Last updated: May 2, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting
Phase
N/A
Condition
Respiratory Failure
Lung Injury
Treatment
Esophageal pressure-guided strategy,
Clinical Study ID
NCT06119516
APHP220824
PHRC21-0254
2023-A01044-41
DR-2023-130
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult patient (aged 18 years or older)
- Class III morbid obesity (BMI > 40 kg/m2)
- Moderate or severe ARDS criteria (according to the Berlin definition)
- Less than 72 hours between fulfilling moderate or severe ARDS criteria and inclusion
- Tracheal intubation and invasive mechanical ventilation
- Informed consent (patient, next of kin), with possibility of an emergency procedurewith deferred consent
- Covid-19 and non-Covid-19 patients
Exclusion
Exclusion Criteria:
- Contra-indication to nasogastric tube (uncontrolled coagulopathy, severethrombocytopenia, nasal trauma, esophageal varices)
- Order to limit life-sustaining therapy
- ExtraCorporal Membrane Oxygenation (ECMO) in use
- Invasive mechanical ventilation > 96 hours
- Elevated intracranial pressure
- Active air-leak: pneumothorax, pneumomediastinum
- Pregnancy or breast feeding
- Patient on state medical aid
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Esophageal pressure-guided strategy,
Phase:
Study Start date:
April 04, 2024
Estimated Completion Date:
July 04, 2026
Study Description
Connect with a study center
CHU Angers
Angers, 49933
FranceActive - Recruiting
Hôpital Bicêtre, AP-HP
Le Kremlin-Bicêtre, 94270
FranceActive - Recruiting
Hôpital de la Croix-Rousse, HCL
Lyon, 69004
FranceActive - Recruiting
AP-HP, Hôpital Européen Georges Pompidou
Paris, 75015
FranceActive - Recruiting
CHU la Milétrie
Poitiers, 86021
FranceActive - Recruiting
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