CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Noninvasive neurally adjusted ventilatory assist (NIV NAVA) +1 moreother
Likely dose
Not stated in record
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Search/NCT02788110
NCT02788110N/ACompleted

Prospective Crossover Comparison of Work of Breathing During Non-invasive Ventilation: Neurally Adjusted Ventilatory Assist (NAVA) Versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Premature Neonates

Arkansas Children's Hospital Research Institute·interventional·Posted Jun 2, 2016·Updated Jan 11, 2019

In Brief

A clinical study evaluating Noninvasive neurally adjusted ventilatory assist (NIV NAVA) and Nasal intermittent positive pressure ventilation (NIPPV) for Respiratory Distress Syndrome, Newborn and Bronchopulmonary Dysplasia. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Background: Non-invasive forms of respiratory support have been developed to manage respiratory distress and failure in premature newborns without exposing them to the risks associated with invasive mechanical ventilation. It has been difficult to synchronize non-invasive ventilation due to the large air leaks, high respiratory rates, and small tidal volumes inherent to this interface and population. Neurally adjusted ventilatory assist (NAVA) is a novel mode of ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize ventilator support to the patient's own respiratory efforts and to support these efforts as needed. Few studies have examined the use of NAVA with non-invasive ventilation (NIV) in preterm neonates. A group at Arkansas Children's Hospital recently completed a study, looking at work of breathing in an animal model comparing NIV NAVA with the unsynchronized nasal intermittent positive pressure (NIPPV) mode currently used at this hospital. They were able to show that work of breathing was lower with NAVA in this model. This study will take what was shown in the animal model and translate this to the bedside. Using respiratory inductance plethysmography to measure thoracoabdominal asynchrony, this study will compare work of breathing during NIPPV versus NIV NAVA in preterm neonates with respiratory insufficiency. Hypothesis: Work of breathing as estimated by the phase angle (θ) using respiratory inductance plethysmography will be decreased with the use of NIV NAVA in comparison to unsynchronized NIPPV in premature neonates with respiratory insufficiency. Methods: Fifteen premature neonates of between 1-2 kilograms' current weight, with gestational age at birth between 24-34 weeks, and receiving non-invasive ventilation will be enrolled in the study after consent is obtained. The infants will be ventilated using NIV NAVA and NIPPV applied in random order for 15 minutes each while using respiratory inductance plethysmography to measure thoracoabdominal asynchrony as an estimate of work of breathing. Significance: This study will identify whether or not NIV NAVA has advantages over NIPPV for improving work of breathing in premature neonates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2, 2016
Enrollment StartAug 1, 2016
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.1 years ago

Interventions

Noninvasive neurally adjusted ventilatory assist (NIV NAVA)other

Neurally adjusted ventilatory assist (NAVA) is a mode of ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize ventilator support to the patient's own respiratory efforts and to support these efforts as needed.

Nasal intermittent positive pressure ventilation (NIPPV)other

Nasal intermittent positive pressure ventilation (NIPPV) or noninvasive pressure control ventilation (NIV PC) is a mode of ventilation delivering unsynchronized puffs of air or "breaths" to a baby through nasal cannulae.