Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit

NCT04550182 | Completed

• 2 other identifiers: APHP1806742019-A02287-50
• Study Type: interventional
• Target: 1,232
• Locations: 1 country
• Sites: 1

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 failure(s). 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…).

Conditions

Pressure Ulcer; Ischemic; Ischemic Ulcer

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)

• The proportion of pressure ulcer at day 28

  To assess the efficacy of a positioning schedule whose frequency of positioning is adapted every day to pressure ulcer risk assessed by the Braden scale and to the clinical state of the patient in adult ICUs, compared to usual PU prevention management (without schedule daily adapted to PU risk) at the 28th day, or when leaving ICU, or at death if it occurs before. Efficacy of the procedure will be measured by the proportion of pressure ulcer at day 28 or at ICU discharge or death if it occurs before.

  Up to 28 days

Secondary Outcomes (8)

• Tolerance of a repositioning schedule in adult intensive care unit

  Up to 28 days

• Impact of repositioning schedule on the length of hospitalization in intensive care unit

  Up to 28 days

• Evaluate the applicability of a repositioning schedule and clinical barriers to patients' repositioning schedule

  Up to 28 days

• Risk factors for pressure ulcer on critically ill patients

  Up to 28 days

• Impact of a repositioning schedule on the time spent caring for alternate position procedure prevention in adult intensive care units

  Up to 28 days

Study Arms (2)

Individual positioning schedule

EXPERIMENTAL

Pressure ulcer prevention cares are provided according to the positioning schedule for every patient.

Procedure: Positioning schedule

Standard care

NO INTERVENTION

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

Interventions

Positioning schedule PROCEDURE

The Braden scale will be collected every morning. Patients' care will be friction and repositioning applied at a frequency defined by the Braden scale: 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. Positioning will alternate semi-lateral decubitus at 30, semi-Fowler 30° -30°, half-sitting position 45° with elevation of the lower limbs. A medical prescription as part of the daily reassessed care will ensure the absence of absolute contraindication to the mobilization or contraindication to certain positions.Friction will be performed during repositioning.

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

Individual positioning schedule

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old without legal protection;
• Invasive or non-invasive mechanical ventilation;
• Hospitalized in intensive care for less than 72 hours;

You may not qualify if:

• Patient admitted to intensive care unit for the multiple trauma management with spinal cord injury;
• Patient already included once in the study
• Person without any health insurance scheme or not benefiting from a social security scheme

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Réanimation Médico-chirurgicale. Hôpital Tenon, AP-HP

Paris, Île-de-France Region, 75020, France

Location

MeSH Terms

Conditions

Pressure Ulcer; Ischemia

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Daisy Mehay, Degree Nurse in intensive care

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• 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 the occurrence of pressure ulcer in adult ICUs, in comparison with the routine patients' management (without positioning schedule adapted on PU risk) at the 28th day, or when leaving ICU, or at death if it occurs before.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: September 16, 2020
• Study Start: April 22, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)