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

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, 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

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.

Keywords: Critical care; Interactive ventilatory support; NAVA studies; Randomized controlled trial; Weaning.

Conflict of interest statement

D.J.H. has received funds from Maquet/Getinge to cover the travel, accommodation, and registration for conferences and meetings prior to 2016. All other authors have no conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1
Flow diagram of the clinical trial. NAVA = neurally adjusted 155 ventilatory assist; PSV = pressure support ventilation; NGT = naso-gastric tube; MV = mechanical ventilation; TBI = traumatic brain injury
Fig. 2
Fig. 2
Kaplan-Meier estimates of probability of unassisted breathing and live discharge from ICU from randomization to D28. In keeping with previous trials [21, 22], unassisted breathing is defined as (1) extubated with supplemental oxygen or room air, or (2) open T-tube breathing, or (3) tracheostomy mask breathing, or (4) continuous positive airway pressure (CPAP) ≤ 5 cm H20 without pressure support and with no return to assisted breathing or death within 48 h. Participants receiving pressure support via non-invasive ventilation or CPAP > 5 cm H2O via any medium were defined as receiving assisted ventilation. NAVA = neurally adjusted ventilatory assist; PSV = pressure support ventilation

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