Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06119516

Transpulmonary Pressure-Guided Mechanical Ventilation in Morbidly Obese Patients with Moderate to Severe ARDS: A Feasibility Study

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-21

40

Participants Needed

5

Research Sites

13 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

M

Ministry of Health, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate a personalized approach to adjusting mechanical ventilator settings in morbidly obese patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The study focuses on whether using esophageal pressure measurements to guide ventilator settings leads to different and potentially better settings compared to a commonly used strategy in France. It addresses a specific need for patients with class III obesity (BMI > 40 kg/m2), who have distinct respiratory pressure characteristics affecting lung and chest wall mechanics. Participants will be monitored using a specialized nasogastric probe called the Nutrivent catheter, which measures esophageal and gastric pressures for several days while also allowing enteral nutrition. These pressure measurements, along with other respiratory signals from the ventilator, will be used to personalize ventilator settings, especially the positive end-expiratory pressure (PEEP), to achieve slightly positive transpulmonary pressure at the end of expiration. This personalized strategy aims to optimize lung opening and avoid excessive lung inflation. During the study, participants will have continuous esophageal pressure monitoring through the catheter connected to the ventilator and data recording software. Researchers will assess how the personalized ventilator settings differ from standard care within the first 24 hours and monitor clinical outcomes such as oxygenation levels, mortality rates, days free from mechanical ventilation, and any complications like pneumothorax or hemodynamic issues. The study will include follow-up assessments up to 90 days, and participants' safety and comfort will be closely observed throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient aged 18 years or older
  • Class III morbid obesity with BMI over 40 kg/m2
  • Moderate or severe ARDS according to the Berlin definition
  • Less than 72 hours since meeting moderate or severe ARDS criteria
  • Currently intubated and on invasive mechanical ventilation
  • Informed consent obtained from patient or next of kin, including emergency deferred consent
  • Includes both Covid-19 and non-Covid-19 patients
Not Eligible

You will not qualify if you...

  • Contraindication to nasogastric tube such as uncontrolled bleeding disorder, severe thrombocytopenia, nasal trauma, or esophageal varices
  • Order to limit life-sustaining therapy
  • Use of Extracorporeal Membrane Oxygenation (ECMO)
  • Invasive mechanical ventilation longer than 96 hours
  • Elevated intracranial pressure
  • Active air leak like pneumothorax or pneumomediastinum
  • Pregnancy or breastfeeding
  • Patient receiving state medical aid

AI-Screening

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Your Study Journey

Screening

Duration - Up to 72 hours since meeting moderate or severe ARDS criteria

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Several days during invasive mechanical ventilation, up to 96 hours

Participants receive personalized mechanical ventilation settings guided by esophageal pressure measurements using a specialized catheter to optimize lung function and prevent complications.

Continuous monitoring during mechanical ventilation with catheter placement

Follow-up

Duration - Up to 90 days post intervention

Participants' outcomes including mortality, ventilation-free days, and complications are monitored after the intervention.

Visits at ICU discharge, Day 28, and Day 90

Trial Site Locations

Total: 5 locations

1

CHU Angers

Angers, France, 49933

Actively Recruiting

2

Hôpital Bicêtre, AP-HP

Le Kremlin-Bicêtre, France, 94270

Actively Recruiting

3

Hôpital de la Croix-Rousse, HCL

Lyon, France, 69004

Actively Recruiting

4

AP-HP, Hôpital Européen Georges Pompidou

Paris, France, 75015

Actively Recruiting

5

CHU la Milétrie

Poitiers, France, 86021

Actively Recruiting

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Research Team

J

Joséphine Braun

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Published Research Related To This Trial

Transpulmonary Pressure-Guided Lung-Protective Ventilation Improves Pulmonary Mechanics and Oxygenation Among Obese Subjects on Mechanical Ventilation.

Daniel D Rowley, Susan R Arrington, Kyle B Enfield...

https://pubmed.ncbi.nlm.nih.gov/33879565

Effect of Esophageal Pressure-guided Positive End-Expiratory Pressure on Survival from Acute Respiratory Distress Syndrome: A Risk-based and Mechanistic Reanalysis of the EPVent-2 Trial.

Todd Sarge, Elias Baedorf-Kassis, Valerie Banner-Goodspeed...

https://pubmed.ncbi.nlm.nih.gov/34464237