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

April 20, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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). Mechanical ventilation is the cornerstone of the ARDS symptomatic treatment. Individualization of mechanical ventilator settings could improve prognosis mainly by preventing or decreasing accumulation of fluid in the lung and hemodynamic impairment. It is likely that class III obesity ARDS patients (defined by body mass index (BMI) > 40 kg/m2), could benefit from a highly personalized approach, based on esophageal pressure monitoring. These patients have significantly higher esophageal pressures, acting as an indicator of pleural pressure, than the general ARDS population, while these patients have rather normal mechanical characteristics of the chest wall. Such features could suggest innovative mechanical ventilator settings, by integrating esophageal pressures values, aiming to obtain a slightly positive transpulmonary pressure at the end of expiration.

The intervention consists of personalized measurements and calculations of the different pressures, including the esophageal one, inside the thorax.

The main question to answer is:

• Will the evaluated esophageal pressure-guided strategy lead to different mechanical ventilator settings, mainly the positive end-expiratory pressure (PEEP) setting, than suggested by a PEEP-strategy largely used in ARDS patients in France?

A specific nasogastric probe permitting to measure esophageal pressure will monitor participants. The second generation esogastric multifunction Nutrivent catheter (SIDAM, Mirandola, Italy) will be used. It allows both enteral nutrition of the patients and monitoring of esophageal and gastric pressures during several days. Esophageal pressure will act as an indicator of the pleural pressure. Other respiratory signals displayed by the mechanical ventilators will also be acquired, permitting to calculate the trans-pulmonary pressures.

Further, ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, with possible benefits of this personalized approach. The main benefits for the research participants will be the application of highly personalized mechanical ventilator settings, aiming mainly to select the best PEEP setting with the goal of optimization of opening the lung while avoiding the respiratory and hemodynamic consequences of excessive lung inflation. Monitoring of the end-inspiratory transpulmonary pressures will help to prevent excessive lung inflation.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • Chu Angers
        • Contact:
      • Le Kremlin-Bicêtre, France, 94270
        • Recruiting
        • Hôpital Bicêtre, AP-HP
        • Contact:
          • Tài Olivier MD Pham, PhD
          • Phone Number: 01 45 21 35 44
          • Email: tai.pham@aphp.fr
      • Lyon, France, 69004
      • Paris, France, 75015
        • Recruiting
        • AP-HP, Hôpital Européen Georges Pompidou
        • Contact:
      • Poitiers, France, 86021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esophageal pressure-guided strategy,
The second generation esogastric multifunction Nutrivent catheter (SIDAM, Mirandola, Italy) will be used to monitor esophageal and gastric pressures during several days. Ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, aiming to obtain a slightly positive transpulmonary pressure at the end of expiration.
Other: Esophageal pressure-guided strategy,
A catheter-balloon system will be positioned and calibrated in all included patients. The second generation esogastric multifunction Nutrivent catheter (SIDAM, Mirandola, Italy) will be used. It allows both enteral nutrition of the patients and monitoring of esophageal and gastric pressures during several days. A connection line will be inserted between the catheter (either esophageal or gastric balloon port) and the auxiliary pressure port of the mechanical ventilator (General Electric, R860, available in each center). Numeric recording of the respiratory signals will be achieved via the OhmedaCom Research Tool software, helping for centralization of the analyses, therefore ensuring reproducibility of the results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The absolute value of the difference between the PEEP levels determined by esophageal pressure-guided strategy and by the PEEP level indicated by the maximal recruitment arm of the ExPress trial
Time Frame: during the first 24 hours after inclusion
To demonstrate that the evaluated esophageal pressure-guided strategy leads to significantly and clinically different mechanical ventilator settings (mainly PEEP setting) than the reference strategy.
during the first 24 hours after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ratio between the arterial partial pressure of oxygen (PaO2) on the inspired fraction of oxygenFiO2): PaO2/FiO2 ratio
Time Frame: during the intervention
To assess the efficacy of the esophageal pressure-guided strategy.
during the intervention
The mortality rate of included patients.
Time Frame: Mortality rate will be determined at end of ICU stay, at Day 28 and at Day 90.
To assess the efficacy and safety of the esophageal pressure-guided strategy.
Mortality rate will be determined at end of ICU stay, at Day 28 and at Day 90.
Number of days alive and free for invasive mechanical ventilation
Time Frame: The numbers of days alive and free for invasive mechanical ventilationwill be determined at Day-28 and Day-90
To assess the efficacy of the esophageal pressure-guided strategy.
The numbers of days alive and free for invasive mechanical ventilationwill be determined at Day-28 and Day-90
Occurrence of pneumothorax
Time Frame: during the intervention
To assess the safety of the esophageal pressure-guided strategy.
during the intervention
Occurence of severe hemodynamic compromise defined by the need of vasoactive treatment
Time Frame: during the intervention
To assess the safety of the esophageal pressure-guided strategy.
during the intervention
Percentage of included patients with inability to insert the Nutrivent catheter
Time Frame: during the first 24 hours after inclusion
To assess the feasibility of the esophageal pressure-guided strategy.
during the first 24 hours after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: Jean-Luc MD Diehl, PhD, AP-HP, Hôpital Européen Georges Pompidou, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Estimated)

April 4, 2027

Study Completion (Estimated)

July 4, 2027

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220824
  • 2023-A01044-41 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)
  • PHRC21-0254 (Other Grant/Funding Number: French Ministry of health)
  • DR-2023-130 (Other Identifier: Commission Nationale de l'Informatique et des Libertés)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.

Processing of shared data must comply with European General Data Protection Regulation (GDPR).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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