When could airway plateau pressure above 30 cmH2O be acceptable in ARDS patients?
Jean-Luc Diehl, Daniel Talmor
https://pubmed.ncbi.nlm.nih.gov/34236478Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-21
40
Participants Needed
5
Research Sites
13 weeks
Total Duration
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
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
Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.
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Complete this quick 3-step screening to check your eligibility
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)
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
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
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
J
Joséphine Braun
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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