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

NCT03395795 | Completed

• 2 other identifiers: P160941JIDRCB 2017-A02785-48
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Infantile Spinal Muscular Atrophy

Keywords

Infantile Spinal Muscular Atrophy; Respiratory Decompensations

Outcome Measures

Primary Outcomes (1)

• Asynchrony percentage

  Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.

  At baseline

Secondary Outcomes (7)

• Feasibility

  At baseline

• Feasibility

  At baseline

• Efficacy and tolerance

  At 30 minutes and 60 minutes

• Efficacy and tolerance

  At 30 minutes and 60 minutes

• Efficacy and tolerance

  At 30 minutes and 60 minutes

Study Arms (1)

Single arm

OTHER

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

Device: NAVA

Interventions

NAVA DEVICE

The study has 3 phases: 1. 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. 2. 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. 3. Phase 3: The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording.

Single arm

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de pédiatrie, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, 92380, France

Location

MeSH Terms

Conditions

Spinal Muscular Atrophies of Childhood

Condition Hierarchy (Ancestors)

Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aben Essid, MD

  Service de pédiatrie, Hôpital Raymond Poincaré

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 10, 2018
• Study Start: February 13, 2018
• Primary Completion: December 17, 2019
• Study Completion: October 5, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)