Improvement of Lung and Thoracic Compliance in ARDS Patients in Prone Position by Using Inflatable Air Bag (MAPIC)

ARDS is frequent in ICU and may lead to many complications and to death. Prone position is widely used in ADRS patients and demonstrated to decrease mortality. Regarding the chest wall compliance data are missing but the theorical response is that this compliance is decreased in a prone position mainly due to anterior chest and abdomen compression in this position which are more compliant that dorsal part of the body. As well prone position could be associated with complications as pressure ulcers. Because prone position is associated with complications, air bag were developped to decrease pressure on the chest and abdomen and to decrease pressure ulcers. Then, trying to improve chest compliance in prone position and reducing the risk of pressures ulcers could be a challenge with this system in comparison with standard care.

Study Overview

• Status: Recruiting
• Conditions: ARDS; Mechanical Ventilation; Prone Position; Airbag
• Intervention / Treatment: Other: prone position with airbags; Other: prone position without airbags

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pr Michel Slama, Pr; Phone Number: 0322087841; Email: slama.michel@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • Recruiting
    • CHU Amiens
    • Sub-Investigator: Gilles Touati, Pr
    • Contact: Michel Slama, Pr; Phone Number: (33)3 22 08 78 41; Email: slama.michel@chu-amiens.fr

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• patients with ARDS under mechanical ventilation with P/F ratio<150
• Age >18 y/o
• Admitted in the medical ICU of Amiens under mechanical ventilation sedated,
• With signed informed consent (patient or relative if patient is not conscious)

Exclusion Criteria:

• patients not eligible for a prone position
• Patients with tracheostomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prone position with airbags	Other: prone position with airbags; prone position with airbags
Active Comparator: prone position standard of care	Other: prone position without airbags; prone position without airbags

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
variation of Lung compliance between both groups	3 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: mechanical ventilation; ARDS; prone position; airbag
• Other Study ID Numbers: PI2021_843_0195

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