Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants. (NIVNAVA)
This study is currently recruiting participants.
Verified April 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01570933
First received: March 6, 2012
Last updated: April 2, 2012
Last verified: April 2012
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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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570933
Contacts
| Contact: Laurent Houtekie, md | +327642723 | laurent.houtekie@uclouvain.be |
| Contact: Damien Moerman | +327642723 |
Locations
| Belgium | |
| Cliniques Univeristaires Saint-Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Contact: Laurent Houtekie, md +327642723 laurent.houtekie@uclouvain.be | |
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: | April 2, 2012 |
| 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 May 16, 2013