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History of Changes for Study: NCT01570933
Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants. (NIVNAVA)
Latest version (submitted December 6, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 2, 2012 None (earliest Version on record)
2 December 6, 2013 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT01570933
Submitted Date:  April 2, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: SIP2011
Brief Title: Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants. (NIVNAVA)
Official Title: Feasibility Study Over the Neurally Adjusted Ventilatory Assist (NAVA) Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2012
Overall Status: Recruiting
Study Start: November 2011
Primary Completion: September 2012 [Anticipated]
Study Completion: September 2012 [Anticipated]
First Submitted: March 6, 2012
First Submitted that
Met QC Criteria:
April 2, 2012
First Posted: April 4, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 2, 2012
Last Update Posted: April 4, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
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.

Open or close this module Conditions
Conditions: Heart Defects, Congenital
Surgery
Keywords: cardio-pulmonary bypass
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 10 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. Comparison of breathing rhythm between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
[ Time Frame: from minute zero to minute 90 ]

2. 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 ]

3. Comparison of Inspiratory Pressure between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
[ Time Frame: from minute zero to minute 90 ]

4. Comparison of FiO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
[ Time Frame: from minute zero to minute 90 ]

5. Comparison of PaO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
[ Time Frame: from minute zero to minute 90 ]

6. Comparison of PaCO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
[ Time Frame: from minute zero to minute 90 ]

7. Comparison of blood pH between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
[ Time Frame: from minute zero to minute 90 ]

Open or close this module Eligibility
Minimum Age:
Maximum Age: 12 Months
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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)
Open or close this module Contacts/Locations
Central Contact Person: Laurent Houtekie, md
Telephone: +327642723
Email: laurent.houtekie@uclouvain.be
Central Contact Backup: Damien Moerman
Telephone: +327642723
Study Officials: Laurent Houtekie, md
Principal Investigator
Cliniques Universitaires Saint-LUc, Brussels
Locations: Belgium
Cliniques Univeristaires Saint-Luc
[Recruiting]
Brussels, Belgium, 1200
Contact:Contact: Laurent Houtekie, md +327642723 laurent.houtekie@uclouvain.be
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