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NCT Number: NCT03395795

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.

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Key information

Conditions

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

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de pédiatrie, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NAVA

Device

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.

Primary outcomes

  1. Asynchrony percentage

    Time frame: At baseline

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

Secondary outcomes

  1. Feasibility

    Time frame: At baseline

    Frequency of obtaining an EADi signal

  2. Feasibility

    Time frame: At baseline

    Percentage of effective time spent in activated NAVA mode

  3. Efficacy and tolerance

    Time frame: At 30 minutes and 60 minutes

    Efficacy and tolerance: during the whole of the study period (2h30), the monitoring of transcutaneous CO2 pressure (PtcCO2) will be collected.

  4. Efficacy and tolerance

    Time frame: At 30 minutes and 60 minutes

    Efficacy and tolerance: during the whole of the study period (2h30), evolution of respiratory rate will be collected.

  5. Efficacy and tolerance

    Time frame: At 30 minutes and 60 minutes

    O2 saturation will be collected.

  6. Efficacy and tolerance

    Time frame: At 30 minutes and 60 minutes

    FiO2 after 30 and 60 minutes under each ventilation mode will be collected.

  7. Rate of recourse to intubation

    Time frame: At baseline

    Rate of recourse to intubation, patient preference.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: NAVASI

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jan 10, 2018
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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