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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05515484

Collaborator

(none)

Enrollment

Location

Arms

11.3

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS Prone Position Mechanical Ventilation Airbag	Other: prone position with airbags Other: prone position without airbags	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 23, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

variation of Lung compliance between both groups [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT05515484

Other Study ID Numbers:

PI2021_843_0195

First Posted:

Aug 25, 2022

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

ARDS

prone position

mechanical ventilation

airbag

Study Results

No Results Posted as of Aug 25, 2022