Neurally Adjusted Ventilatory Assist (NAVA) Versus Conventional Biphasic Positive End Expiratory Pressure (BiPAP) Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Length of Intubation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 12 Months (Child)
- Sex
- 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)
- •Laryngomalacia
- •Bronchomalacia
- •Laryngeal web
- •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
Arms & Interventions
Neurally-Adjusted Ventilatory Assist (NAVA)
Synchronized biphasic non-invasive respiratory support
Intervention: Neurally-Adusted Ventilatory Assist (NAVA) (Device)
Biphasic Positive Airway Pressure Support (BiPAP)
Conventional non-invasive respiratory support
Intervention: Biphasic Positive Airway Pressure Support (BiPAP) (Device)
Outcomes
Primary Outcomes
Length of Intubation
Time Frame: Up to 14 days post-operatively
Average Post-operative Morphine Dose
Time Frame: Up to 14 days post-operatively
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
Average Post-operative Lorazepam Dose
Time Frame: Up to 14 days post-operatively
Average Post-operative PCA Fentanyl Dose
Time Frame: Up to 14 days post-operatively
Post-operative Sedation Scores-SBS
Time Frame: Up to 14 days post-operatively
SBS (State Behavioral Scale)
Average Post-operative Total Fentanyl Dose
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 Dexmedetomidine Dose
Time Frame: Up to 14 days post-operatively
Secondary Outcomes
No secondary outcomes reported