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

NCT05515484 | Recruiting Phase 2

• 1 other identifier: PI2021_843_0195
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARDS; Prone Position; Mechanical Ventilation; Airbag

Keywords

ARDS; prone position; mechanical ventilation; airbag

Outcome Measures

Primary Outcomes (1)

• variation of Lung compliance between both groups

  3 days

Study Arms (2)

Prone position with airbags

EXPERIMENTAL

Other: prone position with airbags

prone position standard of care

ACTIVE COMPARATOR

Other: prone position without airbags

Interventions

prone position with airbags OTHER

prone position with airbags

Prone position with airbags

prone position without airbags OTHER

prone position without airbags

prone position standard of care

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Interventions

Prone Position; Air Bags

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Pr Michel Slama, Pr

CONTACT

0322087841; slama.michel@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: August 23, 2022
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)