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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03395795
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Infantile Spinal Muscular Atrophy Device: NAVA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
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:

  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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03395795

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Contact: Aben Essid, MD + 33 (6) 17 77 66 52

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Service de pédiatrie, Hôpital Raymond Poincaré Recruiting
Garches, Hauts-de-Seine, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Study Chair: Aben Essid, MD Service de pédiatrie, Hôpital Raymond Poincaré
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT03395795    
Other Study ID Numbers: P160941J
IDRCB 2017-A02785-48 ( Other Identifier: ANSM )
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Infantile Spinal Muscular Atrophy
Respiratory Decompensations
Additional relevant MeSH terms:
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Muscular Atrophy
Muscular Atrophy, Spinal
Spinal Muscular Atrophies of Childhood
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Neuromuscular Diseases
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn