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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
Hôpital Bicêtre, AP-HP
RECRUITING
Le Kremlin-bicêtre
Hôpital de la Croix-Rousse, HCL
RECRUITING
Lyon
AP-HP, Hôpital Européen Georges Pompidou
RECRUITING
Paris
CHU la Milétrie
RECRUITING
Poitiers
Contact Information
Primary
Joséphine Braun
josephine.braun@aphp.fr
01 44 84 17 38
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2026-07-04
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Collaborators: Ministry of Health, France
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov