Prevention of Pressure Sores in the Prone Position in ARDS Patients

NCT03125421 | Completed

• 1 other identifier: 69HCL17_0039
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.

Conditions

Pressure Sores

Outcome Measures

Primary Outcomes (1)

• number of patients with a new pressure sore of any stage in any predetermined location

  New pressure sores are validated by the independent committee (2 persons) in charge of the analysis of the pictures performed in the patients. The whole body is pictured in 3 parts and specific locations will be analyzed, which are forehead, nose, eyes, chin, jaw, lips, thorax, breast, knee, iliac crest, foot extension area, and external genitalia in man. For each location a four-stage severity score of the pressure sore is assessed.

  day 7 after inclusion

Study Arms (2)

control period

OTHER

standard preventive methods of pressure sores in each center

Procedure: standard preventive methods of pressure sores

experimental period

EXPERIMENTAL

experimental multifaceted preventive methods of pressure sores

Procedure: experimental multifaceted preventive methods of pressure sores

Interventions

standard preventive methods of pressure sores PROCEDURE

During the control period, the following specific methods to prevent pressure sores in the prone position (in ARDS patients mechanically ventilated via tracheal route) will be these ongoing in each center and involve the following components: lower eyelid and ocular protection by any method, inclination of the body from the horizontal position, intermittent head mobilization to the right or to the left, and no use of specific device to prevent pressures sores at the head and/or thorax, and/or knees, and/or feet. The following nonspecific methods to prevent pressures sores will be performed at the discretion of each center according to its usual practice: mattress, upper eyelid protection, main devices securely fasten, arms position, abdomen supported or not, mouth care, enteral nutrition continued in the prone position, skin protection and/or massage.

control period

experimental multifaceted preventive methods of pressure sores PROCEDURE

During the experimental period, the following specific methods to prevent pressure sores in the prone position (in ARDS patients mechanically ventilated via tracheal route) will be systematically applied: lower eyelid protection by horizontal strap, ocular protection by methylcellulose, 15° inclination of the body from the horizontal position, intermittent head mobilization to the right or to the left every four hours, and use of specific device to prevent pressures sores at the head, thorax, knees, and feet. The following nonspecific methods to prevent pressures sores will be applied as in the control period described above except for the following: the abdomen will not be supported and the skin will not be protected.

experimental period

Eligibility Criteria

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

You may qualify if:

• years or more in age
• staying in Intensive Care Unit (ICU)
• Intubated
• mechanically ventilated
• severe ARDS defined as arterial Pressure in Oxygen (PaO2)/ Oxygen Inspired Fraction (FIO2) \< 150 mmHg with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FIO2 ≥ 0.60
• prone positioning indicated by the clinician in charge
• weight \< 140 kgs
• agreement to participate obtained from the confidence person of the patient
• affiliated to social protection insurance

You may not qualify if:

• contra-indication to the prone positioning
• person under legal protection
• pregnancy
• weight \> 140 kg
• tracheotomy
• extracorporeal membrane oxygenation (ECMO)
• Refusal to participate

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hopital Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• Gay L, Huot L, Yonis H, Valera S, Hraeich S, Matthieu D, Gacouin A, Ouisse C, Reignier J, Massard A, Quenot JP, Revol C, Robine A, Guillemault O, Bourdin G, Robert A, Lacherade JC, Perarder C, Badet M, Baboi L, Rabilloud M, Decullier E, Montagne E, Girard R, Arcuset C, Mevel J, de Montigny AM, Guerin C. A Bundle of Interventions to Prevent Pressure Ulcers During Prone Position in Adult Patients With Acute Respiratory Distress Syndrome: Results of a French Stepped-Wedge Randomized Controlled Trial. Nurs Crit Care. 2025 Jul;30(4):e70084. doi: 10.1111/nicc.70084.

  PMID: 40509643 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lucile Gay

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: April 16, 2018
• Primary Completion: January 11, 2021
• Study Completion: January 11, 2021
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)