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

Not Applicable

Completed

• Conditions: Infantile Spinal Muscular Atrophy
• Interventions: Device: NAVA

• Registration Number: NCT03395795
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Study Start: 2018-02-13
• Primary Completion: 2019-12-17
• Study Completion: 2021-10-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	NAVA	Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation.

Primary Outcome Measures

Name	Time	Method
Asynchrony percentage	At baseline	Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.

Secondary Outcome Measures

Name	Time	Method
Feasibility	At baseline	Percentage of effective time spent in activated NAVA mode
Efficacy and tolerance	At 30 minutes and 60 minutes	FiO2 after 30 and 60 minutes under each ventilation mode will be collected.
Rate of recourse to intubation	At baseline	Rate of recourse to intubation, patient preference.

Trial Locations

Locations (1)

Service de pédiatrie, Hôpital Raymond Poincaré; 🇫🇷 Garches, Hauts-de-Seine, France