About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Physiological lung recruitability assessment and PEEP titration protocol
Treatment groups
Locations
Sponsors and collaborators
Oriol Roca
Lead sponsor
Parc Taulí Hospital Universitari
Sponsor institution