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

Respiratory Failure Clinical Trial

— NAVA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03180385
• Other study ID #: 1701-008
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: April 10, 2018

Study information

• Verified date: September 2019
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• Biphasic Positive Airway Pressure Support (BiPAP)
Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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