Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial
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ORIGINAL
Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial Robert M. Kacmarek1,2*, Jesús Villar3,4* , Dácil Parrilla5, Francisco Alba6, Rosario Solano7, Songqiao Liu8, Raquel Montiel5, Jesús Rico‑Feijoo9, Anxela Vidal10, Carlos Ferrando3,11,17, Isabel Murcia12, Ruth Corpas6, Elena González‑Higueras7, Qin Sun8, César E. Pinedo5, David Pestaña13, Domingo Martínez14, César Aldecoa9, José M. Añón3,15, Marina Soro11, Jesús M. González‑Martín16, Cristina Fernández4 and Rosa L. Fernández3,4 on behalf of NAVa In Acute respiraTORy failure (NAVIATOR) Network © 2020 Springer-Verlag GmbH Germany, part of Springer Nature
Abstract Purpose: We hypothesized that neurally adjusted ventilatory assist (NAVA) compared to conventional lung-protec‑ tive mechanical ventilation (MV) decreases duration of MV and mortality in patients with acute respiratory failure (ARF). Methods: We carried out a multicenter, randomized, controlled trial in patients with ARF from several etiologies. Intubated patients ventilated for ≤ 5 days expected to require MV for ≥ 72 h and able to breathe spontaneously were eligible for enrollment. Eligible patients were randomly assigned based on balanced treatment assignments with a computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group). Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days (VFDs) at 28 days. Secondary outcome was all-cause hospital mortality. All analyses were done according to the intention-to-treat principle. Results: Between March 2014 and October 2019, we enrolled 306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group. Median VFDs were higher in the NAVA than in the control group (22 vs. 18 days; between-group difference 4 days; 95% confidence interval [CI] 0 to 8 days; p = 0.016). At hospital discharge, 39 (25.5%) patients in the NAVA group and 47 (30.7%) patients in the control group had died (between-group differ‑ ence − 5.2%, 95% CI − 15.2 to 4.8, p = 0.31). Other clinical, physiological or safety outcomes did not differ significantly between the trial groups. Conclusion: NAVA decreased duration of MV although it did not improve survival in ventilated patients with ARF. Keywords: Lung-protective ventilation, Acute respiratory failure, Neurally adjusted ventilatory assist, Intensive care unit, Ventilator-free days, Mortality
*Correspondence: [email protected]; [email protected] 1 Department of Respiratory Care, Massachusetts General Hospital, 55 Fruit St, Warren 1225, Boston, MA 01460, USA 3 CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain Full author information is available at the end of the article
Members of the “NAVa In Acute respiraTORy failure (NAVIATOR) Network” are listed in the Acknowledgement section.
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