Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation

NCT ID: NCT02967549

Last Updated: 2021-09-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Bronchopulmonary Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NAVA then PAV

Infants randomised to NAVA then PAV

Group Type EXPERIMENTAL

NAVA

Intervention Type DEVICE

NAVA delivered by the Servo-n ventilator (Maquet)

PAV

Intervention Type DEVICE

PAV delivered by the Stephanie ventilator (Stephan)

PAV then NAVA

Infants randomised to PAV then NAVA

Group Type EXPERIMENTAL

NAVA

Intervention Type DEVICE

NAVA delivered by the Servo-n ventilator (Maquet)

PAV

Intervention Type DEVICE

PAV delivered by the Stephanie ventilator (Stephan)

Interventions

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NAVA

NAVA delivered by the Servo-n ventilator (Maquet)

Intervention Type DEVICE

PAV

PAV delivered by the Stephanie ventilator (Stephan)

Intervention Type DEVICE

Other Intervention Names

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neurally adjusted ventilatory assist Proportional Assist Ventilation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* major congenital abnormalities
Minimum Eligible Age

1 Week

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type BACKGROUND
PMID: 31980954 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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KCH16-150

Identifier Type: -

Identifier Source: org_study_id

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