Respiratory FailureNAVANCT03180385
NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
A study testing Neurally-Adusted Ventilatory Assist (NAVA) and Biphasic Positive Airway Pressure Support (BiPAP) in people with Respiratory Failure, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to providing respiratory… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Neurally-Adusted Ventilatory Assist (NAVA) and Biphasic Positive Airway Pressure Support (BiPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 10 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Postoperative cardiac surgery patients admitted to the Cardiovascular Care Center (CVCC) at Children's Hospitals and Clinics of Minnesota
- Recommended for non-invasive (NIV) respiratory support following extubation, per provider discretion
- 0 to 12 months of age
Who cannot join
- Documented airway malformation (congenital or acquired)
- Laryngomalacia
- Bronchomalacia
- Laryngeal web
- Tracheal or bronchial rings (complete or incomplete)
- Documented ENT abnormality
Show all 13Show fewer
- Documented central apnea
- Patients who are overly sedated, per provider discretion
- Tracheostomy in place at time of cardiac surgery
- Documented phrenic nerve paralysis (Note: Vocal cord paresis and paralysis will not be an exclusion)
- Other chromosomal abnormality (non-Down syndrome)
- Chronic lung disease
- Pre-operative non-invasive respiratory support
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
About this study
Official title: Neurally Adjusted Ventilatory Assist (NAVA) Versus Conventional Biphasic Positive End Expiratory Pressure (BiPAP) Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to providing respiratory support post-operatively. The investigators hypothesize that providing synchronized biphasic support with NAVA will be associated with shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive either NAVA or BiPAP following their cardiothoracic surgery.
Read the detailed description
Mechanical ventilation is often very necessary in the care of critically ill pediatric patients. However, it comes with many different complications that include chronic lung disease, tissue damage, and ventilator-associated pneumonia. Over time, we have increased our understanding of how a child's physiology interacts with a ventilator and this has led to two different non-invasive forms of respiratory support: bilevel positive air pressure (BiPAP) and neurally adjusted ventilator assist (NAVA). While both modalities come with a lot of benefits such as improved gas exchange, decreased respiratory and heart rate and decreased inspiratory work of breathing, NAVA has the ability to provide synchronous ventilatory support due to the electrical activity of the diaphragm.
The purpose of this study is to compare clinical outcomes following use of NAVA versus BiPAP in patients undergoing cardiac surgery, Specifically, comparisons of non-invasive respiratory support, duration of sedation, and length of hospital stay. The investigators hypothesize that the use of NAVA will lead to a shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay compared to the use of BiPAP.
This is a single-site, prospective randomized study. Subjects are randomized into two arms: those who receive NAVA and those who receive BiPAP post-operatively.
Subjects will be followed for up to 14 days post-operatively or until they are discharged, whichever comes first. Pain medication administered, FLACC (Face, Legs, Activity, Cry, Consolability), and SBS (State Behavioral Scale) scores are recorded daily for up to 14 days.
- Conditions
- Respiratory Failure
- Being tested
- Neurally-Adusted Ventilatory Assist (NAVA), Biphasic Positive Airway Pressure Support (BiPAP)
- Keywords
- NAVA, BiPAP, Pediatrics, Cardiac Surgery
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally-Adusted Ventilatory Assist (NAVA)Device
Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
Biphasic Positive Airway Pressure Support (BiPAP)Device
Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
| Study group | Role | What they receive |
|---|---|---|
| Neurally-Adjusted Ventilatory Assist (NAVA) | Experimental | Synchronized biphasic non-invasive respiratory support Receives: Device: Neurally-Adusted Ventilatory Assist (NAVA) |
| Biphasic Positive Airway Pressure Support (BiPAP) | Active comparator | Conventional non-invasive respiratory support Receives: Device: Biphasic Positive Airway Pressure Support (BiPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Post-operative Midazolam Dose
Measured: Up to 14 days post-operatively
Post-operative Pain Scores-FLACC
FLACC (Face, Legs, Activity, Cry, Consolability) scale
Measured: Up to 14 days post-operatively
Post-operative Sedation Scores-SBS
SBS (State Behavioral Scale)
Measured: Up to 14 days post-operatively
Length of Intubation
Measured: Up to 14 days post-operatively
Length of Non-Invasive Respiratory Support
Measured: Up to 14 days post-operatively
Average Post-operative Morphine Dose
Measured: Up to 14 days post-operatively
Average Post-operative Lorazepam Dose
Measured: Up to 14 days post-operatively
Average Post-operative Dexmedetomidine Dose
Measured: Up to 14 days post-operatively
Average Post-operative Total Fentanyl Dose
Measured: Up to 14 days post-operatively
Average Post-operative PCA Fentanyl Dose
Measured: Up to 14 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Mar 2017
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Why it stopped: Very small percentage of enrolled patients needing non-invasive support and small chance of us reaching target enrollment within funding period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gretchen A McGuire, RN, MSN, CPNP-AC, Principal investigator, Children's Hospitals and Clinics of MinnesotaRobert Horvath-Csongradi, MD, Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180385
- Sponsor's protocol ID
- 1701-008
- Acronym
- NAVA
- Status last verified
- Sep 2019
- First submitted
- 6 Jun 2017
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist (NAVA) Versus Conventional Biphasic Positive End Expiratory Pressure (BiPAP) Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
- ClinicalTrials.gov ID
- NCT03180385
- Acronym / sponsor ID
- NAVA / 1701-008
- Conditions
- Respiratory Failure
- Keywords
- NAVA, BiPAP, Pediatrics, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very small percentage of enrolled patients needing non-invasive support and small chance of us reaching target enrollment within funding period.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Posted 15 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to providing respiratory support post-operatively. The investigators hypothesize that providing synchronized biphasic support with NAVA will be associated with shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive either NAVA or BiPAP following their cardiothoracic surgery.
Detailed description
Mechanical ventilation is often very necessary in the care of critically ill pediatric patients. However, it comes with many different complications that include chronic lung disease, tissue damage, and ventilator-associated pneumonia. Over time, we have increased our understanding of how a child's physiology interacts with a ventilator and this has led to two different non-invasive forms of respiratory support: bilevel positive air pressure (BiPAP) and neurally adjusted ventilator assist (NAVA). While both modalities come with a lot of benefits such as improved gas exchange, decreased respiratory and heart rate and decreased inspiratory work of breathing, NAVA has the ability to provide synchronous ventilatory support due to the electrical activity of the diaphragm.
The purpose of this study is to compare clinical outcomes following use of NAVA versus BiPAP in patients undergoing cardiac surgery, Specifically, comparisons of non-invasive respiratory support, duration of sedation, and length of hospital stay. The investigators hypothesize that the use of NAVA will lead to a shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay compared to the use of BiPAP.
This is a single-site, prospective randomized study. Subjects are randomized into two arms: those who receive NAVA and those who receive BiPAP post-operatively.
Subjects will be followed for up to 14 days post-operatively or until they are discharged, whichever comes first. Pain medication administered, FLACC (Face, Legs, Activity, Cry, Consolability), and SBS (State Behavioral Scale) scores are recorded daily for up to 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurally-Adjusted Ventilatory Assist (NAVA) | Experimental | Device: Neurally-Adusted Ventilatory Assist (NAVA)Synchronized biphasic non-invasive respiratory support |
| Biphasic Positive Airway Pressure Support (BiPAP) | Active comparator | Device: Biphasic Positive Airway Pressure Support (BiPAP)Conventional non-invasive respiratory support |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Postoperative cardiac surgery patients admitted to the Cardiovascular Care Center (CVCC) at Children's Hospitals and Clinics of Minnesota
- Recommended for non-invasive (NIV) respiratory support following extubation, per provider discretion
- 0 to 12 months of age
Key exclusion criteria (13 listed)
- Documented airway malformation (congenital or acquired)
- Documented ENT abnormality
- Documented central apnea
- Patients who are overly sedated, per provider discretion
- Tracheostomy in place at time of cardiac surgery
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 |
|---|---|---|
| Neurally-Adusted Ventilatory Assist (NAVA)Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient. | Device | Neurally-Adjusted Ventilatory Assist (NAVA) |
| Biphasic Positive Airway Pressure Support (BiPAP)Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion. | Device | Biphasic Positive Airway Pressure Support (BiPAP) |
Primary outcome
Average Post-operative Midazolam Dose
Time frame: Up to 14 days post-operatively
Post-operative Pain Scores-FLACC
Time frame: Up to 14 days post-operatively
FLACC (Face, Legs, Activity, Cry, Consolability) scale
Post-operative Sedation Scores-SBS
Time frame: Up to 14 days post-operatively
SBS (State Behavioral Scale)
Length of Intubation
Time frame: Up to 14 days post-operatively
Length of Non-Invasive Respiratory Support
Time frame: Up to 14 days post-operatively
Average Post-operative Morphine Dose
Time frame: Up to 14 days post-operatively
Average Post-operative Lorazepam Dose
Time frame: Up to 14 days post-operatively
Average Post-operative Dexmedetomidine Dose
Time frame: Up to 14 days post-operatively
Average Post-operative Total Fentanyl Dose
Time frame: Up to 14 days post-operatively
Average Post-operative PCA Fentanyl Dose
Time frame: Up to 14 days post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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.
Gretchen A McGuire, RN, MSN, CPNP-AC principal investigator
Children's Hospitals and Clinics of Minnesota
Robert Horvath-Csongradi, MD principal investigator
Children's Hospitals and Clinics of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally-Adusted Ventilatory Assist (NAVA) and Biphasic Positive Airway Pressure Support (BiPAP) in people with Respiratory Failure, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 10 Mar 2020. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Post-operative Midazolam Dose (time frame: Up to 14 days post-operatively). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2020.