Menu
Recruiting NCT05515484

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

Phase II Interventional ARDS Prone Position Mechanical Ventilation Airbag

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prone position with airbags, prone position without airbags.
Who it may be relevant to
Registry conditions: ARDS, Prone Position, Mechanical Ventilation, Airbag. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other prone position with airbags
    prone position with airbags
  • Other prone position without airbags
    prone position without airbags

Primary outcome measures

  • variation of Lung compliance between both groups [Time frame: 3 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU Amiens — Amiens

Identifiers

NCT: NCT05515484 · PI2021_843_0195

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗