Heart Defects, CongenitalPhase 4NIVNAVANCT01570933
Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.
A Phase 4 study testing NivNava and Cpap in people with Heart Defects, Congenital and Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Heart Defects, Congenital, Surgery
- What is being tested?
- NivNava and Cpap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- High frequency oscillation ventilation
- Extubation criteria not fulfilled
- Proven or suspected sepsis
- Absence of arterial line
- Oesophageal pathology (Excepted gastro-oesophageal reflux)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Defects, Congenital, Surgery
- Being tested
- NivNava, Cpap
- Keywords
- cardio-pulmonary bypass
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivNavaDevice
Also called Neurally adjusted ventilatory assist
Non-invasive Nava ventilation mode on nasal cannula
CpapDevice
Also called InfantFlow(R), CareFusion(R), SanDiego, Ca, USA
nasal Cpap on nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| NAVAfirst | Experimental | Starting crossover by NIVnava mode Receives: Device: NivNava |
| Cpap first | Active comparator | Start crossover by Cpap on nasal canula Receives: Device: Cpap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: from minute zero to minute 90
Comparison of Inspiratory Pressure between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Measured: from minute zero to minute 90
Comparison of FiO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Measured: from minute zero to minute 90
Comparison of PaO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Measured: from minute zero to minute 90
Comparison of PaCO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Measured: from minute zero to minute 90
Comparison of blood pH between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Measured: from minute zero to minute 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Houtekie, md, Principal investigator, Cliniques Universitaires Saint-LUc, Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570933
- Sponsor's protocol ID
- SIP2011
- Acronym
- NIVNAVA
- Status last verified
- Dec 2013
- First submitted
- 6 Mar 2012
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25691764
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Over the Neurally Adjusted Ventilatory Assist (NAVA) Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.
- ClinicalTrials.gov ID
- NCT01570933
- Acronym / sponsor ID
- NIVNAVA / SIP2011
- Conditions
- Heart Defects, Congenital, Surgery
- Keywords
- cardio-pulmonary bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVAfirst | Experimental | Device: NivNavaStarting crossover by NIVnava mode |
| Cpap first | Active comparator | Device: CpapStart crossover by Cpap on nasal canula |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- High frequency oscillation ventilation
- Extubation criteria not fulfilled
- Proven or suspected sepsis
- Absence of arterial line
- Oesophageal pathology (Excepted gastro-oesophageal reflux)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivNavaAlso: Neurally adjusted ventilatory assistNon-invasive Nava ventilation mode on nasal cannula | Device | NAVAfirst |
| CpapAlso: InfantFlow(R), CareFusion(R), SanDiego, Ca, USAnasal Cpap on nasal cannula | Device | Cpap first |
Primary outcome
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
7 secondary outcomes
Comparison of breathing rhythm between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time frame: 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
Comparison of Inspiratory Pressure between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time frame: 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
Comparison of PaO2 between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time frame: 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
Comparison of blood pH between nasal Continuous Positive Airway Pressure (nCPAP) mode and NIV-NAVA mode
Time frame: from minute zero to minute 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Derived from this study: PubMed 25691764Houtekie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Houtekie, md principal investigator
Cliniques Universitaires Saint-LUc, Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NivNava and Cpap in people with Heart Defects, Congenital and Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the percentage of asynchronies during the nava mode (time frame: from minute zero to minute 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.