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

Neurally Adjusted Ventilatory Assist (NAVA) Versus Conventional Biphasic Positive End Expiratory Pressure (BiPAP) Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03180385

Acronym

NAVA

Enrollment

Registered

2017-06-08

Start date

2017-03-01

Completion date

2018-04-10

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

NAVA, BiPAP, Pediatrics, Cardiac Surgery

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.

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.

Interventions

DEVICENeurally-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.

DEVICEBiphasic Positive Airway Pressure Support (BiPAP)

Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Average Post-operative Midazolam Dose	Up to 14 days post-operatively	—
Post-operative Pain Scores-FLACC	Up to 14 days post-operatively	FLACC (Face, Legs, Activity, Cry, Consolability) scale
Post-operative Sedation Scores-SBS	Up to 14 days post-operatively	SBS (State Behavioral Scale)
Length of Intubation	Up to 14 days post-operatively	—
Length of Non-Invasive Respiratory Support	Up to 14 days post-operatively	—
Average Post-operative Morphine Dose	Up to 14 days post-operatively	—
Average Post-operative Lorazepam Dose	Up to 14 days post-operatively	—
Average Post-operative Dexmedetomidine Dose	Up to 14 days post-operatively	—
Average Post-operative Total Fentanyl Dose	Up to 14 days post-operatively	—
Average Post-operative PCA Fentanyl Dose	Up to 14 days post-operatively	—

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
Neurally-Adjusted Ventilatory Assist (NAVA) 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.	0
Biphasic Positive Airway Pressure Support (BiPAP) 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.	2
Total	2

Baseline characteristics

Characteristic	Total	Biphasic Positive Airway Pressure Support (BiPAP)
Age, Continuous	0.46 years STANDARD_DEVIATION 0.04	0.46 years STANDARD_DEVIATION 0.04
Race and Ethnicity Not Collected	0 Participants	—
Region of Enrollment United States	2 participants	2 participants
Sex: Female, Male Female	1 Participants	1 Participants
Sex: Female, Male Male	1 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 2
other Total, other adverse events	0 / 0	0 / 2
serious Total, serious adverse events	0 / 0	1 / 2