Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants. (NIVNAVA)

December 6, 2013 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Feasibility Study Over the Neurally Adjusted Ventilatory Assist (NAVA) Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.

Neonates who underwent cardiac surgery with cardiopulmonary bypass almost always require non-invasive respiratory support (NIV) in relay to conventional ventilation. Current nasal interfaces do not generally allow synchronised bilevel ventilation. NIV-NAVA mode allows, through an oesophageal catheter, to record the electrical activity of the diaphragm and thereby synchronize breaths from the ventilator on the inspiratory efforts of the child. Moreover, the pressure support delivered by the ventilator may be proportional to the diaphragmatic effort developed by the child. This mode, associated with the interface Miniflow®, could increase the comfort of the child by allowing a more efficient synchronization and reducing its respiratory work. To our knowledge, this ventilation mode with this interface has not been evaluated in the postoperative period of cardiac surgery in the newborns. The purpose of this study is to evaluate the feasibility of this ventilatory mode and evaluate its influence on ventilatory parameters of this category of infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design:

Single centre prospective crossover study

Study Objectives:

Main objectives:

  • Assessment of the feasibility of non invasive ventilation in NIV-NAVA mode via Miniflow® interface in infants of less than 3.5 kg after cardiac surgery with cardiopulmonary bypass.

  • Evaluation of the following parameters:

    • Implementation of the interface
    • Air leaks
    • Placement and contention of oesophageal probe
    • Quality of synchronization
    • Obstruction of the probe
    • Risk of nasal wounds

Secondary objectives:

  • Comparison of ventilation parameters between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode

  • Evaluation of the following parameters:

    • Breathing rhythm
    • Tidal volume
    • PEEP
    • Inspiratory pressure
    • FiO2
    • PaO2
    • PaCO2
    • pH
  • Evolution of EAdi min and EAdi max parameters in NIV-NAVA mode (EAdi : diaphragmatic electric activity)

Conduct of the study:

First phase: placement of EADI catheter and extubation

When extubation criteria are met, the oesophageal EADI catheter is placed according to the manufacturer's instructions. The ventilation mode is then switched to Pressure Support Mode with the same Peep as in the previous mode and a pressure support of 10 cmH2O.

During 30 minutes, trends in respiratory rate, tidal volume, PEEP, inspiratory pressure, FiO2, EADI min, EADi max are recorded.

After 30 minutes, an arterial blood gas analysis is performed to determine the values of PaCO2, PaO2 and pH before randomization.

The child is extubated according to the procedures of the service and the non-invasive ventilation relay is introduced through the Miniflow® interface with nasal prongs adapted to the morphology of the child. An adrenaline nebulisation can be given before starting NIV in case of respiratory distress due to laryngeal oedema.

Second phase: nCPAP or NIV-NAVA

Following randomisation, the child is included in the "nCPAP first" arm or "NIV-NAVA first" arm and is ventilated in the designated mode for 30 minutes. During the first 15 minutes, the ventilation parameters are adapted according to the procedures below:

nCPAP parameters adaptation:

  • PEEP and FiO2 as previously set in invasive ventilation;
  • FiO2 according to target SpO2 values of the child and/or 10% higher than FiO2 in invasive ventilation mode;
  • PEEP between 4-6 cmH2O in order to minimize respiratory efforts.

NIV-NAVA parameters adaptation:

  • PEEP and FiO2 as previously set in invasive ventilation;
  • Adaptation of the NIV-NAVA level to reach a EADi level equal to the mean EADi level over the last 5 minutes of the invasive mode. Inspiratory pressure and tidal volume are limited respectively to 30 cmH2O and 8 ml/kg.
  • FiO2 according to target SpO2 values of the child and/or 10% higher than FiO2 in invasive ventilation mode ;
  • PEEP between 4-6 cmH2O in order to minimize respiratory efforts.

Over the last 15 minutes of this ventilation mode, trends in respiratory rate, tidal volume, PEEP, inspiratory pressure, FiO2, EADI min, EADi max are recorded.

On Minutes M16, M21 and M29 in NIV-NAVA mode, synchronisation data are recorded : auto-triggering, double triggering, inspiration beginning and ending.

After 30 minutes, an arterial blood gas analysis is performed to determine the evolution of the values of PaCO2, PaO2 and pH.

At any time, if the re-intubation criteria are met, the child is re-intubated and returned to conventional ventilation. He is then excluded of the study.

Third phase: nCPAP or NIV-NAVA

The ventilation mode is changed from nCPAP to NIV-NAVA or from NIV-NAVA to nCPAP. The adaptation protocol and the recorded parameters are the same as in the second phase.

After 30 minutes, an arterial blood gas analysis is performed to determine the evolution of the values of PaCO2, PaO2 and pH.

At any time, if the re-intubation criteria are met, the child is re-intubated and returned to conventional ventilation. He is then excluded of the study.

Fourth phase: end of the study

The study concludes at the end of the third phase. The child is left in the better tolerated ventilation mode, as judged by the clinician.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Univeristaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weight ≤ 5 kg
  • Postoperative period of cardiac surgery with cardiopulmonary bypass (max 10 days after surgery)
  • Conventional ventilation
  • Agreement with the extubation criteria
  • Arterial line

Exclusion Criteria:

  • High frequency oscillation ventilation
  • Extubation criteria not fulfilled
  • Proven or suspected sepsis
  • Absence of arterial line
  • Oesophageal pathology (Excepted gastro-oesophageal reflux)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NAVAfirst
Starting crossover by NIVnava mode
Device: NivNava
Non-invasive Nava ventilation mode on nasal cannula
Other Names:
  • Neurally adjusted ventilatory assist
ACTIVE_COMPARATOR: Cpap first
Start crossover by Cpap on nasal canula
Device: Cpap
nasal Cpap on nasal cannula
Other Names:
  • InfantFlow(R), CareFusion(R), SanDiego, Ca, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the percentage of asynchronies during the nava mode
Time Frame: from minute zero to minute 90
One of the aims of the NAVA mode is to provide better synchronization between the child's breathing needs and the breathing cycles given by the ventilator. By comparing the EDI curve (electric activity of the diaphragm of the child) and the flow and pressure curves of the ventilator, it is possible to determine the percentage of asynchronies during the nava mode
from minute zero to minute 90

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of breathing rhythm between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time Frame: from minute zero to minute 90
from minute zero to minute 90
Comparison of PEEP (positive end expiratory pressure) between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time Frame: from minute zero to minute 90
from minute zero to minute 90
Comparison of Inspiratory Pressure between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time Frame: from minute zero to minute 90
from minute zero to minute 90
Comparison of FiO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time Frame: from minute zero to minute 90
from minute zero to minute 90
Comparison of PaO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time Frame: from minute zero to minute 90
from minute zero to minute 90
Comparison of PaCO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time Frame: from minute zero to minute 90
from minute zero to minute 90
Comparison of blood pH between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time Frame: from minute zero to minute 90
from minute zero to minute 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Laurent Houtekie, md, Cliniques Universitaires Saint-Luc, Brussels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (ESTIMATE)

April 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIP2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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