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

NCT01570933 | Completed Phase 4

• 1 other identifier: SIP2011
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital; Surgery

Keywords

cardio-pulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Evaluation of the percentage of asynchronies during the nava mode

  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 Outcomes (7)

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

  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

  from minute zero to minute 90

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

  from minute zero to minute 90

• Comparison of FiO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode

  from minute zero to minute 90

• Comparison of PaO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode

  from minute zero to minute 90

Study Arms (2)

NAVAfirst

EXPERIMENTAL

Starting crossover by NIVnava mode

Device: NivNava

Cpap first

ACTIVE COMPARATOR

Start crossover by Cpap on nasal canula

Device: Cpap

Interventions

NivNava DEVICE

Non-invasive Nava ventilation mode on nasal cannula

Also known as: Neurally adjusted ventilatory assist

NAVAfirst

Cpap DEVICE

nasal Cpap on nasal cannula

Also known as: InfantFlow(R), CareFusion(R), SanDiego, Ca, USA

Cpap first

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Univeristaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• Houtekie L, Moerman D, Bourleau A, Reychler G, Detaille T, Derycke E, Clement de Clety S. Feasibility Study on Neurally Adjusted Ventilatory Assist in Noninvasive Ventilation After Cardiac Surgery in Infants. Respir Care. 2015 Jul;60(7):1007-14. doi: 10.4187/respcare.03624. Epub 2015 Feb 17.

  PMID: 25691764 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Interactive Ventilatory Support; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Positive-Pressure Respiration

Study Officials

• Laurent Houtekie, md

  Cliniques Universitaires Saint-LUc, Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: April 4, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

BE (1)