Actively Recruiting
Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-21
40
Participants Needed
5
Research Sites
169 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 Respiratory Distress Syndrome (ARDS). The intervention consists of personalized measurements and calculations of the different pressures inside the thorax. The main question to answer is: • Will the evaluated esophageal pressure-guided strategy lead to different mechanical ventilator settings than suggested by a strategy largely used in ARDS patients in France? A specific nasogastric probe permitting to measure esophageal pressure will monitor participants. Esophageal pressure will act as an indicator of the pleural pressure. Other respiratory signals displayed by the mechanical ventilators will also be acquired. Further, ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, with possible benefit of this personalized approach.
CONDITIONS
Official Title
Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
CHU Angers
Angers, France, 49933
Actively Recruiting
2
Hôpital Bicêtre, AP-HP
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
3
Hôpital de la Croix-Rousse, HCL
Lyon, France, 69004
Actively Recruiting
4
AP-HP, Hôpital Européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
5
CHU la Milétrie
Poitiers, France, 86021
Actively Recruiting
Research Team
J
Joséphine Braun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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