Informations générales (source: ClinicalTrials.gov)
Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
avril 2024
juillet 2026
17 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:38:10 | Contacter | |||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Angers - 49933 - Angers - France | Alain MD Mercat, PhD | Contact (sur clinicalTrials) | |||
| CHU la Milétrie - 86021 - Poitiers - France | Rémi MD Coudroy, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Bicêtre, AP-HP - 94270 - Le Kremlin-Bicêtre - France | Tài Olivier MD Pham, PhD | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix-Rousse, HCL - 69004 - Lyon - France | Jean-Christophe MD Richard, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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 procedure
with deferred consent
- Covid-19 and non-Covid-19 patients
- 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
- 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