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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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