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

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

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.

Study Overview

• Status: Completed
• Conditions: Infantile Spinal Muscular Atrophy
• Intervention / Treatment: Device: NAVA

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts-de-Seine
    • Garches, Hauts-de-Seine, France, 92380
      • Service de pédiatrie, Hôpital Raymond Poincaré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asynchrony percentage	Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Frequency of obtaining an EADi signal	At baseline
Feasibility	Percentage of effective time spent in activated NAVA mode	At baseline
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
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
Efficacy and tolerance	O2 saturation will be collected.	At 30 minutes and 60 minutes
Efficacy and tolerance	FiO2 after 30 and 60 minutes under each ventilation mode will be collected.	At 30 minutes and 60 minutes
Rate of recourse to intubation	Rate of recourse to intubation, patient preference.	At baseline

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Aben Essid, MD, Service de pédiatrie, Hôpital Raymond Poincaré

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2018
• Primary Completion (ACTUAL): December 17, 2019
• Study Completion (ACTUAL): October 5, 2021

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (ACTUAL): January 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Infantile Spinal Muscular Atrophy; Respiratory Decompensations
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Motor Neuron Disease; Muscular Atrophy; Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood
• Other Study ID Numbers: P160941J; IDRCB 2017-A02785-48 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No