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

Condition(s) studied

Investigational drug(s) / intervention(s)

Esophageal pressure-guided strategy,: 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.

Study 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

Primary outcome measure(s)

• 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.

Trial sites (5)

More Assistance Publique - Hôpitaux de Paris trials in France

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