Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation

September 15, 2021 updated by: King's College London

Optimisation of Neonatal Ventilation - NAVA vs PAV

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • major congenital abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAVA then PAV
Infants randomised to NAVA then PAV
Device: NAVA
NAVA delivered by the Servo-n ventilator (Maquet)
Other Names:
  • neurally adjusted ventilatory assist
Device: PAV
PAV delivered by the Stephanie ventilator (Stephan)
Other Names:
  • Proportional Assist Ventilation
Experimental: PAV then NAVA
Infants randomised to PAV then NAVA
Device: NAVA
NAVA delivered by the Servo-n ventilator (Maquet)
Other Names:
  • neurally adjusted ventilatory assist
Device: PAV
PAV delivered by the Stephanie ventilator (Stephan)
Other Names:
  • Proportional Assist Ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation index
Time Frame: 2 hours
Oxygenation index at the end of each period of ventilation
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCH16-150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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