The Effect of Implementing Nursing Interventions on Prevention Medical Device Related Pressure Injury in Critically Ill Patients
Phase: NA
Conditions: Medical Device Site Erosion
Sponsor: Damanhour University

 
The Official Title of the study 
The effect of implementing nursing interventions on 
prevention medical device related pressure injury in critically 
ill patients. 
 
 

NCT number (if available) : Not applicable 
Date of the document: June 1, 2024 
 
 

This study aims to assess the effect of implementing nursing interventions 
on preventing medical device-related pressure injuries in critically ill 
patients. 
Operational definition: The selected nursing interventions refer to the skin 
care Bundle, which includes eight key components. 
Design and methods: 
Research design: A parallel randomized control trial research design will be 
conducted. 
Setting: The current study was conducted in intensive care units (ICUs) at 
Main Alexandria University Hospital in Egypt. Those units received patients 
with critical illness and immobility who were independent on nursing care 
to meet their basic needs. 
Subjects: 
This study will include a convenience sample of 120 critically ill patients 
who require ventilatory support. Adult patients (age ≥18 years) in the ICU 
who were more than 24 hours after admission were eligible for inclusion. 
The exclusion criteria for the patients were as follows: (i) patients who had 
skin diseases such as systemic lupus erythematosus and burns that may have 
influenced the judgment of medical device related pressure injury; (ii) 
patients who were not in the ICU for treatment or examination during the 
investigation; and (iii) patients with medical device related pressure injury 
before they were admitted to the ICU 
Tools of the study: 
Three parts make up Tool one, which evaluates general patient data. 

Part one: Patients’ characteristics such as age, sex, admission cause, history, 
length of stay, APACHE II score, body mass index, no of invasive devices 
used and mechanical ventilator duration. 
Part two: Patient clinical assessment includes vital signs such as oxygen 
saturation, albumin, type of nutritional support, level of consciousness, 
capillary refill, and edema grade. 
Part three: skin assessment. The Braden Scale for Predicting Pressure Sore 
Risk is defined as a pressure ulcer development risk prediction score that is 
based on a patient’s sensory perception, skin moisture levels, activity, 
mobility, nutrition, friction, and shearing. Scores range from 6 to 23. A score 
of 15–18 indicates that the patient is at mild risk for developing a pressure 
ulcer; a score of 13–14 indicates moderate risk; a score of 10–12 indicates 
high risk; and a score of equal to or less than 9 indicates severe risk.  
Two medical devices are used and consist of three parts. 
Part one: ICU medical device assessment: this part is used to assess the 
number of non-invasive and invasive devices and whether they are needed 
or not. Each site will be assessed for the Pressure Ulcer Staging Form based 
on classification of Pressure Ulcer Grading: 
Grade 1: non-blanchable erythema of intact skin. Discoloration of the skin, 
warmth, oedema, induration, or hardness may also be used as indicators, 
particularly in individuals with darker skin. 
Grade 2: Partial thickness skin loss involving the epidermis, dermis, or both. 
The superficial ulcer presents clinically as an abrasion or blister. 
Grade 3: Full-thickness skin loss involving damage to or necrosis of 
subcutaneous tissue that may extend down to, but not through, underlying 
fascia. 

Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, 
or supporting structures with or without full thickness skin loss 
Two medical devices are used and consist of three parts. 
Method: 
Ethical approval will be obtained from the university committee. 
After an explanation of the study’s purpose, hospitals administrative 
authorities’ permission to perform the study was acquired from selected 
hospitals. 
The reliability of the tool was established, and it was accepted. A pilot study 
was done on 10% of the studied population to assess the accessibility of two 
tools, and necessary modifications were made. 
Data collection phase: 
A letter was submitted from the Dean of the Faculty of Nursing, Damanhour 
University, to the director of intensive care units at the Alexandria main 
university in Alexandria government hospitals in Egypt. 
The validity of the instruments was verified by presenting them to five 
experts in the field of the study, who revised them. The recommended 
modifications will be made. 
On the first admission day, the researchers assessed all newly admitted 
mechanically ventilated patients to identify the exclusion criteria. They were 
assigned equally to controlled and intervention groups. 
The patients will be assigned to two equal groups: the control (A) and 
intervention (B) groups. 
Group A received routine nursing care for medical devices. 

The intervention group (B) received skin care bundle. It includes eight key 
components: 
Secure devices and protect the skin with dressings in high-risk areas. 
K: Keep repositioning more frequently than twice daily (if not medically 
contraindicated); remove the medical device as soon as medically feasible. 
Inspect the skin under the device more than twice daily; high-risk patients 
will require more frequent assessments. 
Nutrition and hydration, nutrition deprivation, and insufficient dietary intake 
are risk factors for medical device-related pressure injuries and impaired 
wound healing. 
Choose the correct size and type of medical device to fit the individual. 
A. Avoid placing devices over sites of prior or existing pressure injury or 
assess the patient’s risk status. 
Report medical device-related pressure injuries correctly and immediately; 
monitor incidence and prevalence. 
Educate staff on the correct use of devices and prevention of skin breakdown 
(younger and older patients are at high risk); never apply additional pressure 
when securing a device; and do not position the patient directly on a medical 
device unless it cannot be avoided.