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Critical Care
Published in: Critical Care 1/2020

Open Access 01-12-2020 | Research

Neurally adjusted ventilatory assist versus pressure support ventilation: a randomized controlled feasibility trial performed in patients at risk of prolonged mechanical ventilation

Authors: Daniel J. Hadfield, Louise Rose, Fiona Reid, Victoria Cornelius, Nicholas Hart, Clare Finney, Bethany Penhaligon, Jasmine Molai, Clair Harris, Sian Saha, Harriet Noble, Emma Clarey, Leah Thompson, John Smith, Lucy Johnson, Phillip A. Hopkins, Gerrard F. Rafferty

Published in: Critical Care | Issue 1/2020

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Abstract

Background

The clinical effectiveness of neurally adjusted ventilatory assist (NAVA) has yet to be demonstrated, and preliminary studies are required. The study aim was to assess the feasibility of a randomized controlled trial (RCT) of NAVA versus pressure support ventilation (PSV) in critically ill adults at risk of prolonged mechanical ventilation (MV).

Methods

An open-label, parallel, feasibility RCT (n = 78) in four ICUs of one university-affiliated hospital. The primary outcome was mode adherence (percentage of time adherent to assigned mode), and protocol compliance (binary—≥ 65% mode adherence). Secondary exploratory outcomes included ventilator-free days (VFDs), sedation, and mortality.

Results

In the 72 participants who commenced weaning, median (95% CI) mode adherence was 83.1% (64.0–97.1%) and 100% (100–100%), and protocol compliance was 66.7% (50.3–80.0%) and 100% (89.0–100.0%) in the NAVA and PSV groups respectively. Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0–11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2–0.9; p = 0.032) for NAVA. Although overall sedation was similar, Richmond Agitation and Sedation Scale (RASS) scores were closer to zero in NAVA compared to PSV (p = 0.020). No significant differences were observed in duration of MV, ICU or hospital stay, or ICU, D28, and D90 mortality.

Conclusions

This feasibility trial demonstrated good adherence to assigned ventilation mode and the ability to meet a priori protocol compliance criteria. Exploratory outcomes suggest some clinical benefit for NAVA compared to PSV. Clinical effectiveness trials of NAVA are potentially feasible and warranted.

Trial registration

ClinicalTrials.​gov, NCT01826890. Registered 9 April 2013.
Appendix
Available only for authorised users
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Metadata
Title
Neurally adjusted ventilatory assist versus pressure support ventilation: a randomized controlled feasibility trial performed in patients at risk of prolonged mechanical ventilation
Authors
Daniel J. Hadfield
Louise Rose
Fiona Reid
Victoria Cornelius
Nicholas Hart
Clare Finney
Bethany Penhaligon
Jasmine Molai
Clair Harris
Sian Saha
Harriet Noble
Emma Clarey
Leah Thompson
John Smith
Lucy Johnson
Phillip A. Hopkins
Gerrard F. Rafferty
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2020
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-020-02923-5

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