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

Centre Hospitalier Universitaire, Amiens

Status and phase: Enrolling; Phase 2

Conditions: Prone Position; Airbag; Mechanical Ventilation; ARDS

Treatments: Other: prone position with airbags; Other: prone position without airbags

Study type: Interventional

Funder types: Other

Identifiers

NCT05515484

PI2021_843_0195

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Prone position with airbags

Experimental group

Treatment:

Other: prone position with airbags

prone position standard of care

Active Comparator group

Treatment:

Other: prone position without airbags