Usability, feasibility, and safety test of a new ...

Original Article

Usability, feasibility, and safety test of a new thermosensitive liquid crystal film

for the early detection of extravasation in clinical practice: A pilot study

Mari Abe-Doi1)

; Ryoko Murayama1) 2)

; Hidenori Tanabe3)

; Emiko Kamiyama4)

;

Chieko Komiyama4)

; Yuko Matsui5)

and Hiromi Sanada2) 6)

1)Department of Advanced Nursing Technology, Graduate School of Medicine, the University of Tokyo

2)Global Nursing Research Center, Graduate School of Medicine, the University of Tokyo

3)Research and Development Center, Terumo Corporation

4)Department of Nursing, The University of Tokyo Hospital

5)Department of Nursing, Faculty of Health Sciences, Komatsu University

6)Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, the University of Tokyo

Abstract

Early detection of extravasation is important due to possible drug leakage, which can cause severe tissue damage.

However, its signs and symptoms are difficult to be assessed, and objective assessment is necessary. Given that fluid

accumulation provides a low skin-surface temperature, a thermosensitive liquid crystal film was developed to be used as

a noninvasive, continuous, and safe extravasation assessment tool. This study aimed to confirm its usability, safety, and

feasibility for visualizing skin temperature in the clinical setting. This study included clinical nurses and outpatients who

received chemotherapy. No extravasation occurred. Forty patients and 8 nurses were included. All patients responded

that they did not mind using the film, and they did not experience any side effects due to using the film, such as itching,

tightened feeling, or other discomfort. Nurses placed the film on a catheter securement film and routinely administered

drugs. Nurses evaluated the usability of the film after every use. The frequency of observation remained unchanged,

according to 80% of the nurses:answers. It suggested that additional treatment time due to film use was acceptable.

During treatment, the skin-surface temperature distribution pattern was recorded using a camera. The temperature

distribution patterns were classified into six. The thermosensitive liquid crystal film can be a potential assessment tool to

early detect extravasation.

Key words: chemotherapy, extravasation, peripheral intravenous catheter, skin temperature

Introduction

Vesicant antineoplastic drugs can cause sub-

cutaneous tissue injury when they extravasate from

the vein1). Extravasation incidence is low

2), but some

anticancer drugs, even with few leakages, induce

ulceration or necrosis, which requires surgical treat-

ment and possibly results in a limited range of motion

in the joints at worst3)4)

. Thus, extravasation should be

early detected.

Conventionally, extravasation is detected by asses-

sing patients:symptoms (e. g., tingling, burning,

discomfort/pain, or swelling or redness at the

injection site) or problems in treatment (e.g., absence

of blood return, resistance on the plunger of the

syringe when administering a bolus drug, or interrup-

tion to the free flow of an infusion)5). This conventional

approach has some challenges. Nearly half of an

extravasation injury can be detected by patient:s

complaint of pain or discomfort6). However, subjective

― 89 ―

JNSE, 7 : 89〜98, 2020

Corresponding author: Hiromi Sanada Manuscript received: 30 September 2019

Department of Gerontological Nursing/Wound Care Management, Division of Health Sciences and Nursing, Graduate School of

Medicine, The University of Tokyo

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

E-mail: [email protected]

symptoms depend on the sensation of each patient,

and young children or people with impaired cognition

have communication difficulties of pain; thus, they are

considered risk factors7)8)

. Additionally, some treat-

ment strategies, such as using analgesics or anesthe-

sia, may negatively affect early detection due to

obtundation.

The change in skin-surface temperature has been

paid attention to because it does not influence

patients:subjective signs. Infiltration or extravasation

can be visualized macroscopically by thermography9)10)

.

One of our previous studies found a relationship

between a unique low-temperature distribution

pattern, that is,K fan at the puncture site, Lduring

anticancer drug administration and the onset of

induration at the next treatment day11)

. In the previous

study, temperature distribution images were shot

continuously by infrared thermography. An infrared

thermography is a noninvasive but expensive method

that requires enough space for taking images or skills

for focusing on the target area. If patients move their

catheterization sites, we have to rearrange the

position of the infrared thermographic camera. Hence,

taking images of multiple patients simultaneously is

difficult.

Thus, our research group had developed a thermo-

sensitive liquid crystal film (Figure 1) that can

visualize skin-surface temperature with a medical

device company. The film is placed directly on the

skin surface covered with a securement film. This

film-type thermography requires low cost, no space,

no skills for taking temperature distribution images,

and unconstrained patients:movement.

This pilot study aimed to confirm its usability for

clinical nurses, feasibility as a thermosensor, and

safety for the patients in the clinical setting, given that

some points are different from the ones in the

previous study. In the previous study, a noncontact

method was used, and skin-temperature data were

obtained. Additionally, nurses did not participate in

any skin-temperature data collection. We need to

confirm whether using the film can be added in the

nurses:daily routine, considering that chemotherapy

requires extremely tight schedule and complicated

therapy.

Method

The study design was cross-sectional.

1. Study setting and participants

This study was conducted in a chemotherapy room

with outpatients in a university hospital in Japan.

Patients participated only once in this study.

The inclusion criteria for patients were as follows:

aged over 19 years, undergoing chemotherapy

treatment using a peripheral intravenous catheter for

cancer, and received permission to participate in this

study from their physicians and clinical nurses.

Meanwhile, the exclusion criterion was the use of an

infusion warming device.

Clinical nurse participants were those who worked

in the chemotherapy room within the study period

and provided an informed consent. They were trained

by the researchers on how to use the film (i.e., how to

place it on the skin surface properly and how to peel it

safely). Data obtained between January 2018 and

March 2018 were collected.

2. Thermosensitive liquid crystal film

This film was developed by our laboratory and

Terumo Corporation (Tokyo, Japan). The size was 55×

90 mm. The temperature range was 30. 0℃-34. 0℃.

The color of the film changes with the skin-surface

temperature (Figure 2). This film can be repetitively

used, but it was used once in this study to rule out

infection. As necessary, nurses can observe the site

under the thermosensitive liquid crystal film after

peeling it during administration, and they can place it

back again. The adhesive strength condition of the

thermosensitive liquid crystal film can be verified as

follows: the skin-surface temperature could be

captured enough, and when it was peeled off carefully,

the securement dressing attached below remained

Journal of Nursing Science and Engineering（2020）

― 90 ―

Figure 1 Thermosensitive liquid crystal film during

infusion therapy

Low-temperature area is shown along the blood vessel.

intact. The experiment was repeated when the

abovementioned conditions were achieved; then, the

adhesive strength was decided. Its international

patent application number is WO2015/045371.

3. Analytical method for the qualitative analysis of

the low-temperature distribution patterns using the

thermosensitive liquid crystal film

One researcher who had an experience in thermo-

graphic analysis classified the low-temperature

distribution patterns. The researcher was blinded

about the details of the administered drugs as well as

the characteristics of participants and their symp-

toms. The researcher checked all pictures of the films

that changed colors with skin temperature and then

classified the pictures by using a previous study as a

reference8). In the previous study, low-temperature

distribution patterns obtained by infrared thermogra-

phy were classified into the following six patterns:

K no low-temperature area L(this pattern did not

feature a low-temperature area during the infusion),

K sharp line along the vein L(the shape of the

low-temperature area was similar to the sharp line

along the vein),Kbroad area from the veinL(a low-

temperature line was initially displayed that widened

from the vein during the infusion),Klarge area of the

external sideL(the entire external side of the arm was

cooled in patients catheterized at the wrist),Kcircle to

the line along the veinL(a circular low-temperature

area appeared at the catheter tip position; the circle

did not enlarge, and a low-temperature line some-

times appeared along the vein during infusion), and

Kfan at the puncture siteL(a fan-shaped low-temper-

ature area was observed at the puncture site). The

Kfan at puncture siteLpattern specifically predicted

the occurrence of induration compared with the other

patterns.

4. Procedure, survey items, and data source

1) Usability

In this study, usability was operationally defined as

the nurses:evaluation of the film in terms of placing

and peeling the film from the patients: skin and the

time and/or frequency of observation for the early

detection of extravasation during drug administra-

tion.

For the usability evaluation, the nurses were

questioned about the level of ease in placing and

peeling the film and the time and frequency of clinical

observations during drug administration.

During the procedure, a nurse or a physician

inserted a catheter into the patient to administer the

anticancer drugs; then, the nurse placed the thermo-

sensitive liquid crystal film on a securement film and

routinely started the chemotherapy. Using a question-

naire, a researcher interviewed the nurses regarding

the usability of the film application after finishing drug

administration. The nurses were also asked about

their years of clinical experience.

The questionnaire for nurses consisted of

closed-ended questions, the visual analog scale (VAS),

a three-grade evaluation, and open-ended questions.

We used the following open-ended question:K Did

you change your actions or feelings regarding the

patients because of changes in the temperature

distribution pattern? If you have changed your

actions or feelings regarding the patients, please

freely describe these changes.L

2）Feasibility

Feasibility was operationally defined as the film:s

ability to provide visualization of skin temperature

and to detect extravasation.

For the feasibility evaluation, we examined the

color change of the film, drug administration informa-

tion, catheterization site, drug type, and administra-

tion rates.

We collected data on the patients:characteristics

from their medical records, including information on

age, gender, body mass index (BMI), type of cancer,

and frequency of anticancer drug exposure. A

researcher photographed the film at repeatedly

observation during drug administration. We observed

the film at an interval time of roughly less than 30 min.


― 91 ―

Figure 2 Specification and usage of thermosensitive

liquid crystal film

3) Safety

We confirmed the safety of the film by assessing the

patients:symptoms or feedback just after using the

film. The patients were asked about their impression

and symptoms when using the film during drug

administration. Using a questionnaire, a researcher

interviewed the patients with regard to the safety of

film application after finishing drug administration.

The questionnaire for the patients consisted of

closed-ended questions, the VAS, and the following

open-ended question: Please let us know if you have

any impressions about the film.

Ethical consideration

An informed written consent was obtained from all

participants after receiving a written explanation of

the study. This study was conducted in accordance

with the Declaration of Helsinki, and the study

protocol was approved by the Research Ethics

Committee of the University of Tokyo (No: 11650).

Results

Eight of 10 nurses who worked in the chemother-

apy room participated in this study. All participating

nurses had over 2 years of clinical experience.

Meanwhile, 40 patients participated in the study

wherein 60% were female, the average age was 69.1

(SD 12.9) years, and the average BMI was 21.1 (SD 3.8)

(Table 1). All 40 patients with film application could

use the film continuously until completing their

anticancer drug administration without well-defined

extravasation. Median of the total drug administration

time was 111 min (IQR: 86-201).

1. Usability

Generally, 2 or 3 nurses were responsible for 1

patient. Nurses answered one questionnaire corres-

ponding to 1 patient. Thus, one questionnaire sheet

was filled out by multiple nurses.

During the clinical observations, 77.5% (31/40) and

80.0% (32/40) of the answers indicated that using the


― 92 ―

Table 1 Demographic characteristics and anticancer drugs (patient N=40)

Number, (％)/Mean±SD/Median (IQR1-IQR3)

Age (years) 69.4±12.9

Gender

Female 24 (60.0)

BMI N=39 21.2±3.8

Kind of cancer

Pancreatic cancer 14 (35.0)

Breast cancer 10 (25)

Stomach cancer 5 (12.5)

Lung cancer 2 (5.0)

Ovarian tumor 2 (5.0)

Skin cancer 2 (5.0)

Brain cancer 2 (5.0)

Others 3 (7.5)

Kinds of anticancer drug (viewpoints of tissue damage)

Vesicant 17 (42.5)

Irritant 5 (12.5)

Non-vesicant 18 (45.0)

Drug administration time (minutes) 111 (86-201)

Frequency of anticancer drug exposure 9.5 (5.25-14.0)

Catheterization site

Forearm 33 (82.5)

Cubital fossa 3 (7.5)

Hand 4 (10.0)

BMI: Body mass index

film did not affect the time and frequency of

observations, respectively. Other questions were

answered with the VAS. Median of the answers on

whether the location where the film should be placed

was easy to decide or not was 21 (Easiest=0). All

answers about the size, hardness, form, and color

obtained a median of around 50. Median of the

answers on whether the peeling of the film was easy

or not was 48 (Easy=0, Difficult=100), but the maximal

value was 90 (Table 2).

Some nurses described freely the usability of the

film. Nurses felt secured because they could visualize

the infusion flow along the vein in six cases. One of the

responses was,K I had a sense of security that the

drug solution is surely administered in the blood

vessel.LNurses also perceived that the film is

strongly adhesive in three cases. One response was,

KWhen I removed the thermosensitive liquid crystal

film, I had to pay attention not to remove the

securement film simultaneously, because I felt its

adhesion ability is quite strongL.

2. Feasibility

No evident extravasation features, such as occlu-

sion, redness, severe pain, absence of blood return, and

an interruption to the free flow of an infusion, were

noted. All patients completed their anticancer drug

administration without local adverse events.

Administration rates of anticancer drugs were 56-

500 ml/h. No cases without a low-temperature area

were found under anticancer drug administration of

more than 500 ml/h. In the current study, low-

temperature area distribution patterns were classified

into six types as follows:Kno low-temperature area,L

Ksharp line along the vein,LKbroad area from the vein,L

K circle to the line along the vein, LK fan at the

puncture site, LandK spot keeping. LOnlyK spot

keeping Lwas found as the new low-temperature

distribution pattern. Additionally,Klarge area of the

external side,Lwhich was observed in the previous

study, was not observed in the current study (Figure 3).


― 93 ―

Table 2 Nurses:usability evaluation of the thermo-sensitive liquid crystal film

QuestionsNumbers

respondedAnswers

Did you peel off the film for observation? 37 I did. 11/I did not. 26

How difficult was peeling the film off? 48 (0,90)＊1

Did observation time change for catheterization sites or skin by using the film? 40 Increase 9/No change 31/Decrease 0

Did frequency of observation change for catheterization sites or skin by using the film? 40 Increase 8/No change 32/Decrease 0

When you observe the catheterization sites, have you experienced as follow?

I was about to remove a catheter, with the thermo-sensitive liquid crystal film. 37 I was. 3/I was not. 18/I did not peel it off. 16

I was about to peel off the securement film, with the thermo-sensitive liquid crystal film. 38 I was. 0/I was not. 20/I did not peel it off. 18

Did you change your action or feeling against for the patients with the change of the temperature

distribution pattern?38 I did. 9/I did not. 29

About putting the thermo-sensitive liquid crystal film

When you decide location for putting the film on, was it easy to put?＊1 40 21 (0,68)

How did you think about the size?＊2 40 41 (0,60)

How did you think about the hardness?＊3 40 45 (0,59)

How did you think about the form?＊4 40 49.5 (0,60)

How did you think about color that the film shows?＊5 40 51 (0,60)

How did you feel about adhesive power of the film after putting it on?＊6 38 48 (5,57)

Evaluation of VAS was showed as median (minimum, max)

＊ 1: Easy=0, Difficult=100, ＊ 2: Large=0, Small=100, ＊ 3: Hard=0, Soft=100, ＊ 4: Good=0, Bad=100, ＊ 5: Deep=0, Light=100, ＊ 6: Strong=0, Weak=100


― 94 ―

Figure 3 Examples of low-temperature distribution pattern

The schema on the left, excluding theKspot keepingLpattern, are based from a previous

study using an infrared thermography.

3. Safety

Forty patients answered the questionnaire regard-

ing the thermosensitive liquid crystal film. All of them

responded that they did not mind using the film, and

they did not have any symptoms due to using the film,

such as itching, pain, cold or hot feeling, tightened

feeling, and other discomfort. The patients reported

their feelings of using the film during chemotherapy

and the visualization of their skin temperature. Two

patients experienced that a nurse peeled off the film,

observed the site under the film, and placed it back

during drug administration. These 2 patients

answered about their impression at that time using

the VAS (Feel secure=0, Feel anxious=100); one

patient answered 0, and another answered 50 (Table

3). In 11 cases, the nurses reported peeling the

thermosensitive liquid crystal film for observation

during drug administration; however, 9 of the 11

patients did not notice this.

One patient who had an extravasation experience

stated,K I had anxiety about extravasation recurr-

ence, but today, I had been relieved by this film

because the drug flow during anticancer administra-

tion can now be visualized.L

There was no epidermal peeling due to the use of

the thermo-sensitive liquid crystal film.

Discussion

In all 40 cases that were applied with the

thermosensitive liquid crystal film, the films were

continuously used until completing the anticancer

drug administration. Extravasation did not occur in

the participants. In addition, they did not complain

such as itching, pain, cold or hot feeling, tightened

feeling, and discomfort, when using such film.

Thermosensitive liquid crystal film can be used as a

new observation tool for extravasation detection in

clinical setting because additional time to treat the

film was considered acceptable according to data. In

such data, approximately 80% of nurses:answers

revealed that the time and frequency of observation

remained unchanged compared with those before

using the film, and most nurses could decide easily

where the film should be placed. The size, hardness,

shape, color and adhesive power of the film were

asked in bipolar. Medians for each of these ratings

were around 50, thus there was no clinical issue and it

was considered that there was no need to change the

specifications. Some nurses had an impression that the

film:s adhesion power was strong; however, we had

performed adhesive/remove test repeatedly, and we

confirmed that the adhesive strength that did not

affect the securement film and the skin at the

insertion site in the developing phase. Thus, we think

that the adhesive strength does not require modifica-

tion immediately. However, thorough education on

how to safely peel the film is essential because older

patients or other patients receiving some chemother-

apy have vulnerable skin.

The thermosensitive liquid crystal film may make


― 95 ―

Table 3 Patients:safety evaluation of the thermo-sensitive liquid crystal film

Questions Numbers responded Answers

Did you mind using the film? 40 I did. 0/I did not. 40

Did you feel any of the following symptoms?

Itching 40 Yes 0/No 40

Pain 40 Yes 0/No 40

Heat feeling 40 Yes 0/No 40

Cold feeling 40 Yes 0/No 40

Tightening sansation 40 Yes 0/No 40

Other discomfort 40 Yes 0/No 40

How did feel about being able to visualize skin temperature? 40 38 (0, 53)＊

How did feel about using the film in the area around the secured catheter? 40 20 (0, 52)＊

Did you have an experience with peeling off the film, and reapplying it? Yes 2/No 38

If you have the above experience, how did you feel? 2 25 (0, 50)＊

Evaluations of VAS shows as median (range)＊: Feel secure=0, Feel anxious=100

the nurses feel secured, considering that nurses had a

sense of security because they could visualize the

infusates flowing along the vein in six cases. Accord-

ing to one previous study, 83.4% of nurses reported

that they had experienced at least one undesirable

error while preparing or administering chemother-

apeutic drugs during their professional life, and

Kstress, tiredness, and burn-out syndromeLwas one

of the reasons of that error12)

. Current chemotherapy is

an extremely complex treatment due to using

multiple drugs, having various sequences of drug

administration, and requiring strict infusion time.

Furthermore, most anticancer drugs are highly

toxic13)

; thus, nurses must be sensitive to prevent

extravasation and occupational exposure14)

. Given the

abovementioned points, anticancer drug administra-

tion may lead to heavy stress to nurses, and reducing

nurses:stress is important. This pilot study suggested

that the thermosensitive liquid crystal film may help

reduce their stress.

In current study, the low-temperature distribution

patterns on the skin surface using the thermosensi-

tive liquid crystal film were classified into six patterns.

Most of the distribution patterns of skin-surface

temperature of the film were similar to those in our

previous study that used infrared thermography7)

(Table 4). When the administration rate was 500 ml/h

or more, all cases with low-temperature area were

confirmed. This condition is essential for the assess-

ment tool (film) to be used as an extravasation

detection device. Early detection of extravasation

during high-speed drug administration is the crucial

point to reduce tissue damage because large amounts

of leaked drugs may result in severe damage on the

subcutaneous tissue15)

.

Using this film may lead to patients:feeling of

security because according to their answers, the

maximum, median, and minimum values were 52, 20,

and 0, respectively, in the VAS (Feel security=0, Feel

anxiety=100). In other words, using this film could

provide a sense of security to patients during

anticancer administration and not only early detection

of extravasation. Especially, anticancer administration

may lead to stress for patients who had an extravasa-

tion experience. Visualization of anticancer flow can

make the patients feel secured.

This study has some limitations. We could not

confirm the feasibility of early extravasation detection

because sample size was small due to this is a pilot

study, possibly leading to such result. We could not

observe onset delayed extravasation symptoms such

as ulcer or induration, because this study was cross-

sectional study. Extrapolation of results requires

attention because this pilot study was conducted in a

chemotherapy room in outpatient service. Generally,

anticancer drug administration time in the outpatient

service is shorter than that in the inpatient ward, it

means that the using time of the thermosensitive

crystal liquid film in the outpatient service is shorter

than that in the inpatient ward. Thus, the usability

and safety of this film were unclear in the inpatient

ward.

In future studies, a sufficient number of patients,

longitudinal research and a different situation, such as

in the inpatient ward, are necessary.

Conclusion

The thermosensitive liquid crystal film was used in

40 patients undergoing anticancer treatment using a

peripheral intravenous catheter in a chemotherapy

room without adverse events. Most of the nurses:

answers indicated that the film did not influence the


― 96 ―

Table 4 Temperature distribution patterns

Results from preveous study using aninfrared thermography(n=74)

Results of this study using the thremo-sensitive liquid crystal film(n=40)

No low temperature area 14 (18.9%) 6 (15.0%)

Sharp line along vein 40 (54.1%) 16 (40.0%)

Broad area from vein 7 (9.5%) 5 (12.5%)

Circle to line along vein 2 (2.7%) 3 (7.5%)

Fan at puncture site 7 (9.5%) 2 (5.0%)

Large area of external side 4 (5.4%) 0 (0.0%)

Spot keeping − 8 (20.0%)

time and frequency of observing the catheterization

sites. Therefore, the usability and safety of the film

were confirmed acceptable in the clinical setting. Six

types of temperature distribution patterns were

observed using the thermosensitive liquid crystal film.

However, extravasation did not occur; thus, the film:s

feasibility still needs to be confirmed. A larger sample

size and longitudinal study is required in future

studies to verify the effectiveness of the thermosensi-

tive liquid crystal film in early detecting extravasa-

tion.

Conflict of interest

This study was a part of the joint research of a

peripheral intravenous catheter management with

Terumo Co. Mari Abe-Doi and Ryoko Murayama

belong to the laboratory supported by Terumo Co.

Hidenori Tanabe is an employee of Terumo Co. The

thermosensitive liquid crystal films were provided by

Terumo Co.

Funding

This work was supported by JSPS KAKENHI

Grant Number 17H06645 and The Yasuda Medical

Foundation.

Reference

1) Wengström Y, Margulies A．European Oncology

Nursing Society Task Force. European Oncology

Nursing Society extravasation guidelines. Eur J Oncol

Nurs 12: 357-361, 2008.

2) Jackson-Rose J, Del Monte J, Groman A, et al.

Chemotherapy Extravasation: Establishing a National

Benchmark for Incidence Among Cancer Centers.

Clin J Oncol Nurs 21: 438-445, 2017.

3) U. S. Department of Health and Human Services.

National Institutes of Health National Cancer Institute

Common Terminology Criteria for Adverse Events

(CTCAE) Version 5.0, Page 42 (2017/11). 2019/9/17,

［https://ctep.cancer.gov/protocolDevelopment/elec-

tronic_applications/docs/CTCAE_v5_Quick_Refer-

ence_8.5x11.pdf］

4) Wickham R, Engelking C, Sauerland C, et al. Vesicant

extravasation part II: Evidence-based management

and continuing controversies. Oncol Nurs Forum 33:

1143-1150, 2006.

5) J A Pérez Fidalgo, L García Fabregat, A Cervantes, et

al. Management of Chemotherapy Extravasation:

ESMO Clinical Practice Guidelines. Ann Oncol 23:

vii167-vii173, 2012.

6) Sakaida E, Sekine I, Iwasawa S, et al. Incidence, risk

factors and treatment outcomes of extravasation of

cytotoxic agents in an outpatient chemotherapy

clinic. Jpn J Clin Oncol 44: 168-171, 2014.

7) Onesti MG, Carella S, Fioramonti P, et al. Chemother-

apy Extravasation Management: 21-Year Experi-

ence. Ann Plast Surg 79: 450-457，2017.

8) Schulmeister L. Extravasation management: clinical

update. Semin Oncol Nurs 27: 82-90, 2011.

9) Matsui Y, Murayama R, Tanabe H, et al. Evaluation of

the Predictive validity of thermography in identifying

extravasation with intravenous chemotherapy infu-

sions. J Infus Nurs 40: 367-374, 2017.

10) Oya M, Takahashi T, Tanabe H, et al. Low-tempera-

ture infiltration identified using infrared thermogra-

phy in patients with subcutaneous edema revealed

ultrasonographically: A case report. Drug Discov

Ther 10: 117-122, 2016.

11) Oya M, Murayama R, Oe M, et al. Continuous

thermographic observation may predict extravasa-

tion in chemotherapy-treated patients. Eur J Oncol

Nurs 28: 56-61, 2017.

12) Ulas A, Silay K, Akinci S, et al. Medication errors in

chemotherapy preparation and administration: a

survey conducted among oncology nurses in Turkey.

Asian Pac J Cancer Prev 16: 1699-1705, 2015.

13) Pluschnig U, Haslik W, Bayer G, et al. Outcome of

chemotherapy extravasation in a large patient series

using a standardised management protocol. Support

Care Cancer 23: 1741-1748, 2015.

14) Graeve CU, McGovern PM, Alexander B, et al.

Occupational Exposure to Antineoplastic Agents: An

Analysis of Health Care Workers and Their Environ-

ments. Workplace Health Saf 65: 9-20, 2017.

15) Darcy Doellman, Lynn Hadaway, Leigh Bowe-Ged-

des, et al. Infiltration and extravasation: update on

prevention and management. J Infus Nurs 32:

203-211, 2009.


― 97 ―

原著

抗がん剤の血管外漏出早期発見のための新しい液晶感温フィルム

の使用感，実現可能性，安全性における臨床評価：

パイロットスタディ

阿部麻里.）

・村山陵子.）/）

・田邊秀憲0）

・上山恵三子1）

小見山智恵子1）

・松井優子2）

・真田弘美/）3）

.）東京大学大学院医学系研究科社会連携講座アドバンストナーシングテクノロジー/）東京大学医学部附属グローバルナーシングリサーチセンター

0）テルモ株式会社研究開発部門1）東京大学医学部附属病院看護部

2）公立小松大学保健医療学部看護学科3）東京大学大学院医学系研究科健康科学・看護学専攻老年看護学／創傷看護学分野

要旨

抗がん剤の血管外漏出の早期発見は重要であるが，そのアセスメントはむずかしく，客観的手法が求められている．

そこで液体貯留が皮膚表面温度の低下をもたらすことから，非侵襲的かつ持続使用可能で安全な血管外漏出アセスメン

トツールとして，液晶感温フィルムを開発した．研究目的は，開発したフィルムの使用感，安全性，皮膚表面温度の可

視化における実現可能性を確認することである．患者 40名と看護師 8名を対象とした．明らかな血管外漏出はなかっ

た．使用後の調査において，患者は全員がフィルムを使用してもよいと答え，かゆみなどの不快感があったものはいな

かった．看護師は，感温フィルムをカテーテル固定用フィルムの上に貼付し，通常通り薬剤投与を行い，使用感を感温

フィルム 1枚ごとに評価した．看護師の回答の 80％において観察の頻度は変わらなかったことから，業務負担への影響

は少ないと考えられた．カメラで記録された温度分布は 6つのパターンに分類された．以上より，血管外漏出アセスメ

ントツールとしての実現可能性が示唆された．

キーワード：化学療法，血管外漏出，末梢静脈カテーテル，皮膚表面温度

キーメッセージ

�．今回の研究は看護・介護のどのような問題をテーマにしているのか？

研究を行うきっかけとなったことはどのようなことか？

抗がん剤静脈投与における血管外漏出の早期発見をテーマとしている．血管外漏出により重篤な障害を起こす可能

性のある抗がん剤治療を，患者も看護師も安心して治療を行う方法はないかと考えた．

�．この研究成果が看護・介護にどのように貢献できるのか？あるいは，将来的に貢献できることは何か？

視診・触診・問診で行われてきた血管外漏出のアセスメントにカテーテル留置部周囲の皮膚温度という新たな方法

が加わる可能性が示唆された．将来的には，抗がん剤投与中の異常の早期発見に貢献できる．

�．今後どのような技術が必要になるのか？

持続的にモニタリングしている温度変化により発見される異常をすみやかに医療従事者へ知らせるような技術開発

が必要である．


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