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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01570933
First received: March 6, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Heart Defects, Congenital
Surgery
Device: NivNava
Device: Cpap
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study Over the Neurally Adjusted Ventilatory Assist (NAVA) Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Evaluation of the percentage of asynchronies during the nava mode [ Time Frame: from minute zero to minute 90 ] [ Designated as safety issue: No ]
    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:
  • Comparison of breathing rhythm between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode [ Time Frame: from minute zero to minute 90 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison of Inspiratory Pressure between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode [ Time Frame: from minute zero to minute 90 ] [ Designated as safety issue: No ]
  • Comparison of FiO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode [ Time Frame: from minute zero to minute 90 ] [ Designated as safety issue: No ]
  • Comparison of PaO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode [ Time Frame: from minute zero to minute 90 ] [ Designated as safety issue: No ]
  • Comparison of PaCO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode [ Time Frame: from minute zero to minute 90 ] [ Designated as safety issue: No ]
  • Comparison of blood pH between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode [ Time Frame: from minute zero to minute 90 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: November 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NAVAfirst
Starting crossover by NIVnava mode
Device: NivNava
Non-invasive Nava ventilation mode on nasal cannula
Other Name: Neurally adjusted ventilatory assist
Active Comparator: Cpap first
Start crossover by Cpap on nasal canula
Device: Cpap
nasal Cpap on nasal cannula
Other Name: InfantFlow(R), CareFusion(R), SanDiego, Ca, USA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01570933

Locations
Belgium
Cliniques Univeristaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Laurent Houtekie, md Cliniques Universitaires Saint-LUc, Brussels
  More Information

No publications provided

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01570933     History of Changes
Other Study ID Numbers: SIP2011
Study First Received: March 6, 2012
Last Updated: December 6, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
cardio-pulmonary bypass

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on July 31, 2014