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Clinical Trials/NCT02967549
NCT02967549
Completed
N/A

Optimisation of Neonatal Ventilation - NAVA vs PAV

King's College London1 site in 1 country18 target enrollmentNovember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bronchopulmonary Dysplasia
Sponsor
King's College London
Enrollment
18
Locations
1
Primary Endpoint
Oxygenation index
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
August 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • major congenital abnormalities

Outcomes

Primary Outcomes

Oxygenation index

Time Frame: 2 hours

Oxygenation index at the end of each period of ventilation

Study Sites (1)

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