Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04550182
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2020-01-06
Brief Title:
Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMESREA
Brief Summary:
Pressure ulcers represent a major health issue because of their high incidence and their important consequences There is an important risk of pressure ulcer acquisition for ICU patients with acute organ failures
Specific risk factors identified in ICU are immobility which accentuates the effects of friction and shears as well as mechanical ventilation and the use of vasopressors
A repositioning schedule is a guideline for pressure ulcer prevention but repositioning frequency remains unknown
Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale should decrease the emergence of pressure ulcer This could limit their important consequences for ICU patients which add to their brittle clinical condition infection increased length of stay mortality
Specific risk factors identified in ICU are immobility which accentuates the effects of friction and shears as well as mechanical ventilation and the use of vasopressors
A repositioning schedule is a guideline for pressure ulcer prevention but repositioning frequency remains unknown
Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale should decrease the emergence of pressure ulcer This could limit their important consequences for ICU patients which add to their brittle clinical condition infection increased length of stay mortality
Detailed Description:
This is a multicenter randomized controlled cluster parallel open study In order to avoid a contamination bias between groups this trial will be randomized at the center level This randomization will lead to the formation of 2 groups a group of control centers usual care and a group of interventional centers repositioning schedule
A visit to set up the study will be carried out before the beginning of the inclusions During this visit a training course will be delivered to the caregivers of all the research centers on the risk assessment of pressure ulcers using the Braden scale the evaluation of the skin condition the identification of the stages of pressure and their management as well as the collection of data necessary for this study In addition the interventional group centers will receive training on the application of the repositioning schedule
The risk assessment for pressure ulcers using the Braden scale will be performed daily in both groups All patients participating in research with a Braden scale 17 will benefit from a pressure ulcer prevention mattress
Usual care
Within the control group repositioning schedule frequencies and positioning will be done according to the habits of the service The daily collection form present in the room will collect information concerning the care related to the positioning of the patient length of treatment frequency of positioning type of positioning any adverse events occurring during this care the evaluation of the patients cutaneous status duration of pressure ulcer care and evaluation of the Braden scale The possible contraindications to the positioning of the patients will be informed by the doctors on the medical prescription according to the current practice
Repositioning schedule
Within the interventional group the repositioning schedule will be applied according to the risk of pressure ulcer evaluated daily by the Braden scale A medical prescription as part of the care will attest to the absence of absolute contraindication or relative to the procedure of mobilization
Depending on the result of the Braden scale the repositioning schedule is defined as follows
6 Braden 8 alternate positioning every 2 hours 9 Braden 13 alternate positioning every 4 hours 14 Braden 17 No alternative of the positioning required but a friction and an evaluation of the cutaneous state every 6 hours
18 Braden 23 No alternative of the positioning required but a friction and an evaluation of the cutaneous state every 12 hours
A visit to set up the study will be carried out before the beginning of the inclusions During this visit a training course will be delivered to the caregivers of all the research centers on the risk assessment of pressure ulcers using the Braden scale the evaluation of the skin condition the identification of the stages of pressure and their management as well as the collection of data necessary for this study In addition the interventional group centers will receive training on the application of the repositioning schedule
The risk assessment for pressure ulcers using the Braden scale will be performed daily in both groups All patients participating in research with a Braden scale 17 will benefit from a pressure ulcer prevention mattress
Usual care
Within the control group repositioning schedule frequencies and positioning will be done according to the habits of the service The daily collection form present in the room will collect information concerning the care related to the positioning of the patient length of treatment frequency of positioning type of positioning any adverse events occurring during this care the evaluation of the patients cutaneous status duration of pressure ulcer care and evaluation of the Braden scale The possible contraindications to the positioning of the patients will be informed by the doctors on the medical prescription according to the current practice
Repositioning schedule
Within the interventional group the repositioning schedule will be applied according to the risk of pressure ulcer evaluated daily by the Braden scale A medical prescription as part of the care will attest to the absence of absolute contraindication or relative to the procedure of mobilization
Depending on the result of the Braden scale the repositioning schedule is defined as follows
6 Braden 8 alternate positioning every 2 hours 9 Braden 13 alternate positioning every 4 hours 14 Braden 17 No alternative of the positioning required but a friction and an evaluation of the cutaneous state every 6 hours
18 Braden 23 No alternative of the positioning required but a friction and an evaluation of the cutaneous state every 12 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02287-50 | OTHER | ANSM | None |