Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05515484

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-28

30

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute Respiratory Distress Syndrome (ARDS) is common in intensive care units and can cause serious complications and death. The prone position is often used for ARDS patients and has been shown to reduce mortality. However, its effect on chest wall compliance is not well understood, and the prone position may lower compliance due to compression of the chest and abdomen, which are usually more flexible in other positions. Additionally, prone positioning can cause pressure ulcers, leading to the development of airbags to reduce chest and abdomen pressure and possibly improve chest compliance. This study compares the use of inflatable airbags in the prone position to standard care without airbags for patients with ARDS on mechanical ventilation. Participants will be randomly assigned to either the experimental group using airbags or the control group receiving standard prone positioning care. The study aims to evaluate lung compliance changes over three days between these two approaches. Participants are adults admitted to the medical ICU with ARDS requiring mechanical ventilation and a P/F ratio below 150. The study involves monitoring lung compliance changes over three days while patients remain sedated and ventilated. Researchers will assess the variation in lung compliance between groups as the primary outcome. Safety and complications such as pressure ulcers will also be observed during the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with ARDS under mechanical ventilation with P/F ratio below 150
  • Age 18 years or older
  • Admitted in the medical ICU under mechanical ventilation and sedated
  • Signed informed consent from patient or relative if patient is unconscious
Not Eligible

You will not qualify if you...

  • Patients not eligible for prone positioning
  • Patients with tracheostomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 days

Participants are placed in a prone position with or without inflatable airbags to evaluate lung and thoracic compliance.

Daily visits during treatment

Trial Site Locations

Total: 1 location

1

CHU Amiens

Amiens, France, 80480

Actively Recruiting

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Research Team

P

Pr Michel Slama, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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