Pilot Study for Evaluation of the Procedure Impact of Mobilization Adapted to Pressure Ulcer Risk for Patients in Intensive Care.

NCT03454230 | Completed

• 2 other identifiers: K171008J2017-A03038-45
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Pressure ulcers (PU) represent a major health issue because of their high incidence and of their important consequences. There is an important risk of pressure ulcer acquisition for ICU patient with acute organ failure. 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 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…).

Conditions

Pressure Ulcers; Nursing Cares; Decubitus Ulcer; Pressure Injury

Keywords

Intensive care unit; ICU; adult critical care patients; repositioning schedule; patient handling; practical nursing; nursing care; pressure ulcers; decubitus ulcers; pressure injury

Outcome Measures

Primary Outcomes (1)

• positioning schedule efficacy

  To assess efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by Braden scale in adult ICU, compared to usual PU prevention management (without schedule daily adapted to PU risk) at the 28th day, or when leaving ICU wall, or at death if it occurs before.

  28 days

Secondary Outcomes (4)

• Caregivers commitment to the standardized positioning schedule in adult ICU (1)

  28 days

• Caregivers commitment to the standardized positioning schedule in adult ICU (2)

  28 days

• nursing workload

  28 days

• clinical safety of the positioning schedule

  28 days

Study Arms (2)

Positioning schedule

EXPERIMENTAL

Applying repositioning schedule daily adapted to pressure ulcer risk assessed with Braden scale. Then, the nurse will applied oil for PU prevention and repositioning which frequency will be defined by the Braden score. The positions will be the semi-fowler 30-30, the half-sitting position with a 45° angle position and patient lying on their back with the head up with a 30° angle for ventilator associated pneumonia prevention. Repositioning schedule will be applied according to the daily medical prescription. When physician allows to sit the patient on a chair, this have to be done by raising feet on a stool. Therefore, patients will stay in that chair as long as defined by positioning schedule. When patient is returned to bed, same positions as described above will be used alternately. In the time of positioning care, oil usually used for PU prevention will be applied on the skin of the areas of high risk of PU (heels, sacrum, elbows, trochanter, knees) and bone projections.

Procedure: Positioning schedule

Common repositioning practice

NO INTERVENTION

pressure ulcer prevention cares are provided according to usual practice. Frequency and modality of positioning applied to the patients are collected.

Interventions

Positioning schedule PROCEDURE

Applying repositioning schedule daily adapted to pressure ulcer risk assessed with Braden scale. Then, the nurse will applied oil for PU prevention and repositioning which frequency will be defined by the Braden score. The positions will be the semi-fowler 30-30, the half-sitting position with a 45° angle position and patient lying on their back with the head up with a 30° angle for ventilator associated pneumonia prevention. Repositioning schedule will be applied according to the daily medical prescription. When physician allows to sit the patient on a chair, this have to be done by raising feet on a stool. Therefore, patients will stay in that chair as long as defined by positioning schedule. When patient is returned to bed, same positions as described above will be used alternately. In the time of positioning care, oil usually used for PU prevention will be applied on the skin of the areas of high risk of PU (heels, sacrum, elbows, trochanter, knees) and bone projections.

Also known as: Positioning; prevention of pressure ulcers; repositioning program

Positioning schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Information of the patient, or if it is not possible information of his relatives, or emergency procedure if contacting relatives is not possible. Consent document will then be signed by the patient as soon as he is able to do.

You may not qualify if:

• Under than 18 years;
• Pregnant woman;
• protected adult as defined by the law;
• Person without any health insurance;
• patient admitted in ICU for the multiple trauma management;

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Tenon, AP-HP

Paris, 75020, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• MEHAY Daisy, RN

  Service de réanimation médico chirurgicale, Hôpital Tenon (AP-HP), Paris

  PRINCIPAL INVESTIGATOR

• FARTOUKH Muriel, MD

  Service de réanimation médico chirurgicale, Hôpital Tenon (AP-HP), Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To assess efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by Braden scale on occurrence of pressure ulcer in adult ICU in comparison with the routine patient management (without positioning schedule adapted on PU risk) at the 28th day, or when leaving ICU wall, or at death if it occurs before.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 5, 2018
• Study Start: March 5, 2018
• Primary Completion: September 13, 2018
• Study Completion: October 30, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)