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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT03395795
Eligibility Criteria:
Inclusion Criteria:
* Age above 1 year and under 18 years
* Patient hospitalized in the pediatric intensive care unit.
* Acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours.
* Patient with traditional NIV support less than 12 hours and still showing an indication for a non-invasive ventilatory support.
* Affiliation to the French health insurance organism
* Consent signed by the two holders of parental authority for the child participation in the research.
Exclusion Criteria:
* Contraindications to the use of NAVA or the setting up of a nasogastric tube.
* Hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine.
* Severe respiratory instability requiring imminent intubation or FiO2\> 60%, or PaCO2\> 80 mmHg.
* Limitation of life support treatments discussed or decided.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT03395795
Study Brief:
Protocol Section:
NCT03395795