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.

4

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

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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

14

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

21

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

70

Appendix 4 Level of Evidence

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

73

你對整個計劃最滿意的地方: 你對整個計劃最不滿意的地方:

你對計劃的其他意見:

**謝謝你的寶貴意見及時間**

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

75

你對整個計劃最滿意的地方: 你對整個計劃最不滿意的地方:

你對計劃的其他意見:

**謝謝你的寶貴意見及時間**

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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