NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery

• Sponsor: Children's Hospitals and Clinics of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03180385
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.3
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Device: Neurally-Adusted Ventilatory Assist (NAVA); Device: Biphasic Positive Airway Pressure Support (BiPAP)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: Apr 10, 2018
• Actual Study Completion Date: Apr 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurally-Adjusted Ventilatory Assist (NAVA) Synchronized biphasic non-invasive respiratory support	Device: 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.
Active Comparator: Biphasic Positive Airway Pressure Support (BiPAP) Conventional non-invasive respiratory support	Device: Biphasic Positive Airway Pressure Support (BiPAP); Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.

Outcome Measures

Primary Outcome Measures

1. Average Post-operative Midazolam Dose [Up to 14 days post-operatively]

2. Post-operative Pain Scores-FLACC [Up to 14 days post-operatively]

   FLACC (Face, Legs, Activity, Cry, Consolability) scale

3. Post-operative Sedation Scores-SBS [Up to 14 days post-operatively]

   SBS (State Behavioral Scale)

4. Length of Intubation [Up to 14 days post-operatively]

5. Length of Non-Invasive Respiratory Support [Up to 14 days post-operatively]

6. Average Post-operative Morphine Dose [Up to 14 days post-operatively]

7. Average Post-operative Lorazepam Dose [Up to 14 days post-operatively]

8. Average Post-operative Dexmedetomidine Dose [Up to 14 days post-operatively]

9. Average Post-operative Total Fentanyl Dose [Up to 14 days post-operatively]

10. Average Post-operative PCA Fentanyl Dose [Up to 14 days post-operatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Documented airway malformation (congenital or acquired)

1. Laryngomalacia

2. Bronchomalacia

3. Laryngeal web

4. Tracheal or bronchial rings (complete or incomplete)

• Documented ENT abnormality

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota	United States	55404

Sponsors and Collaborators

• Children's Hospitals and Clinics of Minnesota

Investigators

• Principal Investigator: Gretchen A McGuire, RN, MSN, CPNP-AC, Children's Hospitals and Clinics of Minnesota
• Principal Investigator: Robert Horvath-Csongradi, MD, Children's Hospitals and Clinics of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 10, 2018

More Information

Publications

None provided.

• Responsible Party: Children's Hospitals and Clinics of Minnesota
• ClinicalTrials.gov Identifier: NCT03180385
• Other Study ID Numbers: 1701-008
• First Posted: Jun 8, 2017
• Last Update Posted: Mar 10, 2020
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Children's Hospitals and Clinics of Minnesota: NAVA; BiPAP; Pediatrics; Cardiac Surgery
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

Participant Flow

Pre-assignment Detail	Informed consent was obtained for 15 participants. However, the reason there are only 2 participants listed under "total started in participant flow" is because these were the only participants who were actually randomized. The other 13 participants were extubated and did not need BiPAP/NAVA. They were not randomized and were excluded.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Period Title: Overall Study
STARTED	0	2
COMPLETED	0	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)	Total
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.	Total of all reporting groups
Overall Participants	0	2	2
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	0.46 (0.04)	0.46 (0.04)
Sex: Female, Male (Count of Participants)
Female	1 Infinity	1 50%
Male	1 Infinity	1 50%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 NaN
Region of Enrollment (participants) [Number]
United States	2 Infinity	2 100%

Outcome Measures

1. Primary Outcome

Title	Average Post-operative Midazolam Dose
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

All patients who were randomized ended up in the BiPAP group and not the NAVA group.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	2
Mean (Standard Deviation) [mg/kg]	0.035 (0.007)

2. Primary Outcome

Title	Post-operative Pain Scores-FLACC
Description	FLACC (Face, Legs, Activity, Cry, Consolability) scale
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

There were no FLACC scores in the electronic medical record for either of these 2 participants so this is why there are no results reported.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	0

3. Primary Outcome

Title	Post-operative Sedation Scores-SBS
Description	SBS (State Behavioral Scale)
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

There were no SBS scores in the electronic medical record for either of these 2 participants so this is why results were not reported.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	0

4. Primary Outcome

Title	Length of Intubation
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

All patients who were randomized ended up in the BiPAP group and not the NAVA group.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	2
Mean (Standard Deviation) [hours]	37.24 (3.87)

5. Primary Outcome

Title	Length of Non-Invasive Respiratory Support
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

For this outcome, data for only one participant is available

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	1
Number [hours]	7.17

6. Primary Outcome

Title	Average Post-operative Morphine Dose
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

All patients who were randomized ended up in the BiPAP group and not the NAVA group.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	2
Mean (Standard Deviation) [mg/kg]	NA (NA)

7. Primary Outcome

Title	Average Post-operative Lorazepam Dose
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

All patients who were randomized ended up in the BiPAP group and not the NAVA group.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	2
Mean (Standard Deviation) [mg/kg]	0.11 (0.15)

8. Primary Outcome

Title	Average Post-operative Dexmedetomidine Dose
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

All patients who were randomized ended up in the BiPAP group and not the NAVA group.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	2
Mean (Standard Deviation) [mcg/kg]	6.71 (9.49)

9. Primary Outcome

Title	Average Post-operative Total Fentanyl Dose
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

All patients who were randomized ended up in the BiPAP group and not the NAVA group.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	2
Mean (Standard Deviation) [mcg/kg]	8.09 (7.06)

10. Primary Outcome

Title	Average Post-operative PCA Fentanyl Dose
Time Frame	Up to 14 days post-operatively

Outcome Measure Data

Analysis Population Description

All patients who were randomized ended up in the BiPAP group and not the NAVA group.

Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)	Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.	Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
Measure Participants	0	2
Mean (Standard Deviation) [boluses]	NA (NA)

Adverse Events

Time Frame	Adverse event data was collected over the span of the patient's hospital stay, specifically up to 14 days post-cardiac surgery.
Adverse Event Reporting Description	Adverse events were assessed via review of daily progress notes by both cardiology and cardiac intensive care providers within the electronic medical record (EMR).
Arm/Group Title	Neurally-Adjusted Ventilatory Assist (NAVA)		Biphasic Positive Airway Pressure Support (BiPAP)
Arm/Group Description	Synchronized biphasic non-invasive respiratory support 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.		Conventional non-invasive respiratory support Biphasic Positive Airway Pressure Support (BiPAP): Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
All Cause Mortality
	Neurally-Adjusted Ventilatory Assist (NAVA)		Biphasic Positive Airway Pressure Support (BiPAP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/2 (0%)
Serious Adverse Events
	Neurally-Adjusted Ventilatory Assist (NAVA)		Biphasic Positive Airway Pressure Support (BiPAP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/2 (50%)
Respiratory, thoracic and mediastinal disorders
Re-intubation	0/0 (NaN)	0	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	Neurally-Adjusted Ventilatory Assist (NAVA)		Biphasic Positive Airway Pressure Support (BiPAP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.