NCT06119516Recruiting
Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 12 Oct 2023
- Start date
- Apr 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Obesity
- NCT number
- NCT06119516
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Apr 2024 to the primary completion date, Apr 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Order to limit life-sustaining therapy
Other
- Contra-indication to nasogastric tube (uncontrolled coagulopathy, severe thrombocytopenia, nasal trauma, esophageal varices)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Hôpital Bicêtre AP-HP Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| Hôpital de la Croix-Rousse, HCL Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| AP-HP Hopital Europeen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU la Miletrie Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.