Research

OR I G I N A L AR T I C L E

The impact of two distinct endotracheal tube fixation on the formation of pressure ulcer in the intensive care unit: A randomised controlled trial

Alev Genc1 | Tulin Yildiz2

1Department of Surgical Diseases Nursing, Bahcesehir University, Institute of Health Sciences, Istanbul, Turkey 2Department of Surgical Diseases Nursing, Tekirdag Namık Kemal University, Institute of Health Sciences, Tekirdag, Turkey

Correspondence Tulin Yildiz, RN PhD, Assoc. Prof., Tekirdag Namık Kemal University, Institute of Health Sciences, Department of Surgical Diseases Nursing, Tekirdag, Turkey. Email: [email protected]

Abstract

The most common pressure ulcer associated with medical devices in the ICU is

pressure injury associated with the endotracheal tube. We aimed to scrutinise the

effects of two different techniques of endotracheal tube securement used in the

ICU on the occurrence of pressure ulcers. This randomised clinical trial was con-

ducted in 60 patients, 30 of which were intervention and 30 experimental,

admittedin the ICU of a training and research hospitaldata were collected using the

descriptive and clinical characteristics from the Braden Scale for predicting Pressure

Sore Risk, the Pressure Ulcer Scale for healing, The International Staging System

for Pressure Injuries and the Eilers Oral Assessment Guide. Based on the Braden

Scale scores of the patients, we found that 98.3% of the cases were in the high-risk

group before and after the intervention. We also found that the recovery was higher

among patients in whom the bandage fixation method was applied compared to

those in whom the fixation was done with an endotracheal tube holder.

KEYWORD S

endotracheal tube holder, intensive care, nursing care, pressure ulcer

Key Messages • regarding the fixation of an endotracheal tube, it was found out that ban-

dage fixation was better than the endotracheal tube holder technique in terms of both the pressure sore risk score difference and the tendency to fall, dislocate or remain stable, according to the Braden Scale for Predicting Pres- sure Sore Risk assessment results of the first and fourth days

• it was determined that the use of vasopressors, as well as low total protein, serum albumin, and haemoglobin levels, increased the formation of oral pressure injuries in the fixation of the endotracheal tube

1 | INTRODUCTION

An oral pressure ulcer is a localised injury to the oral mucosa and surrounding skin and/or underlying tissue

due to the pressure and laceration caused by a medical instrument.1 Various studies have revealed that the most common pressure injury among medical-device-related pressure ulcers is the oral pressure ulcer due to which

Received: 17 December 2021 Revised: 6 January 2022 Accepted: 8 January 2022

DOI: 10.1111/iwj.13757

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any

medium, provided the original work is properly cited and is not used for commercial purposes.

© 2022 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.

1594 Int Wound J. 2022;19:1594–1603.wileyonlinelibrary.com/journal/iwj

patients experience pain, oral infection and deterioration in comfort (2. 3. 4). The skin might be an indicator of early pressure injury. Skin assessment is of great impor- tance in preventing pressure ulcers because the skin con- dition has been identified as a significant risk factor for the occurrence of pressure ulcers. It is crucial to conduct studies to investigate medical device-related pressure ulcers during health care services to identify those ulcers associated with the medical device and to determine the risk factors and use safe materials in the prevention of those device-related pressure ulcers.2 In this regard, using reliable endotracheal tube (ET) fixation can be helpful in ensuring patient comfort.

In the ICU, support is provided for organ dysfunction, notably for the cardiovascular system and respiratory sys- tem, the hemodynamic status of the patient can be moni- toredcontinuously and patients who cannot meet their personal needs are to be provided with treatment and care. The use of technological instruments when deliver- ing this treatment and care distinguishes the ICU from other units and indicates the desire to provide profes- sional care to the most critically ill patients in the ICU.3-5

Individuals who stay in the ICU (ICU) for a long time And who are connected to a ventilator immobile are faced with negative risk factors due to prolonged hospital stay, diagnosis, and treatment processes. One of the most con- siderable risk factors is pressure ulcer.6 Medical devices are crucial components in providing care for critically ill patients; however, they are increasingly considered as a potential cause of pressure ulcers.7 Medical device-related pressure ulcers can be caused by localised injury to the epidermis and/or underlying tissue due to the constant pressure of the device made of hard and rigid material.7,8

The most common pressure ulcer due to medical devices is the ET pressure injury.8 The device that is attached by nasal or oral route to patients who need mechanical ventilator support in the ICU is called an “ET” and the procedure is termed intubation.9 Maintain- ing intubation is the priority to save the lives of mechani- cally ventilated patients.10 So, unplanned extubation or accidental movement of ET leads to life-threatening prob- lems.8 This happens also during reintubation following unplanned extubation, The laryngoscope may traumatise the mouth and pharynx and ET may traumatise the vocal cords and trachea, causing facial and oral mucosal pressure ulcers and increasing the likelihood of ventilator-related pneumonia, duration of stay in the ICU, duration of hospitalisation. and the number of days under mechanical ventilation.10-12

The primary way to prevent unwanted extubation is to properly securethe ET.11 In order to stabilise ET, methods such as the use of adhesive tape, bandage. and endotra- cheal tube holder (ETT) are employed by considering such

factors for the ease of use, cost, patient comfort and the effective use of time7,12 . Yet, these methods used in the fix- ation of ET may cause pressure ulcers related to endotra- cheal intubation around the oral mucosa and lips.13

Intensive care nurses who are critical members of the interdisciplinary teamAre supposed to undertake the task of identifying possible risk factors in the ICU and take necessary measures to prevent and/or reduce the occur- rence of such risk factors. Duties and responsibilities of the intensive care nurses include management of ET in the ICU, deciding on the appropriate ET fixation method for the intubated patient, fixing of ET safely, assessing the effects of ET on pressure ulcer risk factors, taking the necessary measures to prevent the occurrence of ET- related infection and maintaining the materials used in the fixation.9 Remarkably, the studies investigating whether ET securement methods, which have been rev- ealed through evidence-based practices used in nursing care have a role in the formation of oral pressure ulcers are quite limited. In this randomised controlled trial, we aimed to scrutinise the effects of two different endotra- cheal tube fixation techniques used in the ICU on the for- mation of pressure ulcers.

2 | MATERIALS AND METHODS

2.1 | Patients and methods

The study was conducted on a sample of 60 patients, 30 of whom were interventions and 30 trials, in the anaesthesia and reanimation ICU of a training and research hospital between July and November 2020, in a randomised controlled and experimental design. Within the limitations of nursing competency, in the study, data were collected using the descriptive and clinical charac- teristics form. The Braden Scale for predicting Pressure Sore Risk. The Pressure Ulcer Scale for healing (PUSH), International Staging System for Pressure Injuries and the Eilers' Oral Assessment Guide.

2.2 | Sample size and randomization

The power analysis of the sample was performed using the G*Power (3.1) computer program [8]. Using the means and standard deviations in Kim et al and Hampson et al,7,8 the power analysis indicated that each group should comprise at least 30 patients. A total sample size of 60 patients should be adequate to detect the medium effects (d = 0.50) with a power of 80% using at- test between means with alpha at 0.05. Hence. this study was completed with 60 patients. The 106 patients included

GENC AND YILDIZ 1595

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense

in this study were randomly assigned to two groups by a person other than the researchers and both groups were given a nickname. For randomization, software was used to generate random numbers (from 1 to 60) (http://www. randomizer.org/form.htm). Both researchers and the inten- sive care nurses blinded to the group assignment. The study procedure followed the CONSORT flow diagram (see Figure 1).

2.3 | Inclusion criteria for research

Patients who were aged between 18 and 65 years were on orotracheal intubated, had no face and neck trauma, hadno

burns on the face, had no oral pressure ulcers, were con- nected to a mechanical ventilator, had no diabetes and gave verbal and written consent through their relatives to be involved in the study were also included in the study.

2.4 | ETHICS STATEMENT

Ethics committee approval was obtained from the “Clini- cal Research Ethical Committee of Marmara University Medical Faculty” and research permission was obtained from the “Istanbul Provincial Health Directorat” and written consent was obtained from the relatives of all patients for their patients to be included in the study.

Research population (n=220)

Those who were not included in the study (n=160)

1. Those who were not connected to a mechanical ventilator

(n=35)

2. Those who aged over 65 years (n=40)

3. Those who had Diabetes Mellitus (n=35)

4. Deceased (n=32)

5. Those from whom verbal and written consent could not be

obtained (n=18)Obtaining verbal and written consent

(n=60)

Sample (n=60)

Randomization of the sample (n=60)

Intervention group (n=30) Control group (n=30)

1. Administration of the Eilers Oral Assessment Guide (n=30)

2. Administration of the Braden Scale for Predicting Pressure Sore Risk

(n=30)

3. Administration of the introductory clinical characteristics form (n=30)

4. Performing the fixation method (n=30)

1. Administration of the Eilers Oral Assessment Guide (n=30)

2. Administration of the Braden Scale for Predicting Pressure Sore Risk (n=30)

3. Administration of the introductory clinical characteristics form (n=30)

4. Performing the fixation method (n=30)

1. Repositioning the tube every 4 hours (n=30)

2. Changing the fixation method every 24 hours (n=30)

3. Follow-up for 4 days (n=30)

Presence of pressure ulcer formation (n=30) Presence of pressure ulcer formation (n=30)

Yes (n=29) No (n=1) Yes (n=26) No (n=4)

1. Administration of the International Staging System

for Pressure Injuries (n=29)

2. Administration of the Pressure Ulcer Scale for

Healing (n=29)

3. Administration of the Braden Scale for Predicting

Pressure Sore Risk (n=29)

1. Administration of the International Staging

System for Pressure Injuries (n=26)

2. Administration of the Pressure Ulcer Scale for

Healing (n=26)

3. Administration of the Braden Scale for Predicting

Pressure Sore Risk (n=26)

Analysis (n=60)

1. Repositioning the tube every 4 hours (n=30)

2. Changing the fixation method every 24 hours (n=30)

3. Follow-up for 4 days (n=30)

FIGURE 1 CONSORT flow diagram

1596 GENC AND YILDIZ

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense

2.5 | Data collection

The 60 patients constituting the sample were divided into two groups using the software that generated the random numbers (http://www.randomizer.org/form.htm). In line with the objective of the research, The groups were labelled as group A and group B and one of the two dif- ferent endotracheal tube fixation methods was applied to the patients in each group. On the first day of the study, the oral mucosa of both groups was evaluated with the Eilers Oral Assessment Guide. Moreover, the pressure ulcer risk assessment of the patients in both groups was done using the Braden Scale for predicting Pressure Sore Risk. The demographic and medical information of the patients were collected using the descriptive and clinical characteristics form. The patients in both groups were followed up for 4 days in terms of oral pressure ulcers from the day they were intubated. During this period, the tube fixation of both groups was renewed every 24 hours and the tube was repositioned every 4 hours. At the end of the 4th day, the wound evaluation of the patients who developed pressure ulcers was made with the Interna- tional Staging System for Pressure Injuries and the Pres- sure Ulcer Scale for healing.7,14

2.5.1 | Introductory and clinical characteristics form

The Demographic characteristics and medical informa- tion of the patient were included in this form.

2.5.2 | The Braden scale for predicting pressure sore risk

The Braden Pressure Sore risk Assessment scale was developed by Nancy Bergstrom and Barbara Braden in 1985 and the Turkish validity and reliability test of the scale was conducted by Oguz and Olgun (1997).15,16 It involves 19 risk assessments and 6 sub-dimensions (sen- sory perception. moisture activity, mobility, nutrition, friction and shear). These risk factors are evaluated by nurses and scored between 6 and 23 points.

2.5.3 | The pressure ulcer scale for healing

The scale used to evaluate the healing process of the pres- sure wound consists of three sub-dimensions: surface area, amount of exudate and tissue type. The total score of the scale ranges from 0 to 17. An increase in the total

score indicates the severity of the pressure ulcer (https:// www.yoihd.org.tr/).17

2.5.4 | International staging system for pressure injuries

The clinical classification of pressure ulcers has been made by the international NPUAP-EPUAP pressure sore staging system (https://www.yoihd.org.tr/).17

2.5.5 | Eiler's oral assessment guide

It was developed by Eilers in 1988. The Eilers oral assess- ment guide enables the evaluation of the factors of voice, swallowing, lips, mucous membranes, tongue. Gingiva,teeth and saliva, voice and swallowing factors were excluded and the lips, mucous membranes, tongue, teeth,. gingiva and saliva were evaluated with Eiler's oral Assessment Guide via the inspection technique and +7 points were added to the total score as the patient was intubated after the evaluation. The total score provide information about the oral cavity health.18

2.6 | Data analysis

The IBM SPSS 22.0 package program was used while evaluat- ing the data of the research. The normality distribution evalu- ation of the data was first performed with the Kolmogorov– Smirnov test. It was found that there was no normal distribu- tion between the scales used and non-parametric tests were used in the analysis. In the difference analysis, Chi-square, Fisher's exact test and likelihood tests (χ2) were used to com- pare the variables in which both sides had categorical charac- teristics. The Mann Whitney U and Wilcoxon signed rank tests were used to compare the variables with categorical parameters and the variables with numerical data. Signifi- cance was evaluated at the P< .05 level.

3 | RESULTS

The mean age of the patients included in the study was 51.03 ± 10.29, the majority of whom were males and with chronic diseases. The most common chronic disease in the patients was hypertension. Regarding smoking status, more than half (55%) of them were smokers. The mean number of days of the intubation of patients (n = 60) included in the study during their stay in the ICU was determined to be 1.15 ± 0.44 (Table 1).

GENC AND YILDIZ 1597

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense

Considering the ET fixation methods, a significant difference was found between the patients with and with- out oral pressure ulcers in terms of vasopressor drug use in those with bandages (χ2:13.929; P = .01). It was found that patients with oral pressure ulcers were using vaso- pressor medications. A significant difference was found between the patients with and without oral pressure ulcers regarding the nutritional risk score in whom the bandage method was applied for the fixation of ET (χ2: 15.189; P = .04). Patients with oral pressure ulcers had a higher risk in terms of nutritional risk score, whereas most of the patients without oral pressure ulcers had a lower nutritional risk score. Furthermore, when the total protein, serum albumin, and haemoglobin levels of the patients who were applied bandages for the fixation of ET were analysed, a significant difference was found between the patients with and without oral pressure ulcers (χ2: 12.692; P = .03; χ2: 15.165; P = .03; χ2: 6.887; P = .03) (Table 2).

A significant difference was foundwhen the endotra- cheal tube fixation method was compared based on the Braden Scale for predicting Pressure Sore Risk assess- ment results of the first and fourth day of the study (z = �4.878; P = .000). A decrease of 1.20 points was found between the Braden Pressure Ulcer Risk Assess- ment Scale score evaluated on the first day and the fourth day in the fixation of ET with the ETT method. More- over, it was found that the scores of only two patients remained the same, whereas, the scores of 28 patients decreased. Thus, the risk of pressure ulcers increased. A significant difference was found, when the results on the first day and the fourth day were compared in the fixa- tion of ET by the bandage method (z = �3.622; P = .000). There was a decrease of 1.06 points between the Braden pressure ulcer risk assessment scale score evaluated on the first day of the study and the score eval- uated on the fourth day of the study. Besides, while the scores of only seven patients remained the same, the

TABLE 1 Information on the descriptive characteristics of patients

Characteristics n Percentage (%)

Sex

Female 26 43.3

Male 34 56.7

Total 60 100.0

Presence of chronic disease

Yes 36 60.0

No 24 40.0

Total 60 100.0

If yes. Which diseases?

Hypertension 24 48.0

Chronic obstructive pulmonary disease

1 2.0

Coronary artery disease 19 38.0

Cancer 2 4.0

Other 4 8.0

Total 50 100.0

Smoking status

Yes 33 55.0

No 27 45.0

Total 60 100.0

Characteristics n X̄±σ Minimum Maximum

The duration for being intubated in the ICU 60 1.15 ± 0.44 1.00 3.00

Age (years) 60 51.03 ± 10.29 18.00 63.00

Weight (kg) 60 77.80 ± 9.09 150.00 182.00

Height (cm) 60 170.21 ± 9.35 60.00 95.00

BMI (kg/m 2) 60 26.85 ± 2.46 20.76 35.16

1598 GENC AND YILDIZ

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense

TABLE 2 Pressure ulcer formation status of patients who underwent two different endotracheal tube fixation methods according to

their introductory and clinical characteristics

Characteristics

Bandage Endotracheal tube holder

Pressure ulcer formation

χ2 P

Pressure ulcer formation

χ2 P

Present Absent Present Absent

n % n % n % n %

Sex

Female 12 46.2 3 75.0 1.154 .299 11 37.9 0 0.0 0.599 .633

Male 14 53.8 1 25.0 18 62.1 1 100.0

Intensive care hospitalisation diagnosis

Internal medicine 5 19.2 0 0.0 5.052 .168 11 37.9 0 0.0 1.564 .668

Chest Diseases 12 46.2 1 25.0 4 13.8 0 0.0

General Surgery 6 23.1 3 75.0 13 44.8 1 100.0

Cardiology 3 11.5 0 0.0 1 3.4 0 0.0

Presence of chronic disease

Yes 17 65.4 1 25.0 2.356 .163 17 58.6 1 100.0 0.690 .600

No 9 34.6 3 75.0 12 41.4 0 0.0

Smoking

Yes 15 57.7 2 50.0 0.084 .591 15 51.7 1 100.0 0.905 .533

No 14 42.3 2 50.0 14 48.3 0 0.0

Use of steroid medication

Yes 19 73.1 2 50.0 0.879 .345 20 69.0 1 100.0 0.443 .700

No 7 26.9 2 50.0 9 31.0 0 0.0

Vasopressor drug use

Yes 26 100.0 2 50.0 13.929 .01 29 100.0 1 100.0 — —

No 0 0.0 2 50.0 0 0.0 0 0.0

Use of sedation

Yes 25 96.2 3 75.0 2.493 .252 29 100.0 1 100.0 — —

No 1 3.8 1 25.0 0 0.0 0 0.0

Nutritional Risk Scoring

Low Risk (<0–4) 1 3.8 3 75.0 15.189 .04 7 24.1 0 0.0 0.315 .767

High Risk (≥5–9) 25 96.2 1 25.0 22 75.9 1 100.0

Endotracheal Tube Number

7 1 3.8 0 0.0 1.262 .868 0 0.0 0 0.0 1.718 .424

7.5 5 19.2 1 25.0 9 31.0 0 0.0

8 8 30.8 2 50.0 8 27.6 0 0.0

8.5 11 42.3 1 25.0 12 41.4 1 100.0

9 1 3.8 0 0.0 0 0.0 0 0.0

Glasgow coma scale

Stupor 5 19.2 2 50.0 2.181 .336 0 0.0 0 0.0 0.074 .933

Pericoma 3 11.5 0 0.0 2 6.9 0 0.0

Coma 18 69.2 2 50.0 27 93.1 1 100.0

Total protein level

<5.4 g/dL 22 84.6 0 0.0 12.692 .03 21 72.4 0 0.0 2.414 .300

>5.4 g/dL 4 15.4 4 100.0 8 27.6 0 100.0

(Continues)

GENC AND YILDIZ 1599

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense

score of one patient was found to be high, showing a pos- itive trend. However, 22 of them were found to have decreased scores, thus increasing the risk of pressure ulcers. When two methods were compared, it was found that the bandage method was better than the ETT method in terms of both the pressure ulcer risk score difference and the tendency to fall, dislocate or remain stable (Table 3).

When the results of the endotracheal tube fixation method and the Pressure Ulcer Scale for Healing were compared, a significant difference was found between the performed methods (U: �4.721; P = .000 < .05). The Pressure Ulcer Scale for the healing score of the patients

who were applied bandage in the fixation of ET was determined to be lower than the score of the patients who were applied with ETT in the fixation of ET. Hence, it was concluded that the bandage fixation method showed more improvement than the ETT fixation method. When the ET fixation method and the pressure ulcer scale for healing sub-dimension were considered (tissue surface area and tissue type,. which are sub- dimensions of the pressure wound healing assessment scale), results were compared, the amount of exudate, which is the sub-dimension of the Pressure Ulcer Scale for Healing, was not taken into consideration as the pres- ence of exudate was not detected in the pressure ulcer. A

TABLE 2 (Continued)

Characteristics

Bandage Endotracheal tube holder

Pressure ulcer formation

χ2 P

Pressure ulcer formation

χ2 P

Present Absent Present Absent

n % n % n % n %

Serum albumin level

<3.5 g/dL 23 88.5 0 0.0 15.165 .01 21 72.4 0 0.0 2.414 .300

>3.5 g/dL 3 11.5 4 100.0 8 27.6 0 100.0

Haemoglobin level

<12 g/dL 22 84.6 1 25.0 6.887 .03 23 79.3 0 0.0 3.399 .233

>12 g/dL 4 15.4 3 75.0 6 20.7 1 100.0

ASA Classification

ASA II 0 0.0 0 0.0 3.077 0.112

1 3.4 0 0.0 1.564 .458

ASA III 14 53.8 4 100.0 13 44.8 1 100.0

ASA IV 12 46.2 0 0.0 15 51.7 0 0.0

APACHE II Score

0–10 0 0.0 0 0.0 2.518 0.284

1 3.4 0 0.0 2.740 .254

10–20 4 15.4 2 50.0 7 24.1 1 100.0

20–35 20 76.9 2 50.0 21 72.4 0 0.0

≥35 2 7.7 0 0.0 0 0.0 0 0.0

Note: P < 0.01. Bold values indicate that they are statistically significant.

TABLE 3 Comparison of the first and fourth day according to the score of the Braden scale for predicting pressure sore risk

Method used n Braden pressure ulcer risk measures Tendency z P

Endotracheal tube holder 30 Measurement 1: 9.10 ± 1.21 Negative: 28 �4878 .000*

30 Measurement 2: 7.90 ± 1.06 Positive: 0

M2 - M1 Difference: 1.20 Equal: 2

Bandage 30 Measurement 1: 9.76 ± 1.40 Negative: 22 �3622 .000*

30 Measurement 2: 8.70 ± 1.53 Positive: 1

M2 - M1 Difference: 1.06 Equal: 7

*P < 0.001.

1600 GENC AND YILDIZ

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense

significant difference was found between the applied methods when the ET fixation method was applied to the patient and the surface area of pressure ulcer were com- pared (u: �4.812; P = .000 < .05). The size of the pressure ulcer due to ET fixation with ETT was significantly greater than the size of the pressure ulcer that resulted from ET fixation with gauze. No significant difference was found between the methods when the ET fixation method applied to the patient and the tissue type of the pressure ulcer were compared (P > .05) (Table 4).

4 | DISCUSSION

Individual and clinical characteristics are among the most important risk factors in the formation of pressure ulcers.19 From this study, we found that the majority of the participants were male and had a chronic disease; they also smoked. Hanonu et al revealed, in their pro- spective descriptive study, that advanced age, obesity and risk factors due to chronic disease impact the formation of medical-device-related pressure ulcers.

Malnutrition, loss of emotional perception and lack of movement, hypoalbuminemia, anaemia, vasopressor therapy, steroid therapy.and sedative medication are the important risk factors in the formation of pressure ulcers.7,8,10,13,19,20 In this study, it was found that most of the patients had a high-risk nutritional risk score and were in the coma, based on the Glasgow Coma Scale. Moreover, it was found that the majority of the patients who received steroid and vasopressor medication were sedated and had low total protein and albumin levels. In our study, a significant difference was found between the formation of low total protein, serum albumin and haemoglobin levels in patients in whom ET fixation was performed with the bandage method, whereas, there was no difference between the formation of oral pressure ulcers in patients to whom ET fixation was applied with

the ETT method. Kim et al8 found a significant difference between total protein level and oral pressure ulcer forma- tion (P = .03). Karsli et al21 found a significant difference between total protein level and stage of ulcer in their study, whereas, Hampson et al found no significant dif- ference between serum albumin level and oral pressure ulcer formation. However, Kwon et al determined a sig- nificant difference between oral pressure ulcer formation and serum albumin levels.7,10 In addition to that, Kim et al8 study supported ourobservation . In our study, a significant difference was found between the patients with and without oral pressure ulcers when the serum albumin level was evaluated in patients in whom ET fixa- tion was performed using the bandage method. The serum albumin level was determined to be below 3.5 g/dL in 88.5% of patients with oral pressure ulcers.

Receiving steroid medication might increase the risk of medical device-related pressure ulcers.14 In the study of Hampson et al,7 no significant difference was found between the use of steroid drugs and the formation of oral pressure ulcers. On the other hand, in the study of Kwon et al,10 found a significant difference between the forma- tion of oral pressure ulcers and the use of steroid medica- tion. However, in our study, when the steroid drug use status was analysed in patients who were subjected to both ET fixation methods, no significant difference was found between patients with and without oral pressure ulcers.

Hanonu et al14 revealed that as the haemoglobin level decreases, the risk of developing a medical device-related pressure ulcer is 1.17 times higher than in a patient with a normal haemoglobin level. Kim et al8 detected a signifi- cant difference between oral pressure ulcer formation and haemoglobin level. Likewise, in our study, when the haemoglobin level was examined in patients who under- went endotracheal tube fixation with a bandage, a signifi- cant difference was found between patients with oral pressure ulcers and those without. It was found that the haemoglobin level of the patients with oral pressure ulcers

TABLE 4 Comparison of

endotracheal tube fixation method and

The Pressure Ulcer Scale for Healing

sub-dimension (tissue surface area and

tissue type) results

n Median x̄ ± σ U P

The pressure ulcer scale for healing results

Endotracheal tube holder 29 6 5.86 ± 1.27 �4721 0000*

Bandage 26 4 3,84 ± 1,12

Tissue surface area (Length � Width)

Endotracheal tube holder 29 5 5,12 ± 1,05 �4812 0000*

Bandage 26 3 3,30 ± 1,08

Tissue Type

Endotracheal tube holder 29 1 0,88 ± 0,33 �1595 0.111

Bandage 26 1 0,70 ± 0,46

*Mann Whitney U, P < .05.

GENC AND YILDIZ 1601

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense

remained below 12 g/dL, while it was above 12 g/dL in the patients without oral pressure ulcers.

It has been suggested in the literature that the force applied by ETT on the face during head-up and rotation is nearly 260 mmHg/cm and when the pressure distrib- uted to the oral mucosa exceeds 32 mmHg, it might result in vascular occlusion and oral pressure ulcers.22

Zaratkiewicz et al,23 on the other hand, used a bite block in the first stage and two different ETTs in the second and third stages of the study in their study, which started with the retrospective stage and carried out the second and third stages with the prospective interventional study method They found that the incidence of pressure ulcer development due to ET was reduced from 1.25% to 0.2%. Hanonu et al,14 in their study, found that the risk of med- ical device-related pressure ulcer formation increased 1.81 times as the Braden Scale for predicting Pressure Sore Risk score shifted from low risk to high risk and that there was a significant difference between the Braden Scale for predicting Pressure Sore Risk score and the risk of medical-device-related pressure ulcers. In the study, it was found that the bandage method was better than the ETT method in terms of both the pressure ulcer risk score difference and the tendency to fall. Dislocate or remain fixed.

The Pressure Ulcer Scale for Healing developed by NPUAP enables assessment of the condition of the wound over time. Zeigler et al24 suggested, in their study, that the Pressure Ulcer Scale for Healing supports the clinical decision-making process of the nurse during the evaluation, follow-up and recovery process of the pres- sure ulcer. In the study, the Pressure Ulcer Healing Assessment score of the patients who were applied ban- dage in the fixation of ET was found to be lower than the score of the patients in whom the fixation was performed via ETT. Hence, it was concluded that the bandage fixa- tion method showed more improvement than the ETT fixation method. To eliminate oral pressure ulcers, which can be prevented by nursing care and recognised as a quality indicator, the decision-making process of the nurse is crucial and care should be supported with evidence-based practices.

5 | CONCLUSION

In the study, we aimed to investigate the impact of two different ET fixation methods used in the ICU on the for- mation of oral pressure ulcers. We found out that the bandage method was better than the ETT method in terms of both the Pressure Ulcer Risk Score difference and the tendency to fall, dislocate or remain fixed. Based on the scores obtained from the Pressure Ulcer Scale for Healing, the patients who were subjected to the bandage

fixation method showed more improvement compared to the other groups. Deciding on the proper ET fixation method for the intubated patient and fixation of ET safely are vital in the care provided to intensive care patients. Using a safe ET fixation method helps in ensuring the comfort of patients and it is recommended to use evidence-based practices in ET fixation methods.

ACKNOWLEDGEMENTS We thank all the staff members in the ICU for the data collection and for input, observation and advice.

CONFLICT OF INTEREST The authors declare no conflict of interest.

DATA AVAILABILITY STATEMENT The data have analysed during the current study are avail- able from the corresponding author on reasonablereques.

ETHICS STATEMENT The study was approved by the Clinical Ethical Commit- tee of Marmara University Medical Faculty, No: 09.2020. 264. Clinical Trial No: NCT05142579.

ORCID Tulin Yildiz https://orcid.org/0000-0002-4981-6671

REFERENCES 1. National Pressure Ulcer Advisory Panel -NPUAP. Announces a

change in terminology from pressure ulcer to pressure injury and updates the stages of pressure injury. 2016. [Online]. http://www.npuap.org/.

2. Schmitt S, Andries MK, Ashmore PM, Brunette G, Judge K, Bonham PA. WOCN society position paper: Avoidable versus unavoidable pressure ulcers/ınjuries. J Wound Ostomy Conti- nence Nurs. 2017;44(5):458-468.

3. Marshall JC, Bosco L, Adhikari NK, et al. What _Is an intensive care unit? A report of the task force of the world federation of societies of intensive and critical care medicine. J Crit Care. 2017;37:270-276. doi:10.1016/j.jcrc.2016.07.015

4. Demir UY, Korkmaz F. Yo�gun Bakımda Hemşirenin Hissi Tar- afı “Sefkat” Ve Bakım. Yo�gun Bakım Hemşireli�gi Dergisi. 2016; 20(2):108-115.

5. Dogu T, Karakuzu Z, Delibaş KŞ, et al. Prognosis of patients in a first level intensive care unit. Int J Clin Res. 2014;2(4): 143-148.

6. Avcı O. Yo�gun bakımda basınç yarası gelişmiş hastaların de�gerlendirilmesi. Turkiye Klinikleri Journal of Nursing Sci- ences. 2014;11(3):239-244. doi:10.5336/nurses.2018-64013

7. Hampson J, Green C, Stewart J, et al. Impact of the introduc- tion of an endotracheal tube attachment device on the inci- dence and severity of oral pressure injuries in the intensive care unit. BMC Nurs. 2018;17(4):1-8. doi:10.1186/s12912-018- 0274-2

8. Kim CH, Kim MS, Kang MJ, Kim HH, Park NJ, Jung HK. Oral mucosa pressure ulcers in intensive care unit patients. J Tissue Viability. 2019;28(1):27-34. doi:10.1016/j.jtv.2018.11.002

1602 GENC AND YILDIZ

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense

9. Altun UG, Cam T. Yo�gun bakım ünitelerinde endotrakeal tüp tespitinde kullanılan yöntemler. Mersin Üniversitesi Sa�glık Bilimleri Dergisi. 2018;11(2):226-232. doi:10.26559/mersinsbd. 341866

10. Kwon E, Choi K. Case-control study on risk factors of unplanned extubation based on patient safety model in criti- cally III patients with mechanical ventilation. Asian Nurs Res. 2017;11(1):74-78. doi:10.1016/j.anr.2017.03.004

11. Keskin G, Akin M, Unal D. Fixation of endotracheal tube in a pediatric patient with facial and neck burn injury; A novel technique. Trends Anaesthes Critic Care. 2018;21:57-59. doi: 10.1016/j.tacc.2018.05.002

12. Mohammed HM, Hassan MS. Endotracheal tube securements: effectiveness of three techniques among orally intubated patients. The Egypt Soc Chest Dis Tuberculosis. 2015;64(1):183- 196. doi:10.1016/j.ejcdt.2014.09.006

13. Reaper S, Green C, Gupta S, Tiruvoipati R. Inter-rater reliabil- ity of the Reaper Oral mucosa pressure injury scale (ROMPIS): A novel scale for the assessment of the severity of pressure injuries to the mouth and oral mucosa. Aust Crit Care. 2017; 30(3):167-171. doi:10.1016/j.aucc.2016.06.003

14. Hanönü S, Karada�g A. A prospective descriptive study to deter- mine the rate and characteristics of and risk factors for the development of medical device-related pressure ulcers in inten- sive care units. Ostomy/Wound Manag. 2016;62(2):12-22.

15. Bergstrom N, Braden B, Laguzza A, Holman V. The Braden scale for predicting pressure sore risk. Nurs Res. 1987;36(4): 205-210.

16. O�guz S, Olgun N. Braden Ölçe�gi ile Hastaların Risklerinin Bel- irlenmesi ve Planlı Hemşirelik Bakımının Bası Yaralarının Önlenmesindeki Etkisinin Saptanması. Hemşirelik Forum Dergisi. 1997;2(1):131-135.

17. Ostomi Y. _Inkontinans Hemşireleri Derne�gi. Basınç Yaralanması Ve Aşamaları (Pressure Injury Stages). 2017; [Online]. https:// www.yoihd.org.tr/images/cust_files/200121090534.pdf

18. Eilers J, Berger AM, Petersen MC. Development testing.And application of the oral assessment guide. Oncol Nurs Forum. 1988;15:325-330.

19. Ozyürek P, Yavuz Van Giersbergen M. basınç yarası. In: Eti Aslan F, Olgun N, eds. Yo�gun Bakım Seçilmiş Semptom ve Bulguların Yönetimi. Ankara: Akademisyen Tıp Kitabevi; 2016: 182-215.

20. Kula ŞŞ. Pressure sore and malnutrition. J Inonu Univ Health Serv Vocat School. 2020;8(3):933-945. doi:10.33715/inonusaglik. 753479

21. Karslı BP, Gürçay E, Cankurtaran D, Karaahmet OZ, Çakçı A. Factors affecting the stages of pressure ulcers. J PMR Sci. 2016; 19(3):154-159.

22. Choi BK, Kimb MS, Kimc SH. Risk prediction models for the development of oral-mucosal pressure injuries in intubated patients in intensive care units: A prospective observational study. J Tissue Viability. 2020;29(4):252-257. doi:10.1016/j.jtv. 2020.06.002

23. Zaratkiewicz S, Teegardin C, Whitney J. Retrospective review of the reduction of oral pressure ulcers in mechanically venti- lated patients: a change in practice. Crit Care Nurs Q. 2012;35: 247-254.

24. Zeigler M, Smiley J, Jones LE, Moore JL. Use of the pressure ulcer scale for healing in inpatient rehabilitation: A case exam- ple. Rehabil Nurs. 2016;41:207-210.

How to cite this article: Genc A, Yildiz T. The impact of two distinct endotracheal tube fixation on the formation of pressure ulcer in the intensive care unit: A randomised controlled trial. Int Wound J. 2022;19(6):1594-1603. doi:10.1111/iwj.13757

GENC AND YILDIZ 1603

1742481x, 2022, 6, D ow

nloaded from https://onlinelibrary.w

iley.com /doi/10.1111/iw

j.13757, W iley O

nline L ibrary on [18/01/2024]. See the T

erm s and C

onditions (https://onlinelibrary.w iley.com

/term s-and-conditions) on W

iley O nline L

ibrary for rules of use; O A

articles are governed by the applicable C reative C

om m

ons L icense