Optimizing mechanical ventilation for morbidly obese patients with ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to personalize mechanical ventilator settings for morbidly obese patients suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS). It utilizes esophageal pressure measurements to guide adjustments in ventilator settings, potentially improving patient outcomes by preventing fluid accumulation in the lungs. The study will compare the effectiveness of this personalized approach against standard strategies used in ARDS management. Participants will be monitored using a nasogastric probe to measure esophageal pressure, which serves as an indicator of pleural pressure.

Why it matters

Who can join: the full rules

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's running

• CHU Angers
  Angers, France Recruiting
• Hôpital Bicêtre, AP-HP
  Le Kremlin-Bicêtre, France Recruiting
• Hôpital de la Croix-Rousse, HCL
  Lyon, France Recruiting
• AP-HP, Hôpital Européen Georges Pompidou
  Paris, France Recruiting
• CHU la Milétrie
  Poitiers, France Recruiting

Study contacts

• Study coordinator: Joséphine Braun
• Email: josephine.braun@aphp.fr
• Phone: 01 44 84 17 38

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.