Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513936
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Nursing Interventions on Prevention Medical Device Related Pressure Injury MDRPI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Implementing Nursing Interventions on Prevention Medical Device Related Pressure Injury in Critically Ill Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MDRPI
Brief Summary:
This study aims to assess the effect of implementing nursing interventions on preventing medical device related pressure injury in critically ill patients
Research hypothesis
Critically ill patients who experienced nursing interventions have a significantly lower risk of developing medical device related pressure injury than those who do not
Research hypothesis
Critically ill patients who experienced nursing interventions have a significantly lower risk of developing medical device related pressure injury than those who do not
Detailed Description:
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 patients 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 studys 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 patients 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
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 patients 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 studys 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None