Incidence and risk factors for medical device‐related pressure ulcers: The first report in this regard in Iran

Abstract

Few studies, especially among developing countries such as Iran, have been conducted on the incidence and risk factors for medical device‐related pressure ulcers (MDRPUs). Given the importance of this issue and the lack of previous studies, the present study aimed to investigate the incidence and risk factors for MDRPUs in Iran. The present descriptive‐analytical study was conducted at three hospitals in Qazvin, Iran, from June 1, 2019, to September 1, 2019. Data collection took approximately 3 months from July to September 2019. Sampling was carried out through a convenience sampling method, and the samples consisted of 404 patients. For data collection, a checklist for demographic variables, a checklist for patient‐connected medical devices, Braden Scale, Glasgow Coma Scale, National Pressure Ulcer Advisory Panel Pressure Grading Scale, and Nutrition Risk Screening 2002 were used. Of the 404 patients studied, 20.54% (n = 83) developed some degree of MDRPUs. From those, 61 (70.11%) were in stage I, 17 (19.5%) were in stage II, and 9 (10.34%) were in stage III. Among the nine medical devices that caused pressure ulcers, the most commonly reported ones were nasal oxygen tubes (31 cases), oxygen face masks (23 cases), and endotracheal tubes (17 cases). The mean score of Braden Scale (P = .004), the mean score of NRS 2002 (P = .037), older age (P = .007), male gender (P = .002), the average length of stay in hospitals (P = .001), and having pressure ulcers in body (P = .025) significantly increased the possibility of occurring MDRPUs. In the present study, the incidence of MDRPUs was high. Taking the necessary measures into consideration in order to prevent the MDRPUs is essential in Iranian hospitals. Further studies in this regard are strongly recommended.

1. INTRODUCTION

In recent years, the National Pressure Ulcer Advisory Panel (NPUAP) has revised the definition of pressure ulcer and included the medical device‐related pressure ulcers (MDRPUs) in it.1 According to the definition of this panel, MDRPUs occurred as the result of the use of devices designed and applied for diagnostic or therapeutic purposes. The resulting pressure ulcer generally conforms to the pattern or shape of the device.1 The possibility of occurring MDRPU has increased due to the development of technology and the increased use of medical devices for patients.2 According to the results of one study, the risk of pressure ulcer development in patients with medical devices is 2.4 times greater than that in other patients.3 In addition to affecting patients' well‐being, such injuries can incur significant costs for healthcare systems.4 These injuries can also result in pain, increased infection rates, and delayed hospital discharge.2 It is worth mentioning that in assessing the quality of nursing care and the patients' safety, MDRPU can be considered as one of the main indicators as well.5

MDRPUs have gained more attention over the past decade. Prior to 2010, a very few studies on the incidence and prevalence of such ulcers are available in the literature. Since 2010, the number of studies related to this issue has increased remarkably. Although this increase has been significant over the past 3 years, the number of studies in this regard is still limited. Jackson et al, in their review study that screened published articles by the end of December 2018, found only 29 studies on the incidence and prevalence of MDRPUs.5 The prevalence or incidence and risk factors associated with MDRPU in previous studies have been highly variable with respect to the methods used in the studies as well as the study settings. Studies in India, South Korea, Australia, and the United States reported incidence or prevalence of MDRPUs of 19.2%, 19.8%, 27.9%, and 47%, respectively.6, 7, 8, 9

Preventing MDRPUs is much more difficult than the usual pressure ulcers because the use of these devices is unavoidable in some patients; and in some cases, it is not possible for healthcare team members to examine the area under the medical devices.10 Having adequate information about the incidence and risk factors for MDRPU is necessary to take preventive measures in this regard. As noted earlier, studies related to the MDRPUs are limited throughout the world, and this limitation is much more considerable in developing countries such as Iran. Our searches in Iran regarding MDRPU are limited to a few case reports, and there is virtually no comprehensive information on MDRPU in Iran.11, 12, 13, 14 Therefore, due to the lack of international studies and lack of studies in Iran, the present study was conducted to investigate the incidence and risk factors for MDRPU.

2. METHODS

The present descriptive‐analytical study was conducted at three hospitals in Qazvin, Iran, from 1 June 2019 to 1 September 2019. In these hospitals, no specific protocol was used to prevent or treat MDRPUs. The study samples consisted of all the patients who were connected to at least one medical device for at least 1 hour at the time of the study. Patients, who were unwilling to participate in the study, were excluded. Sampling was performed through a convenience sampling method. Incidence in our study defined as a number of patients who developed one or more MDRPUs in relation to all patients who were assessed.

According to one study in India in 2018 by Mehta et al,6 which investigated the prevalence and risk factors for MDRPUs in the intensive care unit, the prevalence of MDRPU was reported as 19.2% (P = .192) (q = 0.808). Therefore, considering the type I error of α = 0.05 (95% confidence level) and the P error of d = 0.2, the sample size was determined to be 404 using the following formula.

$$n=\frac{z_{1-\frac{\alpha }{2}}^2*p\left(1-p\right)}{d^2}=\frac{1.96^2*0.192*0.808}{0.0384^2}=404.$$

For data collection, two of the researchers (LSh and MN) referred to the hospitals and received a list of patients who have medical devices from the wards' head nurses. The referral to each hospital was once every 3 days (two times in 1 week). At each referral to three hospitals, about 30 to 40 patients were enrolled to the study. All the referrals to hospital wards were made in the morning shifts from 8:00 am to 1:00 pm by two of researchers (LSh and MN). Then, the skin under the medical device area was assessed for any signs of MDRPUs by LSh and MN with the help of the hospital nurses who were responsible for the patients care. After this, all checklists were completed by LSh and MN for each of the patients. Both investigators (LSh and MN) were trained about MDRPUs. When they found any MDRPU, it was informed to other researchers HR and FR who are both faculty members and specialists in wound care, especially pressure ulcer.

For each patient, a checklist for demographic variables was completed. This checklist included items about patients' age, sex, ward, cause of hospitalisation, and the length of stay in hospital. In addition to this, a checklist for patient‐connected medical devices was completed for each patient. This checklist included the names of 24 medical devices that caused pressure ulcers in previous studies. The Braden Scale was also completed for each patient. This scale contains five subscales that identify people at moderate‐to‐high risk of pressure ulcer development. A lower score on this scale indicates a higher risk of pressure ulcer development. In order to determine the grade of pressure ulcers, NPUAP Pressure Grading Scale was used. According to this scale, pressure ulcers are classified into 6 stages. Glasgow Coma Scale was used to assess patients' level of consciousness. Scoring in this scale is from 3 to 15, and a lower score indicates a lower level of consciousness. Also, in order to assess the nutritional status of patients, Nutrition Risk Screening 2002 (NRS 2002) was used. This tool consists of two main parts: impaired nutritional risk and severity of disease. A score higher than 3 in this tool indicates a poorer nutritional status.

3. ETHICAL CONSIDERATIONS

The proposal of the present study was reviewed and approved by the Research Council of Qazvin School of Nursing and Midwifery and obtained the code of ethics (code of ethics: IR.QUMS.REC.1398.034). Prior to conducting the study, the coordination was made with the managers of all three hospitals. Prior to enrolling the samples to the study, the aims and methods of study were explained to them (if they were conscious) or their guardians (if they were unconscious). The informed consent form was signed by the patient or his/her guardian. Collected data were used only for the purposes set out in the approved proposal. In addition to this, the confidentiality regarding the patients' personal information was also considered by the researchers through all stages of the study.

4. DATA ANALYSIS

Collected data were entered into SPSS v16. According to the normal distribution of data based on the results of K/S test, parametric tests were used to analyse the data. In this study, independent t‐test and chi‐square test were used. P value of less than .05 was considered significant in both tests.

5. RESULTS

The mean age of participants was 65.8 ± 17.1 years (ranging 8 to 94). Of the 404 patients studied, 56.4% (n = 228) were men and others were women.

Of the 404 patients studied, 20.54% (n = 83) developed some degree of MDRPUs. Two patients had more than one MDRPUs. In terms of severity, 61 (70.11%) were in stage I, 17 (19.5%) were in stage II, and 9 (10.34%) were in stage III. In terms of anatomic locations, most MDRPUs occurred on the head (50%). In terms of medical devices, 9 devices were found to cause ulcers. Among the 9 medical devices caused MDRPUs, the most commonly reported ones were nasal oxygen tubes (31 cases), oxygen face masks (23 cases), and endotracheal tubes (17 cases). However, when we considered percentage of MDRPU caused by each device, bilevel positive airway pressure (BIPAP) mask 3 (60%), cervical collar 3 (42.85%), and oxygen face mask 23 (34.84%) were most common medical devices. Most grade 3 MDRPUs were caused by oxygen face mask (23 cases) and nasogastric tube (NG) tube and endotracheal tube (17 cases). Table 1 shows the devices that caused MDRPUs and the frequency of ulcers by each device (Table 1). Also, Table 2 shows the incidence and the stages of MDRPUs for each ward (Table 2).

Table 1.

Devices that caused pressure ulcers and the frequency of ulcers by each device

Devices	Used number	Number and percent of MDRPU	Stage 1	Stage 2	Stage 3
Oxygen face mask	66	23 (34.84%)	13 (56.5%)	7 (30.4%)	3 (13%)
Nasal oxygen tubes	181	31 (17.12%)	25 (80.64%)	5 (16.12%)	1 (3.22%)
Endotracheal tube	86	17 (19.76%)	12 (70.58%)	3 (17.64%)	2 (11.76%)
Tracheostomy	36	2 (5.5%)	2 (100%)	‐	‐
NG tube	200	5 (2.5%)	2 (40%)	2 (40%)	1 (20%)
BIPAP mask	5	3 (60%)	3 (100)	‐	‐
Pulse oximeter	126	2 (1.58%)	1 (50%)	‐	1 (50%)
Cervical collar	7	3 (42.85%)	2 (66.66%)	‐	1 (33.33%)
Split	3	1 (33.33%)	1 (100%)	‐	‐
Total	710	87 (20.3%)a	61 (70.11%)	17 (19.5%)	9 (10.34%)

^aTwo patients have more than one MDRPUs in more than one site.

Table 2.

Incidence and the stages of MDRPUs for each ward

Ward	Patients number	Number and percent of MDRPU	Stage 1	Stage 2	Stage 3
ICU	191	39 (19.9%)	28	11	3
Medical and surgical	90	22 (24.4%)	12	2	4
Infection	38	9 (23.68%)	4	3	1
Neurology	28	6 (21.4%)	5	1	‐
Emergency	57	11 (19.10%)	1	‐	1
Total	404	83 (20.54%)a	61	17	9

Abbreviations: BIPAP, bilevel positive airway pressure; NG, nasogastric tube.

^aTwo patients have more than one MDRPUs in more than one site.

The mean score of the Braden Scale in patients with MDRPU was 13.5, and in patients without MDRPU, it was 14.9. The difference between the two groups was statistically significant (P = .004). Regarding the subscales of the Braden Scale, the mean score in patients with MDRPU was lower in all subscales compared with patients without pressure ulcers (Table 3). The mean scores of Glasgow Coma Scale in patients with and without MDRPUs were 11.6 and 12.3, respectively. According to the results of independent t‐test, the difference between the two groups was not statistically significant (P < .116). The mean scores of NRS 2002 in patients with and without MDRPUs were 4.3 and 3.3, respectively. According to the results of independent t‐test, the difference between the two groups was statistically significant (P = .037). Among the demographic variables, older age, male gender, the average length of stay in hospitals, and having pressure ulcers in body significantly increased the possibility of occurring MDRPUs. The details are presented in Table 4.

Table 3.

Mean score of Braden scale in patients with and without MDRPU

Item	With MDRPU	Without MDRPU	P value
Sensory perception	2.7 ± 0.9	3.1 ± 1.1	.008
Moisture	3.1 ± 0.7	3.3 ± 0.6	.174
Activity	1.2 ± 06	1.6 ± 1.2	.009
Mobility	2.2 ± 0.9	2.6 ± 1.1	.003
Nutrition	2.2 ± 0.8	2.5 ± 1.1	.041
Friction and shear	1.8 ± 0.82	2 ± 0.84	.049
Total Braden score	13.5 ± 3.6	14.9 ± 3.6	.004

Table 4.

Patients' demographic characteristics and their relationship with MDRPU development

Item		With MDRPU	Without MDRPU	P value
Age		69.9 ± 16.3	64.3 ± 17.3	.007
Hospital stay		10.6 ± 12.8	5.8 ± 7.2	.001
Blood albumin level		3.1 ± 0.5	3.3 ± 1.4	.149
Blood haemoglobin level		11.6 ± 2.3	11.8 ± 2.8	.385
Sex	Male	59	169	.002
	Female	23	153
Ward	ICU	38	153	.978
	Medical and surgical	20	70
	Emergency	10	46
	Infection	8	30
	Neurology	6	23
Ventilation type	Mechanical	24	76	.179
	Spontaneous	58	246
Having usual PU	Yes	28	73	.025
	No	54	249
Hypertension	Yes	28	106	.465
	No	54	216
Diabetes mellitus	Yes	17	65	.880
	No	67	254

6. DISCUSSION

The present study is the first study in Iran that investigated the incidence and risk factors for MDRPUs. The results of this study showed that the incidence of MDRPU was 20.54%, which is relatively high. Factors including low score of Braden Scale, high score of NRS 2002, older age, male gender, the average length of stay in hospitals, and having pressure ulcers in body significantly increased the possibility of occurring MDRPU.

In recent years, many efforts have been made in Iran to improve the current status regarding the prevention and care for patients at risk of developing or currently having a pressure ulcer.15 However, little attention has been paid to the MDRPU so far. Surprisingly, in many hospitals in Iran, MDRPUs are not included in the overall statistics of pressure ulcers. The high incidence rate obtained in the present study also partly confirms this claim. In a systematic review and meta‐analysis in 2019, Jackson et al reported the incidence of MDRPU to be 12%. The incidence rate obtained in the present study is approximately twice that reported by Jackson et al, indicating the poor status with regard to MDRPU in Iran.5 It seems that urgent measures need to be taken to improve the current status in Iran. Measures such as adding content related to MDRPU to the undergraduate and postgraduate nursing curricula, improving the attitudes and knowledge of the healthcare team members regarding MDRPU, modifying the Ministry of Health's general policies on pressure ulcers, and giving more attention to MDRPU as well as applying protocols for preventing MDRPU can be mentioned.

The most commonly reported medical devices that caused pressure ulcers in the present study were nasal oxygen tubes, oxygen face masks, and endotracheal tubes. Although when we considered percentage of MDRPU caused by each device, BIPAP mask 3 (60%), cervical collar 3 (42.85%), and oxygen face mask 23 (34.84%) were most common medical devices. Most of the MDRPUs occurred on the head. In this regard, Kayser et al in their study identified nasal oxygen tubes and masks as the most commonly reported medical devices that caused pressure ulcers.16 However, in terms of severity, the damage caused in the study of Kayser et al was more severe than the present study. In the study of Mehta et al in India, the most commonly reported medical devices that caused pressure ulcers were non‐invasive ventilation mask, NG tube, and endotracheal tube, which are different from the findings of the present study.6 This difference may be due to the differences in the settings of the two studies. In Mehta et al study, only patients hospitalised at the intensive care units were assessed. Since patients hospitalised at this ward usually have mechanical ventilation, the nasal mask and cannula, which were the most commonly reported medical devices that caused pressure ulcers in the present study, are no longer used. It seems that depending on the ward at which the patient is hospitalised, the medical devices used may also be different to the fact that it should be the focus of caregivers as preventive measures may vary according to the type of devices used. In addition to nurses, it is also necessary for other medical groups including emergency medical technicians, emergency medicine specialists, ICU physicians, orthopaedic physicians, respiratory physicians, and physiotherapists to act well and are evidence based in order to prevent MDRPU.

The present study also showed that the incidence of MDRPU was higher in men and the elderly. The results of the Coyer et al study also revealed that men and individuals aged over 60 years were at a greater risk of MDRPU.17 The fragility of the skin in the elderly can be the reason for this increased risk of pressure ulcer development. Regarding gender, the notable point in the present study is that in Iran, women wear headscarves as an Islamic veil. The headscarves protect the patients' heads and ears. The women in the present study had worn the oxygen masks and nasal oxygen tubes over their headscarves, which it caused the oxygen mask straps and nasal oxygen tubes not to be directly in contact with the skin of the patients' back. In fact, the headscarves acted as a preventive dressing and prevented MDRPU development in the patients' ears.

The results of the present study also showed that the mean scores of Braden Scale and NRS 2002 in patients with MDRPU were lower and higher than patients without MDRPUs, respectively. In this regard, Black et al also reported in their study that the mean score of Braden Scale was lower in patients with MDRPU compared with patients who did not develop MDRPUs.3 Our searches did not reveal a study that examined the relationship between patient nutritional status and the development of MDRPUs. However, the results of one study in 2017 showed that the mean score of NRS 2002 was significantly associated with the development of pressure ulcers, so that patients with a higher mean score of NRS 2002 were more likely to develop pressure ulcers.18 Due to the lack of studies in this regard, further studies are recommended.

The results of the present study also showed that an increase in length of stay in hospitals was associated with the incidence of MDRPU. In this regard, we did not find a study showing the association between length of stay in hospital and MDRPU development. However, studies have shown that an increase in length of stay in hospitals increases the risk of pressure ulcer development. For instance, the study conducted by Koivunen et al in Finland in 2018 can be mentioned.19 Patients, who spend more time in the hospital, do not usually have stable condition and this issue can be effective in MDRPU development. However, further studies are needed.

7. CONCLUSIONS

The incidence of MDRPU in hospitalised patients should be considered as a negative point for the performance of healthcare team members. The results of the present study showed that the incidence of MDRPU is high in Iran. Several underlying factors also influenced the incidence of MDRPU. Health care team members should be aware that some risk factors are not modifiable such as age and sex. The prevention and treatment of MDRPU should be considered more by health care team members, especially nurses. Applying protocols for preventing MDRPU in Iranian hospitals seems to be necessary. The results of this study can be helpful in this regard. Future studies are also recommended to examine the knowledge, attitude, and performance of health care team members regarding MDRPU.

8. LIMITATIONS

The examination of the skin beneath the collar area in some patients with head and neck trauma was not possible due to complete immobility. Also, the examination of the skin beneath some splints in orthopaedic patients was not possible due to the patient's motor restriction.

CONFLICT OF INTEREST

The authors declare no conflicts of interest.

Rashvand F, Shamekhi L, Rafiei H, Nosrataghaei M. Incidence and risk factors for medical device‐related pressure ulcers: The first report in this regard in Iran. Int Wound J. 2020;17:436–442. 10.1111/iwj.13290