Clinical trial NCT03180385: NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Failure
Keywords: NAVA
BiPAP
Pediatrics
Cardiac Surgery
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 15
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Post-operative Midazolam Dose
timeFrame: Up to 14 days post-operatively
measure: Post-operative Pain Scores-FLACC
timeFrame: Up to 14 days post-operatively
measure: Post-operative Sedation Scores-SBS
timeFrame: Up to 14 days post-operatively
measure: Length of Intubation
timeFrame: Up to 14 days post-operatively
measure: Length of Non-Invasive Respiratory Support
timeFrame: Up to 14 days post-operatively
measure: Average Post-operative Morphine Dose
timeFrame: Up to 14 days post-operatively
measure: Average Post-operative Lorazepam Dose
timeFrame: Up to 14 days post-operatively
measure: Average Post-operative Dexmedetomidine Dose
timeFrame: Up to 14 days post-operatively
measure: Average Post-operative Total Fentanyl Dose
timeFrame: Up to 14 days post-operatively
measure: Average Post-operative PCA Fentanyl Dose
timeFrame: Up to 14 days post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Gretchen A McGuire, RN, MSN, CPNP-AC
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospitals and Clinics of Minnesota
name: Robert Horvath-Csongradi, MD
role: PRINCIPAL_INVESTIGATOR
References: