Optimizing mechanical ventilation for morbidly obese patients with ARDS
Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
NA · Assistance Publique - Hôpitaux de Paris · NCT06119516
This study is testing if adjusting breathing machine settings based on pressure measurements can help morbidly obese patients with severe lung problems breathe better than standard methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 5 sites (Angers and 4 other locations) |
| Trial ID | NCT06119516 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with class III morbid obesity and moderate to severe ARDS.
Not a fit: Patients with contraindications to nasogastric tubes or those on life-sustaining therapy limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved respiratory function and outcomes for morbidly obese patients with ARDS.
How similar studies have performed: While the approach of using esophageal pressure monitoring is innovative, similar studies have shown promise in optimizing mechanical ventilation strategies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ARDS, Human, Obesity, Morbid, Obesity, morbid, Mechanical Ventilation, Transpulmonary pressure