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

Not Applicable

Recruiting

• Conditions: ARDS, Human; Obesity, Morbid
• Interventions: Other: Esophageal pressure-guided strategy,

• Registration Number: NCT06119516
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed 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 Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-07
• Study Start: 2024-04-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03
• Primary Completion: 2026-04-04
• Study Completion: 2026-07-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esophageal pressure-guided strategy,	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.

Primary Outcome Measures

Name	Time	Method
The absolute value of the difference between the PEEP levels determined by esophageal pressure-guided strategy and by the PEEP level indicated by the maximal recruitment arm of the ExPress trial	during the first 24 hours after inclusion	To demonstrate that the evaluated esophageal pressure-guided strategy leads to significantly and clinically different mechanical ventilator settings (mainly PEEP setting) than the reference strategy.

Secondary Outcome Measures

Name	Time	Method
The ratio between the arterial partial pressure of oxygen (PaO2) on the inspired fraction of oxygenFiO2): PaO2/FiO2 ratio	during the intervention	To assess the efficacy of the esophageal pressure-guided strategy.
Occurrence of pneumothorax	during the intervention	To assess the safety of the esophageal pressure-guided strategy.
Occurence of severe hemodynamic compromise defined by the need of vasoactive treatment	during the intervention	To assess the safety of the esophageal pressure-guided strategy.
The mortality rate of included patients.	Mortality rate will be determined at end of ICU stay, at Day 28 and at Day 90.	To assess the efficacy and safety of the esophageal pressure-guided strategy.
Number of days alive and free for invasive mechanical ventilation	The numbers of days alive and free for invasive mechanical ventilationwill be determined at Day-28 and Day-90	To assess the efficacy of the esophageal pressure-guided strategy.
Percentage of included patients with inability to insert the Nutrivent catheter	during the first 24 hours after inclusion	To assess the feasibility of the esophageal pressure-guided strategy.

Trial Locations

Locations (5)

CHU Angers; 🇫🇷 Angers, France

Hôpital Bicêtre, AP-HP; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital de la Croix-Rousse, HCL; 🇫🇷 Lyon, France

AP-HP, Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

CHU la Milétrie; 🇫🇷 Poitiers, France