Prevention of Pressure Sores in the Prone Position in ARDS Patients (PSA)

A Nursing Strategy to Prevent Pressure Sores in the Prone Position in ARDS Patients. A Multicenter Controlled Prospective Stepped Wedge Trial

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.

Study Overview

• Status: Completed
• Conditions: Pressure Sores
• Intervention / Treatment: Procedure: standard preventive methods of pressure sores; Procedure: experimental multifaceted preventive methods of pressure sores

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon - Hôpital Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control period; standard preventive methods of pressure sores in each center	Procedure: standard preventive methods of pressure sores; 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.
Experimental: experimental period; experimental multifaceted preventive methods of pressure sores	Procedure: experimental multifaceted preventive methods of pressure sores; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Lucile Gay, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer
• Other Study ID Numbers: 69HCL17_0039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No