Status:
RECRUITING
Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
ARDS, Human
Obesity, Morbid
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test a personalized intervention aiming to optimize the mechanical ventilator settings in morbidly obese patients suffering from moderate to severe Acute Respirat...
Detailed Description
The goal of this clinical trial is to test a personalized intervention aiming to optimize the mechanical ventilator settings in morbidly obese patients suffering from moderate to severe Acute Respirat...
Eligibility Criteria
Inclusion
- 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 procedure with deferred consent
- Covid-19 and non-Covid-19 patients
Exclusion
- Contra-indication to nasogastric tube (uncontrolled coagulopathy, severe thrombocytopenia, 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
Key Trial Info
Start Date :
April 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 4 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06119516
Start Date
April 4 2024
End Date
July 4 2026
Last Update
May 3 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Angers
Angers, France, 49933
2
Hôpital Bicêtre, AP-HP
Le Kremlin-Bicêtre, France, 94270
3
Hôpital de la Croix-Rousse, HCL
Lyon, France, 69004
4
AP-HP, Hôpital Européen Georges Pompidou
Paris, France, 75015