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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07307066
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years
* Receiving invasive mechanical ventilation via endotracheal intubation at the time of screening
* Initiation of invasive mechanical ventilation within the past 24 hours
* PaO₂/FiO₂ ≤ 200 mmHg on PEEP ≥ 8 cmH₂O or, if arterial blood gas is unavailable: SpO₂/FiO₂ ≤ 235 with SpO₂ ≤ 97%
* Chest imaging (chest X-ray or CT) showing bilateral pulmonary infiltrates not fully explained by pleural effusions, lobar collapse, or pulmonary nodules
* Respiratory failure not fully explained by cardiac failure or fluid overload
* Expected to require invasive mechanical ventilation for ≥ 72 hours after enrollment
Exclusion Criteria:
* Receipt of extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation at screening
* Chronic ventilator dependence, defined as ≥ 21 consecutive days of mechanical ventilation prior to the current admission
* Brain death or anticipated withdrawal of life-sustaining treatment within 72 hours
* Pregnancy
* Known neuromuscular disease affecting spontaneous respiratory effort
* Prisoners or individuals unable to provide informed consent or surrogate consent
* Simultaneous enrollment in another interventional ICU study
* Lack of digital infrastructure for real-time ventilator waveform acquisition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07307066
Study Brief:
Protocol Section:
NCT07307066