Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03395795
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE December 11, 2017
First Posted Date  ICMJE January 10, 2018
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE February 13, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
  • Feasibility [ Time Frame: At baseline ]
    Frequency of obtaining an EADi signal
  • Feasibility [ Time Frame: At baseline ]
    Percentage of effective time spent in activated NAVA mode
  • 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.
  • 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.
  • Efficacy and tolerance [ Time Frame: At 30 minutes and 60 minutes ]
    O2 saturation will be collected.
  • Efficacy and tolerance [ Time Frame: At 30 minutes and 60 minutes ]
    FiO2 after 30 and 60 minutes under each ventilation mode will be collected.
  • Rate of recourse to intubation [ Time Frame: At baseline ]
    Rate of recourse to intubation, patient preference.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
Official Title  ICMJE Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infantile Spinal Muscular Atrophy
Intervention  ICMJE 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.

Study Arms  ICMJE Single arm
Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation.
Intervention: Device: NAVA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aben Essid, MD + 33 (6) 17 77 66 52 aben.essid@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03395795
Other Study ID Numbers  ICMJE P160941J
IDRCB 2017-A02785-48 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Aben Essid, MD Service de pédiatrie, Hôpital Raymond Poincaré
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP