Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06119516
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Joséphine Braun
Phone 01 44 84 17 38
Email josephine.braun@aphp.fr
Status Recruiting
Phase N/A
Start date April 4, 2024
Completion date July 4, 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04517591 - Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT01550601 - Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity N/A
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Completed NCT03339791 - Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial N/A
Recruiting NCT05711758 - Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
Not yet recruiting NCT04209842 - Effectiveness Gastric Balloon in Obese Adolescents N/A
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02590406 - EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation N/A
Completed NCT01840020 - BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
Completed NCT01183975 - Swedish Adjustable Gastric Banding Observational Cohort Study N/A
Completed NCT03872024 - Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients N/A
Terminated NCT05993169 - Body Composition Optimization Intervention RCT N/A
Not yet recruiting NCT05974995 - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer N/A
Recruiting NCT05554016 - The UFO (Ultra Processed Foods in Obesity) Project
Completed NCT05519423 - Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals N/A
Not yet recruiting NCT05499949 - The Franciscus Obesity NASH Study