NCT06119516 Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
| NCT ID | NCT06119516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | ARDS, Human |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2027-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-04-04 with a primary completion date of 2027-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Jean-Luc MD Diehl, PhD
STUDY CHAIR
AP-HP, Hôpital Européen Georges Pompidou, Paris
Frequently Asked Questions
Who can join the NCT06119516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ARDS, Human. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06119516 currently recruiting?
Yes, NCT06119516 is actively recruiting participants. Contact the research team at josephine.braun@aphp.fr for enrollment information.
Where is the NCT06119516 trial being conducted?
This trial is being conducted at Angers, France, Le Kremlin-Bicêtre, France, Lyon, France, Paris, France and 1 additional location.
Who is sponsoring the NCT06119516 clinical trial?
NCT06119516 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Jean-Luc MD Diehl, PhD at AP-HP, Hôpital Européen Georges Pompidou, Paris. The trial plans to enroll 40 participants.