Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II (NAVASI)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Infantile Spinal Muscular Atrophy

Treatments

Device: NAVA

Study type

Interventional

Funder types

Other

Identifiers

NCT03395795

P160941J

IDRCB 2017-A02785-48 (Other Identifier)

Details and patient eligibility

About

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 electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient.

To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.

Full 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, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.

Enrollment

1 patient

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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.