Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation
NCT ID: NCT02967549
Last Updated: 2021-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2016-11-30
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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NAVA then PAV
Infants randomised to NAVA then PAV
NAVA
NAVA delivered by the Servo-n ventilator (Maquet)
PAV
PAV delivered by the Stephanie ventilator (Stephan)
PAV then NAVA
Infants randomised to PAV then NAVA
NAVA
NAVA delivered by the Servo-n ventilator (Maquet)
PAV
PAV delivered by the Stephanie ventilator (Stephan)
Interventions
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NAVA
NAVA delivered by the Servo-n ventilator (Maquet)
PAV
PAV delivered by the Stephanie ventilator (Stephan)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ventilated at or beyond one week of life
Exclusion Criteria
1 Week
1 Year
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Anne Greenough, MD, FRCPCH
Role: STUDY_DIRECTOR
King's College London
Locations
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King's College Hospital
London, , United Kingdom
Countries
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References
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Hunt KA, Dassios T, Greenough A. Proportional assist ventilation (PAV) versus neurally adjusted ventilator assist (NAVA): effect on oxygenation in infants with evolving or established bronchopulmonary dysplasia. Eur J Pediatr. 2020 Jun;179(6):901-908. doi: 10.1007/s00431-020-03584-w. Epub 2020 Jan 25.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KCH16-150
Identifier Type: -
Identifier Source: org_study_id
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