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:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT07121257
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Invasive mechanical ventilation via endotracheal tube.
* Diagnosis of moderate ARDS according to the Berlin Definition (PaO₂/FiO₂ between 150 and 200 mmHg with PEEP ≥ 5 cmH₂O).
* Lung-protective ventilation strategy prior to inclusion (VT ≤ 6 mL/kg PBW, PEEP titrated to transpulmonary pressure 0-2 cmH₂O).
* Deep sedation with RASS score of -5 at the time of inclusion.
* Informed consent obtained from the patient's legal representative.
Exclusion Criteria:
* Known obstructive pulmonary disease (e.g., COPD, asthma).
* Severe hemodynamic instability or uncontrolled shock.
* Pregnancy.
* Do-not-resuscitate (DNR) orders or limitations of life support.
* Anticipated need for ECMO in the next 24 hours.
* Presence of pneumothorax or bronchopleural fistula.
* Contraindications to esophageal pressure monitoring.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07121257
Study Brief:
Protocol Section:
NCT07121257