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

NCT ID: NCT05515484

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS Prone Position Mechanical Ventilation Airbag

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prone position with airbags

Group Type EXPERIMENTAL

prone position with airbags

Intervention Type OTHER

prone position with airbags

prone position standard of care

Group Type ACTIVE_COMPARATOR

prone position without airbags

Intervention Type OTHER

prone position without airbags

Interventions

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prone position with airbags

prone position with airbags

Intervention Type OTHER

prone position without airbags

prone position without airbags

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pr Michel Slama, Pr

Role: CONTACT

0322087841

Facility Contacts

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Michel Slama, Pr

Role: primary

(33)3 22 08 78 41

Other Identifiers

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PI2021_843_0195

Identifier Type: -

Identifier Source: org_study_id

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