Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04924920
Eligibility Criteria:
* Adult (\>18 yo) ICU patients undergoing PSV ventilation
* Inspiratory support level (PS) between 8 and 15 cmH2O and positive end-expiratory pressure (PEEP) between 5 and 12 cmH2O,
* Presence of acute circulatory failure defined as:
* Systolic blood pressure (SBP) ≤90 mmHg or mean arterial pressure (MAP) ≤70 mmHg or requiring vasopressors to maintain SBP \>90 mmHg or MAP \>70 mmHg or decline of SBP \> 50 mm Hg in known hypertensive patients, along with one or more of the following:
* urinary flow ≤0.5 mL/kg/min for ≥2 hours
* heart rate ≥100 beats per minute
* presence of skin mottling and 4) blood lactate concentration ≥4 mmol/L.
Exclusion criteria
* left ventricular ejection fraction \<30% or severe valvular dysfunction
* atrial fibrillation
* severe acute respiratory distress syndrome (ARDS)
* abdominal compartment syndrome
* air leakage through chest drains
* artifacts in arterial waveform
* pathological respiratory patterns due to neurological diseases
* signs of fatigue or respiratory distress
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04924920
Study Brief:
Protocol Section:
NCT04924920