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

Infantile Spinal Muscular Atrophy Clinical Trial

— NAVASI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395795
• Other study ID #: P160941J
• Secondary ID: IDRCB 2017-A0278
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: October 5, 2021

Study information

• Verified date: March 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 5, 2021
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Infantile Spinal Muscular Atrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal

Intervention

Device:
• NAVA
The study has 3 phases: Phase 1: The patient is connected to the SERVOi® ventilator in classic VNI mode, which is parameterized according to the patient's needs and then maintained for 30min for measurements. Phase 2: Switch to NAVA mode (1h). Definition of NAVA parameters: The positive expiratory pressure will not be modified. The NAVA level (the proportionality factor that converts the EADi (microV) to the pressure level in cmH2O was first adjusted according to the actual assisted pressure in the patient in the normal VNI mode. NAVA period: The ventilatory pressure, as well as the EADI is recorded continuously for 30min after a NAVA adaptation period of about 30min. Phase 3: The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording.

Locations

Country	Name	City	State
France	Service de pédiatrie, Hôpital Raymond Poincaré	Garches	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony percentage	Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.	At baseline
Secondary	Feasibility	Frequency of obtaining an EADi signal	At baseline
Secondary	Feasibility	Percentage of effective time spent in activated NAVA mode	At baseline
Secondary	Efficacy and tolerance	Efficacy and tolerance: during the whole of the study period (2h30), the monitoring of transcutaneous CO2 pressure (PtcCO2) will be collected.	At 30 minutes and 60 minutes
Secondary	Efficacy and tolerance	Efficacy and tolerance: during the whole of the study period (2h30), evolution of respiratory rate will be collected.	At 30 minutes and 60 minutes
Secondary	Efficacy and tolerance	O2 saturation will be collected.	At 30 minutes and 60 minutes
Secondary	Efficacy and tolerance	FiO2 after 30 and 60 minutes under each ventilation mode will be collected.	At 30 minutes and 60 minutes
Secondary	Rate of recourse to intubation	Rate of recourse to intubation, patient preference.	At baseline