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:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT03237806
Eligibility Criteria:
Inclusion Criteria:
1. ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour period:
1. Requires positive pressure ventilation through an endotracheal tube
2. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a duration of no more than 7 days
3. PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP) at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7 days
4. No clinical evidence of left atrial hypertension (2) Hemodynamics stable (dopamine \<10ug/kg•min or norepinephrine \<10ug/kg)
2. Surgical patient Surgical patient requires positive pressure ventilation through an endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine \<10ug/kg•min or norepinephrine \<10ug/kg)
Exclusion Criteria:
* Age younger than 18 years or older than 85 years
* Cardiac failure
* Known pregnancy
* Increased intracranial pressure
* Severe neuromuscular disease
* Recent injury or other pathologic condition of the esophagus
* Pneumothorax
* Pleural effusion
* Diaphragmatic hernia
* Severe chronic respiratory disease
* End-stage chronic organ failure
* Expected survival of less than 24 hours
* Participation in another interventional study
* Attending physician declines to give consent for participant to enroll
* Patient or surrogate declines or is unable to give consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03237806
Study Brief:
Protocol Section:
NCT03237806