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 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT06400095
Eligibility Criteria:
Inclusion Criteria:
* Patients with Acute respiratory failure needing mechanical ventilation
* Diagnosis of Severe ARDS with severity: PF ratio \< 150, with PEEP/CPAP \> 5
Exclusion Criteria:
* r2 \< 0.95, monitored on the ventilator
* Expiratory flow that is not first-order or non-exponential decay
* Patients with Nor-epinephrine requirements \> 0.1 mcg/kg/min within 2 hours of intubation
* Patients requiring ECMO ( Extracorporeal membrane oxygenation)
* Patients with COPD or pulmonary fibrosis with a premorbid FEV1 \< 1.5 L
* Severe atherosclerotic vascular disease
* Patients with a chest tube, intra-abdominal hypertension or with its risk factors
* Patients with structural heart disease including pulmonary hypertension (RVSP \> 45) and heart failure
* All comfort care orders in the ICU
* Patients who underwent tracheostomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT06400095
Study Brief:
Protocol Section:
NCT06400095