COMPARISON OF LUNG RECRUITABILITY ASSESSMENT BY HYSTERESIS RATIO AND RECRUITMENT-TO-INFLATION RATIO, AND PEEP TITRATION IN ARDS.
Starting soon · Not applicable
Conditions studied: Acute Respiratory Distress Syndrome (ARDS)
In brief
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.
Key facts
- Study ID
- NCT07713420
- Run by
- Oriol Roca
- People needed
- 30
- Starts
- 2026-07-01
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Intubated patients with acute respiratory distress syndrome (ARDS): PaO2/FiO2 ratio <200, with bilateral infiltrates of non-cardiogenic origin, with a PEEP of at least 5 cmH2O.
- The patient is receiving mechanical ventilation and continuous sedation.
- The patient has an esophageal balloon.
- Written informed consent signed and dated by the patient or one relative in case the patient is unable to consent, after a full explanation of the study by the investigator and prior to study participation
You may not qualify if…
- Patients with< 18 years old
- Pregnant woman
- Lung recruitment maneuvers are deemed unsafe by the medical team
- Unable to fit EIT belt due to patient size
- Contraindications to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)
- Hemodynamic instability (Systolic BP < 75 mmHg or MAP < 60 mmHg despite vasopressors and/or heart rate < 55 bpm)
- Hypernatremia (Na+ >145mEq/L)
- The formalized ethical decision to withhold or withdraw life support
- Patient under guardianship
- Patients deprived of liberties
- Impossibility to give informed consent by both patient and family (i.e. language barrier)
- Patient was already enrolled in the present study in a previous episode of acute respiratory failure.
Full record on ClinicalTrials.gov
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