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
This trial does not accept healthy volunteersQualifiers
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
Sequential
Treatments tested in this trial
Physiological lung recruitability assessment and PEEP titration protocol
Procedure/SurgeryParticipants undergo a standardized physiological protocol including lung recruitability assessment using the recruitment-to-inflation ratio and pressure-volume loop hysteresis ratio, a standardized lung recruitment maneuver, a decremental PEEP trial, and crossover evaluation of four PEEP titration strategies based on transpulmonary pressure, electrical impedance tomography, respiratory system compliance, and the recruitment-to-inflation ratio. The order of the recruitability assessments and PEEP titration strategies is randomized.
Treatment groups
Trial outcomes
Primary outcomes
Agreement between the hysteresis ratio and the recruitment-to-inflation (R/I) ratio for assessing lung recruitability
Agreement between lung recruitability assessed by the hysteresis ratio obtained from the pressure-volume loop and the recruitment-to-inflation (R/I) ratio, using the reduction in lung collapse measured by electrical impedance tomography (EIT) during the recruitment maneuver as the reference standard.
Secondary outcomes
Agreement between PVloop30 and PVloop40 for the assessment of lung recruitability
Comparison of lung recruitability assessment obtained from the hysteresis ratio measured using a low-flow pressure-volume loop with a maximum inflation pressure of 30 cmH₂O (PVloop30) and 40 cmH₂O (PVloop40), to determine whether a lower-pressure PV loop provides comparable information on lung recruitability
Respiratory mechanics and ventilation/perfusion (V/Q) changes according to different PEEP titration methods
Comparison of respiratory mechanics and ventilation/perfusion (V/Q) distribution between four different PEEP titration strategies: transpulmonary pressure-guided PEEP, electrical impedance tomography-guided PEEP, recruitment-to-inflation ratio-guided PEEP, and respiratory system compliance-guided PEEP.
Locations
Sponsors and contacts
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Oriol Roca
Lead sponsor
Parc Taulí Hospital Universitari
Sponsor institution
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