Clinical Trial

COMPARISON OF LUNG RECRUITABILITY ASSESSMENT BY HYSTERESIS RATIO AND RECRUITMENT-TO-INFLATION RATIO, AND PEEP TITRATION IN ARDS.

Study acronym: PV-TOOL
Not Yet Recruiting
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Summary
This multicenter, single-blind physiological study aims to compare two bedside methods for assessing lung recruitability in mechanically ventilated patients with acute respiratory distress syndrome (ARDS): the recruitment-to-inflation (R/I) ratio and the pressure-volume (PV) loop hysteresis ratio. Lung recruitability will be defined according to the reduction in lung collapse measured by electrical impedance tomography (EIT) during a standardized lung recruitment maneuver. Following baseline measurements, participants will undergo sequential physiological assessments, including lung recruitability evaluation using both the R/I ratio and a low-flow PV loop, a standardized lung recruitment maneuver with a decremental PEEP trial, and a second PV loop performed at a lower maximum inflation pressure. The order of the R/I ratio assessment and the PV loop maneuver will be randomized. In a final crossover phase, four different PEEP titration strategies will be evaluated in randomized order. Each strategy will be applied for 15 minutes and separated by a washout period at the patient's baseline clinical PEEP. Respiratory mechanics, gas exchange, ventilation/perfusion distribution, and hemodynamic variables will be assessed throughout the protocol. The primary objective is to determine the agreement between the hysteresis ratio and the R/I ratio for identifying lung recruitability. Secondary objectives include evaluating whether a PV loop performed with a lower maximum pressure provides similar information on recruitability and comparing the physiological effects of different PEEP titration strategies. Approximately 30 patients with moderate-to-severe ARDS receiving invasive mechanical ventilation will be enrolled.
Trial Details
NCT Number NCT07713420
Lead Sponsor Oriol Roca
Conditions Acute Respiratory Distress Syndrome (ARDS)
Enrollment 30 participants
Start Date 2026-07
Primary Completion 2028-07 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-20