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

NCT ID: NCT03395795

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-13
• Study Completion Date: 2021-10-05

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.

Conditions

Infantile Spinal Muscular Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: OTHER

NAVA

Intervention Type: 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.

Interventions

NAVA

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aben Essid, MD

Role: STUDY_CHAIR

Service de pédiatrie, Hôpital Raymond Poincaré

Locations

Service de pédiatrie, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, France

Countries

France

Other Identifiers

IDRCB 2017-A02785-48

Identifier Type: OTHER

Identifier Source: secondary_id

P160941J

Identifier Type: -

Identifier Source: org_study_id