Clinical trial NCT03395795: Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
Official title: Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Spinal Muscular Atrophy
Keywords: Infantile Spinal Muscular Atrophy
Respiratory Decompensations
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

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.

Primary outcomes:
measure: Asynchrony percentage
timeFrame: At baseline
Secondary outcomes:
measure: Feasibility
timeFrame: At baseline
measure: Feasibility
timeFrame: At baseline
measure: Efficacy and tolerance
timeFrame: At 30 minutes and 60 minutes
measure: Efficacy and tolerance
timeFrame: At 30 minutes and 60 minutes
measure: Efficacy and tolerance
timeFrame: At 30 minutes and 60 minutes
measure: Efficacy and tolerance
timeFrame: At 30 minutes and 60 minutes
measure: Rate of recourse to intubation
timeFrame: At baseline
Other outcomes:
Locations:
city: Garches
country: France
facility: Service de pédiatrie, Hôpital Raymond Poincaré
state: Hauts-de-Seine
Study officials:
affiliation: Service de pédiatrie, Hôpital Raymond Poincaré
name: Aben Essid, MD
role: STUDY_CHAIR
References: