Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Esophageal pressure-guided strategy,

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Ministry of Health, France

Collaborator