Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
Recruiting · NCT06119516 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Exclusion criteria
- 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
Where it is running
5 locations listed.
- CHU Angers - Angers, France
- Hôpital Bicêtre, AP-HP - Le Kremlin-Bicêtre, France
- Hôpital de la Croix-Rousse, HCL - Lyon, France
- AP-HP, Hôpital Européen Georges Pompidou - Paris, France
- CHU la Milétrie - Poitiers, France