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

Mechanical Ventilation Clinical Trial

— MAPIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05515484
• Other study ID #: PI2021_843_0195
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: August 2023

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Pr Michel Slama, Pr
• Phone: 0322087841
• Email: slama.michel[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• Mechanical Ventilation
• Prone Position

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of Lung compliance between both groups		3 days