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Recruiting

NCT Number: NCT05515484

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Gilles Touati, Pr

SUB_INVESTIGATOR

Michel Slama, Pr

CONTACT

[email protected]

(33)3 22 08 78 41

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prone position with airbags

Other

prone position with airbags

prone position without airbags

Other

prone position without airbags

Primary outcomes

  1. variation of Lung compliance between both groups

    Time frame: 3 days

Study contacts

Contact information is provided by the study sponsor or research team.

Pr Michel Slama, Pr

CONTACT

[email protected]

0322087841

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: MAPIC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2022
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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