Status:
COMPLETED
Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Infantile Spinal Muscular Atrophy
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the ...
Detailed Description
This is a prospective, interventional, sequential, open-label research involving ASI II children with acute respiratory decompensation requiring ventilatory support by NIV. Airway pressure, transcutan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03395795
Start Date
February 13 2018
End Date
October 5 2021
Last Update
March 29 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service de pédiatrie, Hôpital Raymond Poincaré
Garches, Hauts-de-Seine, France, 92380