NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/20/2019 |
| Start Date: | March 1, 2017 |
| End Date: | April 10, 2018 |
Neurally Adjusted Ventilatory Assist (NAVA) Versus Conventional Biphasic Positive End Expiratory Pressure (BiPAP) Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery
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.
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.
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.
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.
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
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