Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06119516

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionARDS, Human, Obesity, Morbid

Full registry 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

Treatments and study arms

Esophageal pressure-guided strategy,

Other

A catheter-balloon system will be positioned and calibrated in all included patients. 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. A connection line will be inserted between the catheter (either esophageal or gastric balloon port) and the auxiliary pressure port of the mechanical ventilator (General Electric, R860, available in each center). Numeric recording of the respiratory signals will be achieved via the OhmedaCom Research Tool software, helping for centralization of the analyses, therefore ensuring reproducibility of the results.

Primary outcomes

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 trialduring 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.