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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT04581668
Eligibility Criteria:
Inclusion Criteria:
1. admission to the pediatric intensive care unit:
* after Glenn, Fontan, Fallot Tetralogy surgery
* or after other types of surgery with risk of post-operative occurence of right ventricular failure or low lung output
2. invasive ventilation scheduled for at least 2 hours after admission
Exclusion Criteria:
* Contraindication to placement of a nasogastric NAVA tube
* History of significant focal brain injury (infarction or hemorrhage)
* Bilateral phrenic paralysis
* Extubation in operating room or planned to be within the hour,
* Patient with open chest, uncontrolled shock, need for neuromuscular blockade. Note that for these criteria, the patient may become eligible when these criteria are resolved.
* Patients for whom an acute care limitation order is in place.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
18 Years
Study:
NCT04581668
Study Brief:
Protocol Section:
NCT04581668