Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation

Not Applicable

Completed

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Device: NAVA; Device: PAV

• Registration Number: NCT02967549
• Lead Sponsor: King's College London

Brief Summary

This study aims to assess whether neurally adjusted ventilatory assist or proportional assist ventilation is more effective in infants born prematurely with evolving or established bronchopulmonary dysplasia

Detailed Description

Despite improvements in survival rates of extremely preterm born infants, the incidence of bronchopulmonary dysplasia (BPD) remains unchanged over the last two decades. As invasive ventilation is frequently necessary and indeed life saving, numerous ventilator strategies have been developed to reduce damage to the developing lung. Synchronisation of mechanical breaths with the patient's respiratory effort offers the theoretical benefit of improving oxygenation and ventilation, requiring lower ventilator pressures, fewer air leaks and increased patient comfort.

Recently, novel modes of ventilation have been introduced that aim to improve upon conventional ventilation. During both proportional assist ventilation (PAV) and neurally-adjusted ventilatory assist (NAVA), respiratory support is servo-controlled based on continuous input from the baby's respiratory effort. Both aim to improve synchronization of the timing of the respiratory cycle and also to vary the level of support offered breath-to-breath in proportion to the respiratory effort of the patient.

During proportional assist ventilation (PAV), the ventilator can vary inflation pressure in phase with both volume change and flow change in order to offload both elastic and resistive components of the work of breathing. We have previously shown that PAV, compared to ACV, reduces the oxygenation index and improves respiratory muscle strength in infants born prematurely who remain ventilated at or beyond one week of life .

Neurally adjusted ventilatory assist (NAVA) utilises the electrical activity of the diaphragm to trigger the ventilator. A modified nasogastric feeding tube with a series of electrodes allows monitoring of the diaphragmatic electromyogram (Edi). The waveform of the Edi is used to trigger and control ventilator support. We have recently shown that NAVA compared to ACV results in a lower oxygenation index in infants born prematurely who remain ventilated at or beyond one week of life.

Both PAV and NAVA have been shown to have advantages above conventional triggered ventilation in neonates, but they have not been compared to each other. Our aim is to determine whether NAVA or PAV is more effective in prematurely born neonates with evolving or established BPD.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-18
• Status Verified: 2018-03
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Born at less than 32 weeks gestation
• ventilated at or beyond one week of life

Exclusion Criteria

• major congenital abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NAVA then PAV	NAVA	Infants randomised to NAVA then PAV
PAV then NAVA	NAVA	Infants randomised to PAV then NAVA
NAVA then PAV	PAV	Infants randomised to NAVA then PAV
PAV then NAVA	PAV	Infants randomised to PAV then NAVA

Primary Outcome Measures

Name	Time	Method
Oxygenation index	2 hours	Oxygenation index at the end of each period of ventilation

Trial Locations

Locations (1)

King's College Hospital; 🇬🇧 London, United Kingdom