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ORIGINAL ARTICLE
Year : 2020  |  Volume : 23  |  Issue : 1  |  Page : 91-97

Effect of transparent film on the duration of pressure ulcer formation for noninvasive ventilation patients: A randomized controlled trial


1 Department of Chest Diseases, Ege University Hospital, Izmir, Turkey
2 Ege University Faculty of Nursing, Internal Medicine Nursing, Izmir, Turkey

Date of Submission28-Dec-2018
Date of Acceptance16-Sep-2019
Date of Web Publication10-Jan-2020

Correspondence Address:
Dr. G Ozbudak
Department of Chest Diseases, Ege University Hospital, Bornova, Izmir 35100
Turkey
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/njcp.njcp_673_18

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   Abstract 


Background: Due to the prolonged use of face mask in noninvasive ventilation, pressure ulcer is a common complication. Pressure ulcer can occur within a few hours at the site where the mask contacts in 2-70% of cases. Aims: The aim of this study is to conduct a randomized controlled trial to investigate the effects of transparent film use on the duration of pressure ulcer formation in the nasal region in patients undergoing noninvasive ventilation. Methods: This study was a randomized controlled trial. 46 patients who met the sample selection criteria and agreed to participate in the study were included in the study at a university hospital in İzmir, Turkey. Of them, 25 were assigned to the intervention group and 21 to the control group. Data were collected using the Socio-demographic and Disease-related Characteristics Questionnaire, The Noninvasive Ventilation Parameters Monitoring Form, and The Pressure Ulcer Classification Form at 4-hour intervals. Results: The duration of pressure ulcer formation in intervention group was longer than that in control group, and the difference between them was statistically significant (P < 0.05). Conclusion: In this study, the use of nasal protective film (transparent film) prolonged the duration of pressure ulcer formation on the nasal bridge in patients who underwent noninvasive mechanical ventilation.

Keywords: Noninvasive ventilation, nursing, pressure ulcer, transparent film


How to cite this article:
Ozbudak G, Yesilbalkan O U. Effect of transparent film on the duration of pressure ulcer formation for noninvasive ventilation patients: A randomized controlled trial. Niger J Clin Pract 2020;23:91-7

How to cite this URL:
Ozbudak G, Yesilbalkan O U. Effect of transparent film on the duration of pressure ulcer formation for noninvasive ventilation patients: A randomized controlled trial. Niger J Clin Pract [serial online] 2020 [cited 2020 Jan 26];23:91-7. Available from: http://www.njcponline.com/text.asp?2020/23/1/91/275629




   Introduction Top


Noninvasive ventilation (NIV) is the application of ventilation with types of mask differ as opposed to using an artificial airway invasive procedures such as tracheostomy or endotracheal tube, when conditions such as hypoxemia and/or hypercapnia in patients with respiratory failure cannot be controlled by pharmacological treatment.[1] The use of NIV as the first choice in patients prevents complications such as upper airway injuries, tracheal stenosis and nosocomial pneumonia developing which are associated with intubation.[2] In addition, NIV has some other advantages such as eating, talking, taking medications orally, no need for sedation, short duration of hospitalization and low mortality rates.[3],[4]

However, air leak in the mask, discomfort caused by the mask and the development of pressure ulcers which are common problems affect the success of NIV.[2],[5] Selection of a mask matching the anatomical structure of the patient's face and holding the mask in place with adhesive tape are of great importance. If the mask is too loose, air leaks too much, and if the mask is too tight, pressure ulcers develop especially in the skin of the nasal bridge which can be avoided.[6],[7] Patients may not comply with the NIV therapy due to the discomfort or irritation caused by the mask.[6]

A pressure ulcer is defined by the National Pressure Ulcer Advisory Panel (NPUAP) as “localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear”.[8] Pressure ulcers develop due to pressure, shearing or friction. Due to the prolonged use of a mask in NIV, pressure ulcer is a common complication. Pressure ulcer can occur within a few hours at the site where the mask contacts in 2-70% of cases.[9]

In addition, patients with marked nasal humps are at higher risk of developing pressure ulcers of the nasal bridge.[9] Risk factors such as age, gender, and albumin and hemoglobin values should also be taken into account.[6],[10] Most of the patient-dependent risk factors cannot be changed, but there are some suggestions to prevent pressure ulcers from developing in the nasal bridge.[10],[11] Among these suggestions are the use of barriers under the masks, frequent evaluation and early diagnosis of hyperemia. The experience and expertise of the nurse also plays an important role.[11] In a study conducted by Verder et al. (2009), the right technique used by experienced nurses was reported to greatly contribute to the prevention of nasal pressure ulcers.[12]

To protect the skin, transparent membranes or hydrocolloid dressings can be used the moistness of the epidermis maintained by applying appropriate moisturizers.[13]

Despite extensive use of NIV and awareness of the risk of pressure ulcers caused by masks, very little data is available.[14] Studies on the prevention of pressure ulcer formation on the nasal bridge in patients using NIV are very few, and the literature screening has demonstrated that there is limited research conducted on the subject.

Callaghan and Trapp (1998) found that using Granuflex dressing with NIV (Granuflex® dressing by Convatec) as a protective material in the nasal region helps patients' skin conditions and comforts.[15]

In Wang et al.'s study (2016), foam protective film was used to prevent pressure ulcer formation on the nasal bridge in patients undergoing NIV, preventing the development of pressure ulcers.[16]

Finally, in a study conducted by Weng (2008), transparent film used to prevent pressure ulcers on the nasal bridge prevented or at least reduced the formation of pressure ulcers caused by noninvasive masks.[6]

The aforementioned data suggest that the use of transparent film placed on the nasal bridge before the noninvasive mask is placed will delay the formation of pressure ulcers, increase the comfort of the patients and hopefully improve their quality of life. The results of the present study will provide guidance for and help nurses working in this field.

The aim of the study was to investigate the effects of transparent film use on the duration of pressure ulcer formation in the nasal region in patients undergoing NIV.


   Methods Top


Design

This study was designed as a randomised controlled trial (RCT) to compare the duration of pressure ulcer formation on the nasal bridge in patients using transparent film with patients not using transparent film.

Ethical considerations

The study was approved by the ethic committee (reference number: 2014-115). All the participants were informed of the study before participating and gave their written informed consent. The study was approved by the university hospital administration.

Sample/Participants

This randomised control trial was performed at the chest diseases intensive care unit in the university hospital in Izmir, Turkey. Using the primary outcome, a power calculation showed that 40 participants (intervention and control group) were needed to detect a 20% difference in the duration time of occurrence of pressure ulcers using 85% power and a 5% significance level. However, considering potential losses from follow-up, the target sample size was 70, with15 more patients assigned to each group. 10 patients were excluded from the study because they do not meet inclusion criteria.

The inclusion criteria were (a) over the age of 18, (b) diagnosed with respiratory failure, (c) undergoing NIV for the first time, (d) receiving NIV with an oronasal mask, (e) continued ventilation, (f) no skin breakdown or pressure ulcer on face, (g) able to tolerate the NIV mask, (h) conscious and able to communicate, (i) did not have claustrophobia.

The exclusion criteria were redness or pressure ulcers were in stage I or higher, a history of glaucoma or eye surgery within the past 6 weeks, use at home noninvasive ventilation in the hospital, and women who were pregnant. The participants were assigned either to the control group or to the intervention group. The flowchart presented in [Figure 1] shows the number of the patients eligible for the study, the exclusions and reasons for exclusions, and the number of the patients lost to follow up. 46 patients (25 in the intervention group, 21 in the control group) were recruited to the study.
Figure 1: Research flowchart

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Intervention

To obtain standard and reliable data, application of NIV and transparent film was performed by the researcher in accordance with the procedure steps given in [Table 1].[15]
Table 1: Steps of noninvasive mechanical ventilation

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Transparent film was applied to the participants in the intervention group, before the oronasal mask was placed. Transparent film is permeable to water vapor and it is easy to observe the skin condition through a transparent material. Transparent film was used to cover the nasal bridge, and the mask was then applied by the researcher, and noninvasive ventilation initiated by the doctor.

Data collection

46 patients were recruited between January 2015 and October 2015. The data were first collected from the control group then from the intervention group to avoid interaction in intervention and control group. Patients were observed every 4 hours by the same researcher to see whether pressure ulcer developed. The intervention was discontinued in patients who developed Stage 1 pressure ulcer.

The following data were collected from participants.

Pre-intervention

(1)The Socio demographic and Disease-related Characteristics Questionnaire including items questioning gender, age, height, weight, occupation, education status, income status, diagnosis, dependency level, medication used, intensive care stay, chronic diseases, use of cigarettes, use of corticosteroids, albumin value (g/dl), hemoglobin value (g/dl) and plasma glucose value (g/dl).

Post-intervention

  1. Mask size used.[6],[15]
  2. The Noninvasive Ventilation Parameters Monitoring Form questioning the patients' IPAP and EPAP pressure values, the amount of air leak (l/min) and duration of NIV application (hours/day).[17]
  3. “International The National Pressure Ulcer Advisory Panel (NPUAP), European Pressure Ulcer Advisory Panel (EPUAP) Pressure Ulcer Classification Form”[8] administered at 4-hour intervals.


Data analysis

After the data collected were coded and accuracy of the data was checked, the SPSS version 16.0 software was used to perform the statistical analysis. Continuous variables were expressed as mean ± standard deviation, and categorical variables as frequency and percentage, and in order to assess the compliance with normal distribution, Shapiro Wilk Test (95%); to compare categorical variables between groups, the Chi-square test, t-test in paired (paired sample t-test), independent (independent sample t-test) and Mann Whitney U test were employed. A P value of less than 0.05 was considered statistically significant for all the tests.


   Results Top


The data on the socio-demographic and disease-related characteristics of the participants are shown in [Table 2]. Socio-demographic and disease-related characteristics of the participants; While most of the patients in the intervention group (52%) were female, in the control group most of them (57.1%) were male. The mean age of the patients in the intervention and control groups was 69.3 ± 1.73 years. The patients had similar characteristics in terms of their mean age, profession and educational status. There was no statistically significant difference between the two groups in terms of their socio-demographic characteristics (P > 0.05) and the groups were homogeneous.
Table 2: Socio-demographic and disease-related characteristics of the patients

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Of the participating patients, 60% in the intervention group and 76.2% in the control group were smokers, 76% in the intervention group and 66.7% in the control group were above the normal weight limit, 72% in the intervention group and 76.2% in the control group had not taken corticosteroids within the last 3 months, and 56.0% in the intervention group and 57.1% in the control group did not use corticosteroids during the NIV treatment [Table 3].
Table 3: Some risk factors for developing pressure ulcer

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There was no statistically significant difference between the two groups in terms of pressure ulcer risk factors (P > 0.05).

The mean albumin, hemoglobin and plasma glucose levels of the patients in the intervention group were 3.2 ± 0.63 (g/dl), 11.1 ± 2.07 (g/dl) and 140.6 ± 44.3 (g/dl) respectively. The mean albumin, hemoglobin and plasma glucose levels of the patients in the control group were 3.2 ± 0.61 g/dl, 11.8 ± 2.17 g/dl and 155.5 ± 42.3 g/dl, respectively. While the mean duration of stage I pressure ulcer development was 20.96 ± 5.07 hours in the patients in the intervention group, it was 7.61 ± 3.07 hours in the patients in the control group. The difference was statistically significant (Z: - 5.719/P: 0.001) [Table 4].
Table 4: Comparisons of the mean duration of pressure ulcer development in patients in the intervention and control groups

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There was a moderate negative correlation between the duration of pressure ulcer formation and the age of the patients in the intervention group (r: -0.521, P: 0.008), and a weak positive correlation between the duration of pressure ulcer formation and the albumin level (r: 0.460, P: 0.021). And no correlation was determined between the duration of pressure ulcer formation and the patients' BMI, hemoglobin and plasma glucose values (P > 0.05).

There was no significant relationship between the duration of pressure ulcer formation and the control group patients' age, BMI, hemoglobin value, plasma glucose levels (P > 0.05).

However, there was a weak positive correlation between the albumin levels of the patients and the duration of pressure ulcer formation (P < 0.05). The duration of pressure ulcer formation was longer in the patients having used corticosteroids within the last 3 months and during the NIV treatment, and having transparent film during the NIV treatment than that in the patients in the control group (P: 0.004).


   Discussion Top


Skin complication of nasal mask usage is common and may lead to the disruption of the treatment in a significant proportion of patients undergoing long term NIV. In a study, 17% of the patients developed pressure ulcer at the nasal bridge and a small number developed chronic ulceration at this site.[18] Among the best ways to avoid irritation are the selection of correct mask size and type, and proper adjustment of head straps. Protective materials also protect the patient from irritation caused by the mask.[19]

In this present study, the use of nasal protective film (transparent film) prolonged the duration of pressure ulcer formation on the nasal bridge in patients who underwent noninvasive ventilation.

Similar to the results of the present study, in the study conducted by Weng (2008), the duration of the pressure ulcer formation was significantly longer in the group using transparent film than that in the control group,[6] in the study conducted by Callaghan (1998), the use of Granuflex dressing delayed pressure ulcer formation on the nasal bridge[15] and in another study, the incidence of nasal pressure ulcer formation was found to be lower in the group which the use of a solution hyperoxygenated fatty acids and adhesive thin dressing compared with other strategies.[20] In a study by Wang et al. (2016), foam film used on the nasal bridge in patients undergoing NIV also prevented pressure ulcer formation.[16] Protective film pressure does not completely prevent ulcer formation, but it can reduce friction, shearing and effects of pressure.[21] In the literature, protective materials such as transparent film, silicone, thin sponge or hydrocolloid are indicated to be useful in preventing pressure ulcers.[13],[22]

In advanced age, pressure ulcers develop in shorter time because the aged skin is thin, delicate and has lost its elasticity. Fibroblast production rate decreases and thus causes a decrease in collagen production. Due to low elastin production, the skin loses its elasticity and its resistance to shearing and friction is reduced.[23]

In Weng's study (2008), 87% of the patients undergoing NIV were older than 65 years and most of the patients developed pressure ulcers.[6] In other studies except nasal bridge pressure studies conducted by Tayyib et al. (2013), Tsaousi et al. (2015) and Gardiner et al. (2014), a significant relationship was determined between pressure ulcer formation and advanced age.[23],[24],[25]

Hypoalbuminemia leads to oncotic pressure changes, and thus to oedema which alone is a major factor causing the development of pressure ulcers. Subsequent to the development of oedema, tissue integrity is easily impaired by a small pressure, friction or irritation.[26]

In studies by Ahn et al., (2016) and Tokgöz and Demir (2010) low albumin value was determined as a risk factor associated with the development of pressure ulcers.[27],[28]

Many factors lead to skin necrosis on the nasal bridge. The leading causes are hypotension, reduction in skin turgor due to hypovolemia and the thinning of the skin due to the long-term use of corticosteroids.[29]

In a study by Ahmad et al. (2013), in patients receiving the NIV, having corticosteroid therapy during the NIV was a risk factor for pressure ulcers.[30] In a study by Jones et al. (1994), 5 of the 14 patients taking oral steroids during the NIV developed major problems such as skin rupture and wound formation compared to the patients not taking oral steroids. In a study by Jones et al. (1994), patients taking oral steroids were at a particular risk of developing persistent ulceration.[18]

The results obtained in the present study were different from those of the aforementioned literature. In other words, the duration of pressure ulcer formation was longer in the patients who took corticosteroids and had transparent film during the NIV than in the patients who did not, and skin problems related to steroid use in the former patients were delayed.

In our intensive care unit, however, individual attention to problems led to resolution of complications and rapid healing of ulceration in all the cases with consequent restoration of the effective therapy.

We believe that early identification of those patients at greatest risk of developing nasal mask complications, and appropriate intervention will lead to an improvement in patient compliance and greater long-term efficacy of domiciliary ventilatory support.

Limitations

There were some limitations of our study. The first of these is the use of a single protective material in the study. Turkey's west have been made in a single intensive care is another limitation. For this reason, the results of all NIV-treated patients cannot be generalized.


   Conclusion and Recommendations Top


In conclusion, using transparent film in patients during the NIV can impede the formation of pressure ulcers on the nasal region (P < 0.05). Routine evaluation of skin and use of skin barrier strategies to reduce skin damage should be included in the routine application of NIV.

It is recommended to use training programs to increase nurses' awareness of pressure ulcer development on the nasal region, to conduct randomized controlled studies with larger sample sizes, to conduct studies that determine the effect of different types of protective materials on the duration of pressure ulcer formation in the nasal region, and to use the findings of the present study as a data source for future investigations.

Acknowledgments

We wish to thank all the patients who so willingly participated in this study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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  [Table 1], [Table 2], [Table 3], [Table 4]



 

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