the guidelines well as to share clinical experience from nurses in using HME,
with the aim at increasing their interest to participate in this innovation. Sufficient
time will be provided to pilot the scheme and get familiar with the implementation to
answer the enquiry and minimize the anxiety induced by the change. A total of 8
months will be set for complete implementation and evaluation phase of the
innovation.
To summarize, the features of the target population and the setting are similar between
the studies reviewed and the clinical sites. Therefore, the transferability of this
innovation is high. It is believed that the staff can adapt the guideline in the local
setting.
3.1.2 Feasibility
After evaluating the transferability, feasibility is another crucial issue that must be
considered before carrying on to the implementation phase.
Compliance rate and the attitude towards the innovation are important concerns. In
the proposed hospital, though most of the clinicians are well aware of the necessity to
the tracheostomy humidification for compensating the loss of the upper airway
function, they do not have any preference in the selection of humidification devices.
35
The decisions are generally determined by the primary case nurses. Thus nurses are
able to exercise their autonomy and clinical judgment to carry out the innovation.
When implementing a new change, it is common that people will feel anxious and
lack confidence in adopting the new protocol. The major concerns are the increase in
workload and the fear to manage the new device. However, as Merol.,etal (2011)
suggested that the nursing care time spent on tracheostomy with HME decreased from
30 minutes to 20 minutes on average in one shift because of fewer pulmonary
complaints and better sleeping quality. Also, the design and operation of the HME is
simple, user-friendly and tiny in size. It will not occupy extra space in the tight ward
setting. It is believed that these positive outcomes can eliminate the staff resistance to
change and in favor of its application.
Gaining consensus and support from the administration is essential to conduct the
innovation successfully. The proposed target hospital has affiliated with a well-known
university in Hong Kong that emphasized the importance of clinical research and
evidence- based practice. Thus the innovation in research to improve the patient’s
outcomes is always encouraged. With the consensus from the hospital, sponsorship
can be obtained from the department of head and neck in purchasing the HME. The
department only needs to spend the extra expense for the purchase of the HME in this
project. The other resources that are necessary in monitoring the condition of the
36
tracheostomy patients like SaO2monitor and the suction systems are readily available
in the ward already. The needed resources to implement this innovation are not in
large scale, it is believed that there should not be strong resistance and
uncooperativeness in running this innovation.
Another concern is the availability of the tools for the clinical evaluation of the
innovation. A team with doctors and nurses who specified in H&N cases would be
invited to analyze comment and provide feedback to evaluate the effectiveness of this
innovation. The frequency for tracheostomy suction and dressing, the amount of
oxygen consumption, the characteristic of the sputum and chest x-ray reports will be
reviewed. These data can be retrieved via patients’ medical record. Other evaluation
tools, for example, the questionnaire can be used to collect the subjective feeling like
the satisfaction level with the treatment and the improvement in the quality of life
after participating in the innovation.
3.1.3 Cost- benefit ratio of the innovation
To assess the cost and benefit of the innovation, comparison between the benefits and
the running cost of the project should be considered. To create a complete and holistic
plan for the implementation, the potential benefits of implementing the innovation
should be analyzed and at the same time the potential risk of the patients exposed
37
during the innovation should be addressed too.
The proposed interventions are to set up an evidence- based guideline for using HME
as the humidification system for tracheostomy patients. When using HME, there is a
potential risk of skin allergy for the adhesive material on the surface of the HME.
Around 1-3% of the clients in the studies showed skin itchiness and redness for the
HME use (Ackerstaff.,etal 2003). However, the severity of the allergy is mild and can
be subsided through topical cream application. No dropout was noted in the 5
reviewed studies with this reason. If the wards continue to use the external
humidifying machine as the humidifying device, there is a risk of the outbreak of the
infectious disease. It is observed that no standard sterilization has undergone in the
current clinical practices in the local setting, the tubing of external humidifying
machine will be reused after cleansing in the ward only. Some resistant virus like
vancomycin resistant enterococci (VRE) will have high chance of cross-infection and
lead to outbreak. Nevertheless, HME is a single-used and readily disposable item
which can greatly minimize the drawback of external humidifying machine for the
risk of cross- infection.
According to Merol.,etal (2011), the mean cost of a HME is around HKD $12 with
the mean number of HME use is 2.5 cassettes per day. Thus the daily cost of HME use
is around HKD$30 whereas the daily cost of using the EH machines is around
38
HKD$34. Therefore, the daily cost of using HME is lower than that of the EH
machines by HKD$4. Approximately, there are 100 eligible cases will be admitted to
target hospital and their average hospital stay length is 90days. The training cost of
setting up the innovation costs around HKD$8750 and the running cost of the HME
and EH use per year was around HKD$270,000and HKD$306,000 respectively. A
reduction of around HKD$36000 can be saved with this new clinical innovation
annually. Details of the cost calculation are shown in appendix 5.
Non material benefits have been reported in the reviewed studies too. Research
studies suggested that the application of HME with 3 month period can significantly
reduce the pulmonary symptoms like decrease in the rate of forceful cough, chest
infection and experience of shortness of breath (Merol et al.,2011, Jones et al,2003,
Dassonville et al.,2011). These non-material benefits can cause reduction in other
material cost like the use of antibiotics and the consumption of oxygen during
hospitalization. Non material cost like patient’s compliance rate and nurses’
satisfaction level also found increased in these findings too.
After considering various aspects of the innovation, though additional cost is required
for running the innovation, the benefits of HME use are still more important than the
potential risk and cost from the patients’ and health worker perspectives and thus
should be implemented.
39
3.2 Evidence based protocol
After identifying the transferability, feasibility and the cost- benefit ratio in the
previous session, an evidence- based guideline that based on the findings of the
reviewed articles was developed. The methodology used to grade the articles was
designed by the Scottish Intercollegiate Guideline Network (SIGN, 2013) and the
recommendation was graded according to the description of the level of evidence,
Two of the reviewed articles were classified as the highest level 1++ (Dassonvilleetal.,
2011; Jones etal., 2003), three were ranked as 1+ (Ackerstaffetal., 2003; Meroletal.,
2012; Stainslawetal., 2009). An Evidence Based Clinical Guideline of tracheostomy care using HME
humidification on pulmonary protection for patients with laryngectomy done Introduction:
The loss of the function of the upper respiratory tract due to the tracheostomy
will cause the entrance of unconditioned inhaled air will cause colder and dryer
air to the trachea and bronchi, inducing various pulmonary problems like
excessive phlegm production, involuntary coughing and forceful expectoration
(Merol et al, 2012). Therefore, humidification is a critical component for the
pulmonary protection for laryngectomees. To overcome the discomfort and
40
improve compliance caused by the traditional humidification method, heat and
moisture exchanger (HME) was introduced for tracheostomy patients. HME is
recommended for better protection of the pulmonary functions of the
tracheostomy patients.
Objectives: 1) To provide recommendation for the use of HME as the tracheostomy
humidification devices for patients with laryngectomy done with evidence support
2) To promote better patient outcomes in term of HME use by improving the
pulmonary function
Target Population
Adult patients with laryngectomy done with the opening of tracheostomy
Target User of the Guideline
The guideline aims for the nurses working in the ENT and the H&N department
where the guideline will be implemented.
Recommendations:
1) HME should be used for all laryngectomized patients for improving the
pulmonary functions (Grade of Recommendation: A)
41
Evidence:
The frequency of stoma cleaning, reflecting crusting and overproduction of
mucosal secretion on the tracheobronchial tree reduced significantly in the
HME group (Stanislaw etal,2010, 1+)
Fewer cough episodes and less need for active mucus expectoration is seen in
the HME group (Meroletal, 2011,1+)
Cough, chest infection , mucus production and shortness of breath at rest
were all significantly reduced in the HME group and a highly significant
increase in transcutaneous pO2 value (Jones etal, 2003, 1++)
The evolution of cough and bronchorrhoea had shown statistically significant
reduction in HME groups at 3 month time in comparison to control group
(Dassonvilleetal, 2011, 1++)
Statistically significant decrease in coughing complaints, sputum production,
forced expectoration and less need for stoma cleaning is noted in HME group
at 3-months time (Ackerstaffetal., 2003, 1+)
2) HME should be used to improve the psychological health of the
post-laryngectomy patients (Grade of recommendation: A)
Evidence:
42
Feeling of anxiety and depression had significantly increased at control group at 3-month time and in the HME group no significant changes in the feeling of
anxiety and depression (Stainslawetal., 2010, 1+)
The frequency waking up at night and the use of sleeping medication reduced
in HME group whereas in the control group almost all patients (97.5%) has
sleeping problem (Stainslawetal., 2010, 1+)
The patients using the HME device felt an overall improvement in their
breathing, leading to an improvement on their quality of life (Dassonvilleetal.,
2011, 1++)
HME group viewed an improvement in quality of life, they were more willing
to communication, participate in social life, slept better and felt better about
themselves (Ackerstaffetal., 2003, 1+)
3)
HME should be used immediately after laryngectomy (Grade of
Recommendation: B)
Evidence:
HME use as soon as the patient has returned to the ward after the total
laryngectomy. In this way, patients becomes accustom to and familiar with an
HME in the earliest stage (Ackerstaffetal., 2003, 1+)
The use of HME should be implemented in the early post operative period for
43
the pulmonary protection (Stanislaw etal., 2010, 1+) HME does not keep the patient bedridden and therefore allows the early
mobilization in the postoperative phase without compromising airway
humidification (Meroletal., 2011, 1+)
Immediate application can accentuate the patient the importance of this
medical device in aftercare and pulmonary rehabilitation and enhance overall
compliance (Meroletal., 2011, 1+)
4) HME should be used day and night for its greatest benefits (Grade of
recommendation: B)
Evidence: The extent of pulmonary protection is most significant in the full compliance
group (use HME day and night) in all measuring outcomes.
(Stainslawetal., 2010, 1+)
44
Chapter 4
Implementation Plan After the development of the evidence- based guideline of the innovation, the
implementation plan, including the communication plan with the potential users and
the pilot plan study will be discussed in this section. These plannings are important
and essential to ensure the feasibility and transferability of the innovation into
practice.
4.1 Communication Plan
Identifying the stakeholders is the first step for carrying out the communication plan.
The stakeholders refer to the people who are involved in the proposed new innovation.
The assessment of the influence and the adaptation of the changes among the
stakeholders are important for achieving the successful pathway of the innovation.
Concerning about the implementation of Heat Moisture Exchanger (HME) in
decreasing the pulmonary symptoms on patients with tracheostomy performed in head
and neck unit, the main stakeholders are the administrators, physicians, nurses. The
administrators include the Chief of Service (COS) of the Head and Neck Department,
the Department Operation Manager (DOM) and the Ward Manager (WM). They are
45
responsible for the approval of the innovation and to offer essential resources to
launch the innovation. For the physicians and nurses, they are the frontline staff to
perform the new practices and act as the vital role in providing valuable suggestions
and comments in modifying and smoothing the launch of the innovation. The
Advanced Practice Nurse (APN) takes part as the leading role for monitoring and
assisting the staff during the implementation phase. Last but not least, the patients and
their significant relative are the important ones because they are the treatment receiver
and their full cooperation to the treatment plan can facilitate the progress of the
innovation.
4.1.2 Communication process and the implementation strategies
The initiations of the proposed innovation start by gaining the consent and funding
and resources from the Head and Neck Department administrators. Latest evidence
practices, the implementation benefits and potential, the approximated manpower and
the needed resources will be presented clearly to the managerial staff. An organizing
committee will be set up to hold this innovation. The committee is responsible for
planning, implementing and evaluating the innovation in different intervals to ensure
the program is carried out smoothly. This working group also acts as the
communication channel to listen the comments from frontline staff and the related
46
parties to make adjustment to fit their needs. At the beginning, a presentation will be
organized aiming to provide a platform for them to understand the significance of the
proposed innovation and this novel act will bring them beneficial change to patients
and in clinical practices. After gaining the approval, meetings will be arranged to
three to four APNs who are nominated by the innovation committee teams as the
program coordinators of this innovation. They are selected from COS, DOM and WM
by considering their experience in H&N cases, especially in tracheostomy cases. They
will discuss the workflow on how to integrate the innovation in patients’ care in detail
and set the timeframe for monitoring the progress and refine it if necessary. They are
the facilitators and trainers as they should have a full understanding of the idea of the
program aim. After that, training classes will be organized to different parties
including nurses and other potential users e.g., health care assistant of the innovation.
For the key users like nurses, a 2-hours training for 2 weeks will be provided on the
operation of the HME, the indicators need to monitor when applying this device and
the details of the guideline should be mentioned. The training session in the first week
will mainly focus on the demonstration and introduction of the device. In the second
week, return demonstration and independent application of the device will be
emphasized. A brief session around 1 hour will be provided to other users including
health care assistant to learn the basic knowledge of the innovation.
47
To state the clear vision of the change, the severity of the current clinical problems
will be highlighted by showing evidence-based literature as back up support. This can
facilitate the initiation and promotion for the application of the guideline. Another
issue which should be addressed is to estimate the extent of support or resistance to
the proposed change. Early notification and query session can give users sufficient
time to understand and clarify the innovation. Posters, focus group interviews before
the implementation phase can improve the acceptance of the proposed innovation
among the nurses. The guideline will be delivered to all stakeholders by internal email
and a hard copy will be kept at bedside for easy access.
Setting up clear vision with deadlines is effective to guide the innovative change
systemically. A 12-month tentative timetable is proposed using a Gantt Chartto trace
theworkflow stage easily (Appendix 6). Pre-implementation training is provided to all
clinical nurses working in H&N specialty. Details of the innovation will be illustrated
via questions and answers in order to clarify queries. The APNs in the training class
will assist in trouble-shooting and introduce the new protocol. A timely review and
regular meetings are necessary todisseminate up-to-date information. Offering more
communication channels such as group discussion, informal meeting can allow early
identification of the restraining forces by the frontline staff and to facilitate resolution
of the problems. Gaining staff support results in bettercompliance.
48
To sustain the change process in long run depends greatly on the compliance of the
staff. Audit and evaluation can ensure the guideline is followed with standard quality.
Staff satisfaction and client outcome are core indicators to determine the success of
feasibility and transferability of the innovation. Sharing session shortly after the
implementation can raise the problem encountered and discuss for solution. Regular
updates and revision of the guideline are crucial.
4.2 Pilot testing plan
A pilot study before the full scale implement can determine the feasibility and the
applicability of the proposed change. The operational cost and the guideline
adherence can also be assessed and estimated through the pilot test. The patient
recruitment strategies, the guideline, data collection and the evaluation tool will be
investigated. The aims of the pilot testing are to make modification and amendments
of the guideline before full implementation. Also, through the pilot program, it aims to
gain the acceptability from the chosen patients and the support from various health
professional groups.
4.2.1 Subject recruitment strategies
In the pilot testing, the inclusion and exclusion criteria will try to stay similar as the
49
proposed guideline. Adults with age equal to or older than 18 of both genders with
total larynghectomy done with the presence of tracheostomy will be recruited whereas
cases with metastatic or recurrence in other parts of the body will be excluded.
Convenient sampling will be adopted. It is expected to recruit 10-15 tracheostomy
patients during the test phase which is around ¼ of the estimated number of eligible
clients in the implementation phase. The selected subjects will first be screened for
the eligibility by the designated APN and doctors. The complete pilot testing will take
about three months from the selection of candidates to the evaluation phase.
4.2.2 The guideline
A guideline helps to determine and consolidate the feasibility of the innovation. The
guideline should be accessed readily in both soft and hard copy. It should also be
written in simple and user friendly format. The monitoring and evaluation process
will be done by the primary case nurse. There will be a grand nurse round weekly to
monitor the progress and to receive the responses from the frontline staff. The grand
round is important to gather the opinion from different parties to further refine the
guideline before launching the innovation.
4.2.3 Logistics
50
Logistics includes the manpower, duration of the intervention and the workflow.
Review by the users in the pilot phase can give extra comments to set up the more
appropriate logistic arrangement. In addition, the subject enrollment logistics will be
organized by the designate APNs to discover if there are any difficulties in selecting
the eligible target group.
4.2.4 Methods for collecting data
Both quantitative and qualitative data will be collected in the pilot study. Quantitative
data include the demographic data (i.e. age, gender), patients’ chief diagnosis and the
indication of tracheostomy opening, primary outcomes like the frequency of cough,
stoma cleaning and secondary outcomes like the experience of insomnia and the
nursing time spent on patients with the humidification device. Qualitative data
includes the nurses’ acceptance towards the innovation, the degree of job satisfaction,
comments and compliance of the guideline. For the quantitative data, the data can be
recorded by the case nurse and comparison can be made before and after the
implementation. Patient chart is crucial in gathering quantitative data. The charts will
be reviewed by the program coordinators to minimize the missing and incorrect data.
For the qualitative data, the case nurse will receive the self- report questionnaires. The
research clerk will input and analyze the data.
51
4.2.5 Methods of evaluating effectiveness
To determine the effectiveness of the proposed innovation, it is expected to achieve
the primary outcomes, which are the reduction in pulmonary symptoms generated by
the tracheostomies. A post pilot study meeting will be held shortly after the pilot study
to review the strength, weakness and the potential problems of the innovation. Better
feasibility, transferability and acceptability should be achieved after the meeting. This
can facilitate the committee to make final adjustment of the logistic workflow and
reveal the deficiencies prior to the full- scale implementation.
52
Chapter 5
Evaluation Plan After the evaluation of the pilot study, a revised version of the proposed guideline will
be generated to ensure the feasibility and the transferability towards the full scale
implementation clinical trial. A pre- and post- test comparing the pulmonary
complaints will be carried out in this innovation. The evaluation plan in this session
will give detailed information to the stakeholders about the clinical benefits of the
innovation brought so they can determine whether the change is worthwhile to
proceed. The whole completion of the evaluation process is estimated to finish by 2
month time.
5.1 Identifying Outcomes
The core innovation purpose of HME is to minimize the pulmonary complications in
patients with tracheostomies. Thus, the patients’ outcomes are the highlighted focus.
The primary outcome is the prevalence of pneumonia in tracheostomy patients
receiving HME. As the anatomical changes of shortening the respiratory tract for the
tracheostomy patients and the skin breakdown during the tracheostomy insertion, the
risk of pneumonia is higher in tracheostomy patients than in normal person.
53
According to Behnia et al (2014), the diagnosis of pneumonia in tracheostomy
patients was made by the inflammatory tracheostomy appearance and the radiographic
findings of new infiltrate or consolidation. Other signs of tracheostomy pneumonia for
example with fever >38 ℃ , leukocytosis, increase in tracheobronchial mucus production, worsening oxygenation and positive blood culture. It is selected as the
primary outcomes because pneumonia complications are identified as the prime
complaints from the tracheostomy patients.
The secondary outcomes are related to the psychological aspects e.g. the experience
of fatigue and the sleeping quality of the tracheostomy patients. Also, the compliance
rate and the satisfaction from the health care workers are also included in the
secondary outcomes. Sleeping quality reflects an occurrence of insomnia,
consumption of sleeping pills of the tracheostomy patients. Actually, the quality of
sleep is interrupted by the forceful cough and shortness of breath. Furthermore, they
are the indirect signals of pulmonary complication. Health care outcomes including
the job satisfaction, confidence in carrying out the innovation independently, support
from program coordinator and clarify of the guideline should be concerned too. Self-
report questionnaire and the focus group which focus in the mentioned areas will be
performed. The score of the questionnaire will be set as “very satisfied (5), satisfied
(4), neutral (3), not satisfied (2), very not satisfied (1).
54
Furthermore, the system outcome is another integral component in the evaluation
process. From the managerial perspectives, it is important to reduce the cost and
enhance the utilization of current resources. The evaluation plan is to examine
whether the resources are properly and fully utilized and whether the manpower is
appropriate. From the views of the administrators, successful in reducing the cost and
the maintenance of the standard of the professional service is the most desirable
outcomes.
5.1.2 Data measurement
The patients’ demographic data, diagnosis and the indication for the opening of
tracheostomy will be documented once they are recruited to receive the HME. Data
collection is done by the primary nurse. When the target patient is recruited to the
innovation, the vital signs and the tracheostomy cleaning frequency will be
documented at least once per shift. Other data including the frequency of forceful
cough and the experience of shortness of breath can be recorded by patients
themselves if their condition allows. Laboratory and radiography result like the white
blood cell count and the chest X-ray film should be checked routinely at least once
per week and recorded systematically. Microbiology findings including the culture
should also keep in record to examine the underlying cause of pulmonary
55
complication.
The length of ward stay either in ICU or ENT ward will be recorded when the 6
month implementation phase is over or the patients are transferred out to other
hospital or certified death. Since this data will take longer time to collect, it is
considered as intermediate measurements. The measurement of the level of
satisfaction of the health care providers is set as the intermediate to long term
measurement during the implementation because regular evaluation will be performed
at different stages of the innovation including the pre-implementation stage,
implementation stage and the post- implementation stage.
By the end of the implementation phase the cost effectiveness and the utilization and
compliance rate can be calculated. The information is reviewed yearly and is regarded
as long term measurements as the previous annual report will be used to predict and
modify the future development of the innovation
5.1.3 Nature and number of clients to be involved
The suggested innovation involves both the patients and the nurses in the Head and
Neck Department. Therefore, evaluation should be conducted in both parties.
Characteristics of eligible patients are chosen based on the evidence of the selected
articles. Inclusion criteria include adult patients aged 18 or above with total
56
largngectomy done with the presence of tracheostomy. Exclusion criteria are those
patients with temporary tracheostomy only or complicated cases with metastatic
laryngeal cancer.
Convenience sampling will be adopted to recruit patients for the 6-month
implementation period. The eligible patients will receive the HME at the last 3
months of the implementation phase. Clinical outcomes with and without the use of
HME for 3 months respectively will then be retrospectively compared to show the
finding of before and after use.
Sample size is estimated using an online computer program JAVA Applets for Power
and Sample Size (Lenth, 2006-9). The primary outcomes evaluation is to determine if
the HME can reduce the occurrence of forced expectoration via tracheostomy by
means of significance testing. Z- test for one proportion is applied. With reference to
the reviewed studies, the reduction of forceful cough after the use of HME on
tracheostomy were 14.3%, 18% and 29% respectively (Meroletal., 2011, Dassonville
et al., 2011, Ackerstaff et al., 2003). Hence, an average of 31% reduction of forceful
cough experienced is set in the calculation.
According to the journal of pulmonology about the prevention of ventilator-
associated pneumonia (Oliverira et al., 2014), the rate of pneumonia associated with
tracheostomy on mechanical ventilation ranged from 8-28%. Assuming the pulmonary
57
complication causing pneumonia lies around the midpoint of the literature result (i.e.
18%), the potential rate of suffering pneumonia after this innovation will be reduced
to 9%. Setting the power of 80% and the significance level of 5%, the estimated
sample size is 42. In the target setting, there are 26 registered nurses, 4 APNs and 1
ward manager. Self- report questionnaire and focus group interview among the
doctors and nurses involved will be organized. These are inexpensive, elaborative way
for gathering information.
5.1.4 Data Analysis
Descriptive statistics will be applied to illustrate the outcomes. For the quantitative
data, significance testing with performing a two-tailed paired t test will be used to
evaluate the prevalence of the pneumonia. Chi square test will be performed to
compare the demographic data a presented with mean and standard deviation. p- value
<0.05 is accepted as statistically significant. Qualitative data like the job satisfaction and the training sufficiency, self-report
questionnaire are rated by numerical grade as (5), (4), (3), (2), (1). Other comments
collected from the focus group will be classified into different key themes. These key
themes will then be synthesized for review.
5.1.5 Determination of the protocol effectiveness
58
The evidence-based guideline on the HME use to reduce the pulmonary complications
in tracheostomized patients is regarded as effective if the primary outcome is achieved.
With reference to the reviewed study, the incidence of the pneumonia was reported to
reduce by 33.4-47.7% (Meroletal., 2011, Jones et al., 2003, Dassonville et al., 2011,
Ackerstaff et al., 2003, Stanislaw et al.,2010). Thus, the clinical effectiveness is this
study is quantified as 41% reduction in the implementation period compared with the
3 month experimental period.
For the secondary outcomes, the reduction in the experience of fatigue, sleeping
problem ranged from 5.7-7% (Stanislaw et al., 2010) and so a 6.35% reduction is
concluded as effective. In the reviewed articles, no related findings about the length of
stay in the ward were retrieved. The protocol effectiveness is determined by the
analyzed experimental and control group. Overall positive outcomes regard the
protocol as effective.
In term of health care provider outcomes, the innovation is regarded as effective if the
rate is graded at least of score 3 or above. Grades ranked below 3 represent
dissatisfaction. In regard to the system outcomes, it is expected to increase the
utilization of the resources and the manpower arrangement and not exerting extra
workload to staff. It is estimated a reduction of HKD$36000 can be achieved per
annum.
59
Conclusion Lifelong tracheostomy indeed keeps patients prone to pulmonary complications. It is a
significant clinical issue in ENT specialty for delaying patients’ recovery, prolonged
length of hospital stay and increased the cost of care. The integrated review of the
evidence showed that HME is effective to improve the pulmonary protection in
tracheostomized patients. After the assessment of the implementation potential, the
feasibility and the transferability, it is expected there will be clinical benefits to
patients’ outcomes, improvement of staff moral and lower the cost of care in the target
setting. An evidence- based guideline is synthesized and translated from current
studies into innovation practice. With the well-organized communication plan to
stakeholders and the pilot study in actual setting, it is believed the intervention can be
smoothly implemented. Further evaluation will be done to sustain the guideline in
long run.
60
Appendix 1--Searching Process
Pubmed
Proquest
British Nursing Index
Date of search
10.03.2013
18.08.2013
20.08.2013
Keywords used
“Heat and
moisture
exchanger” and
“tracheostomy”
“Heatand moisture
exchanger” and
“tracheostomy Or
laryngectomy”
“Heat and
moisture
exchanger” and
“tracheostomy”
Results
19
20
116
Limitation
Human, 10 years
Human, 10 years
10 years
Result
5
14
68
Reviewed by titles
4
5
15
Reviewed by
abstracts
2
2
4
Reviewed by full
articles
1 RCT
1 RCT
1RCT
61
Appendix 2 Table of Evidence
Bibliographic citation
Study type Patient characteristics
Number of patients
Intervention Comparison Length of follow up
Outcome measures
Results
Stanislaw et al., 2010
RCT (1+) Patient who has undergone total laryngectomy at least 6 months ago and they are being studied during winter period
Mean age: 62
N=80 Intervention group=40 (4 dropped out during the study)
Control group=40
Intervention group: use of HME (Heat and Moisture Exchanger) to their permanent tracheostomies during the study
Control group: Without the use of HME to their permanent tracheostomy
To compare the pulmonary function of the tracheostomy and the quality of life change
3 months
Primary:
1) Frequency of coughing,
forced expectorations
2) Frequency of stoma
cleaning
3)Experience of shortness of
breath
(SOB)
Secondary:
1) Fatigue
2)Sleeping problems
3)Psychological well being
(depression, anxiety)
- 26/day (HME group) P<0.001
-0.7times /day
P=0.001
HME group experienced a
significant increase in SOB while
climbing steps.
P=0.012 (HME)
P= 0.006 (control)
no significant difference
t test
-7% of sleeping problem
- 5.7% of sleeping pills use
Control gourp: significant
increase anxiety and depression
(P=0.003)
62
Bibliographic citation
Study type Patient characteristics
Number of patients
Intervention Comparison Length of
follow up
Outcome measures
Results
Merol etal., 2011
RCT (1+) Patients who has undergone scheduled total laryngectomy surgery in 2 teaching university hospitals in France
Mean age:60
N= 53 External humidifier (EH) group: 26
Heat and Moisture Exchanger (HME) group: 27 4 drop out
EH group: To use EH for supplying warm and moist air
HME group: To use HME to maintain and restore the moisture generated by patient during spontaneous breathing
To compare the pulmonary function and the quality of life change after using the EH and HME respectively
1 year and 3 months
Primary
1) Compliance
rates
2) Frequency of
mucus
expectoration
3) Frequency of
coughing >10
times
Secondary
Nursing time
spent on patient
care related to
the
humidifaction
devices
Primary -47.7% (HME vs EH) (P<.001)
-3 times /day(HME vs EH) (P<.001)
-14.3% (HME vs EH)
(P<.001)
-10mins/day (HME vs EH) P<.001
63
Bibliographic citation
Study type Patient characteristics
Number of patients
Intervention Comparison Length of
follow up
Outcome measures
Results
Jones etal., 2003
RCT (1+) Patients who has undergone total laryngectomy with permanent tracheostomy at head and neck oncology clinic in UK
N=50 Intervention group (HME)= 25
Control: Group= 25
Intervention
group: apply
the HME
stoma filter to
the trachstomy
Placebo group:
Without the use
of HME to the
tracheostomy
To compare the pulmonary function of patients among 2 groups
6months
1) Cough
2) Chest
infection
3) Shortness
of breath at
rest
4) Shortness
of breath
during
exercise
5) pO2
(mmHg)
Visual analog of 10cm in length
were used for outcome
measurement .Scale “0”
represents no symptom and
scale”10” represents the worst
symptom
-3 scale (HME vs control)
-1 scale ( HME vs control)
-0.2 scale (HME vs
control)
-1.3 scale (HME vs
control)
+14.2 mmHg (HME vs
control)
64
Bibliographic citation
Study type
Patient characteristics
Number of patients
Intervention Comparison Length of follow up
Outcome measures
Results
Dassonville RCT Patients who N=60 Intervention To compare 12 1)Dyspnoea -18% (HME vs
etal., 2011 (1-) have group: apply the months control)
undergone Intervention the Provox functional (P=0.0174)
laryngectomy group =30 HME to the respiratory At 3 month trend
in ENT trachstomy symptoms
department in Control among 2 2)bronchorrhoea Statistically
Nice or Reims group = 30 Placebo group: groups significant
Without the improvement in
Mean age: 65 use of HME to intervention group
the (P=0.0031)
tracheostomy from 6 weeks use
3)cough
statistically
significant in
intervention group
in reduction of
cough from 3
months use
65
Bibliographic citation
Study type Patient characteristics
Number of patients
Intervention Comparison Length of follow up
Outcome measures
Results
Ackerstaff etal., 2003
Cohort study
Patients with laryngectomy operations done at least 6 months. They are recruited from 4 multi centerstudy based in United States
Mean age: 66
N=170 162
Intervention group (HME): 89 8 excluded
Control group: 81
Intervention group: apply the HME to the tracheostomy
Control group: Without the HME use to the tracheostomy
To compare the frequency of pulmonary complaints among 2 groups
3 months 1) Cough
2) mucus
secretion
3) Forced
expectorat ion
4) stoma
cleaning
-43% (HME vs
control)
-51% (HME vs
control)
-29% (HME vs
control)
-9% (HME vs
control)
66
Appendix 3 Critical appraisal for the retrieved RCTs by SIGN 2013
Stanislaw et al., 2010 Merol etal., 2011 Jones etal., 2003 Dassonville etal., 2011
1.1 The study addresses an appropriate and clearly focused question. Yes Yes Yes Yes
1.2 The assignment of subjects to treatment groups is randomized. Yes Yes Yes Yes
1.3 An adequate concealment method is used. No No No No 1.4 Subjects and investigators are kept “blind” about treatment
allocation.
No No No No
1.5 The treatment and the control groups are similar at the start of
the trail
Yes Yes Yes Yes
1.6 The only difference between groups is the treatment under
investigation.
Yes Yes Yes Yes
1.7 All relevant outcomes are measured in a standard, valid and
reliable way.
Yes Yes Yes No
1.8 What the percentage of the individuals or clusters recruited into
each treatment arm of the study dropped out before the study
was completed?
10%, 4 dropped out in
the HME group
15%, 4 dropped out in
the HME group
0% , no dropped out
either in intervention
or control group
Not address
1.9 All the subjects are analyzed in the groups to which they were
randomly allocated (intention to treat)
Yes Yes Yes Yes
1.10 Where the study is carried out at more than one sites, results are
comparable for all sites.
Does not apply Does not apply Does not apply Yes
67
2.1 How well was the study done to minimize bias?
Acceptable + Acceptable + Acceptable + Acceptable +
2.2 Taking into account clinical consideration, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?
Yes Yes Yes Yes
2.3 Are the results this study directly applicable to the patient group targeted by this guideline?
Yes Yes Yes Yes
68
Critical appraisal for the retrieved Cohort study by SIGN 2013
1.1 The study address an appropriate and clearly focused question Yes 1.2 The 2 groups being studied are selected from source populations that are
comparable in all respects other than the factor under investigation Yes
1.3 The study indicates how many of the people asked to take part did so, in each of the groups being studied
Yes
1.4 The likelihood that some eligible subjects might have the outcome at the time of enrolment is assessed and taken into account in the analysis
Yes
1.5 What percentage of individuals or clusters recruited into each arm of the study dropped out before the study completed
No drop out but 8 patients in the intervention group were excluded
1.6 Comparison is made between full participants and those lost to follow up, by exposure status
Yes
1.7 The outcomes are clearly defined Yes 1.8 The assessment of outcome is made blind to exposure status No 1.9 Where binding was not possible, there is some recognition that knowledge
of exposure status could have influenced the assessment of outcome Can’t say
1.10 The method of assessment of exposure is reliable Yes 1.11 Evidence from other sources is used to demonstrate that the method of
outcome assessment is valid and reliable Yes
1.12 Exposure level is assessed more than once Can’t say 1.13 The main potential confounders are identified and taken into account in the
design and analysis No
69
1.14 Have confidence interval been provided? Yes 2.1 How well was the study done to minimize the risk of bias or confounding? Acceptable + 2.2 Taking into account clinical consideration, your evaluation of the
methodology used, and the statistical power of the study, how strong do you think the association between exposure and outcome is?
Quite strong association
2.3 Are the results this study directly applicable to the patient group targeted by this guideline
Yes
71
Appendix 5 Cost of staff for setting up the innovation
Staff
Time
Cost
Total Cost ($HKD)
5 coordinated nurse
1 teaching hour
$250/hour
$1250
30 nurses
1 teaching hour
$250/hour
$7500
$8750
Material Cost for HME per patient per one day
Number
Cost (HKD$)
Total Cost (HKD$)
HME
2.5
12
30
Material Cost for HME per patient for 30 days of hospitalization:
$30x90=$2700
Material Cost for HME for 100 patients for 90 days:
$2700X100=$270,000
Material cost of EH per patient per 1day
Daily Expense (HKD$)
Total Cost (HKD$)
EH
34
34
Material Cost for EH per patient for 90 days:
34x90=$3060
Material Cost for FH for 100 patients for 90days: $3060x100=$306,000
72
Appendix 6 --Staff satisfaction questionnaire 耳鼻喉科- HME 造氣口護理計劃 員工滿意
問卷調查請於下列適當位置填上”√”
病人標籤
對於造氣口護理計劃... 非常同意
同意
中立
不同意
非常不同意
1. 我了解 HME 造氣口護理計畫的目的
2.我應為計畫能帶給病人好處
3.我了解計劃的內容
4.我有足夠時間去預備參與計劃
5.我得到足夠支援
6.我覺得計劃易於使用
7.我從中得到成功感
8.病人願意合作及遵從計劃
9.同事間對計劃的態度是正面的
10.計劃進行間我遇到很多困難
11.計劃易於融入我現時的工作
12.我易於取得計劃的資料
13.我認為此計劃是值得長遠推廣及
進行
14.我有充分信心執行計劃
74
Appendix 7-- Patient Satisfaction questionnaire 耳鼻喉科- HME 造氣口護理計劃 病人滿意
問卷調查請於下列適當位置填上”√”
病人標籤
參與計劃前.. 非常同意
同意
中立
不同意
非常不同意
1.預備資料是足夠的
2.了解計劃風險及好處的
3.有足夠時間去了解疑問
4.清楚了解住院期間使用 HME 的護理計劃程序
參與計劃後..
1.你認為 HME 造氣口護理計劃對你有呼吸舒適度有幫
助
2.計劃指引是清晰及容易跟隨的
3.你易於掌握護理計劃的資料
4.你有信心遵循計劃指引
5.你覺得醫護人員的協助是足夠的
6.你明白計劃的好處
7.計劃對你做成困擾
8.你滿意醫護人員的照顧
其他安排
1.你出院後會繼續使用 HME 作造氣口護理
2.你知道如何在出院後尋求關於此計劃的協助
3.你對整個護理計劃感到滿意
76
Appendix 8—Satisfaction Questionnaire of the training session
Please ”√”the following
Very satisfied (5), satisfied (4), Netural (3), dissatisfied(2) and very dissatisfied (1)
1
2
3
4
5
1
Content of the training session are relevance
2
Content of the training session are practical
3
Duration of the training session
4
Skills of the speaker in the training session
5 Self-competent to use HME humidification device after
the training session
Other comment:
Name:
Job Title:
Date:
1 2 3 4 5 6 7 8
Appendix 9 Gantt chart for implementation of HME humidification to tracheostomy
Month
Seek approval from administrators
Recruit program coordinators and 1st meeting
Marketing of the program
Pilot testing of the protocol and program logistics
Hold 2nd meeting for protocol amendment and operational logistics
Pre-implementation training
Implementation of the HME to tracheostomy
Evaluation of outcomes
3rd meeting: Evaluation meeting
77
78
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heat and moisture exchanger use on respiratory symptoms and voice quality in
laryngectomised individuals. Otolaryngology--Head and Neck Surgery,
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Akenroye, M. I. &Osukoya, A. T. (2012). Permanent tracheostomy: Its social impacts
and their management in Ondo State, Southwest, Nigeria. Nigerian Journal of
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Behnia, M., Logan, S. & Fallen, L. (2014). Nosocomial and ventilator-associated
pneumonia in a community hospital intensive care unit: a retrospective review and
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Bowers, B. &Scase, C. (2007). Tracheostomy: facilitating successful discharge from
hospital to home. Br J Nurs, 16 (8), 476-479.
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Dassonville, O., Merol, J. C. &Bozec, A. (2011).Randomized,multi-centre study of
the usefulness of the heat and moisture exchanger (Provox) in laryngectomised
patients . Eur Arch otorhinolaryngol, 268 1647-1654.
Dennis-rouse, M. D. & Davidson, J. E. (2008).Crit Care Nurs Q. An Evidence-Based
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Garrubba, M., Turner, T. &Grieveson, C. (2009). Multidisciplinary care for
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Gilony, D., Gilboa, D. & Blumstein, T. (2005).Effects of Tracheostomy on
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Jones, A. S., Young, P. E. &Hanafi, Z. B. (2003). A study of the effect of a resistive
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Oliveira, J., Zagalo, C. &Cavaco-silva, P. (2014).Prevention of ventilator-associated
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