Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial

神经调节通气辅助治疗急性呼吸衰竭:一项随机对照试验

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作者:Robert M Kacmarek, Jesús Villar, Dácil Parrilla, Francisco Alba, Rosario Solano, Songqiao Liu, Raquel Montiel, Jesús Rico-Feijoo, Anxela Vidal, Carlos Ferrando, Isabel Murcia, Ruth Corpas, Elena González-Higueras, Qin Sun, César E Pinedo, David Pestaña, Domingo Martínez, César Aldecoa, José M Añón, 

Conclusion

NAVA decreased duration of MV although it did not improve survival in ventilated patients with 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.

Purpose

We hypothesized that neurally adjusted ventilatory assist (NAVA) compared to conventional lung-protective mechanical ventilation (MV) decreases duration of MV and mortality in patients with acute respiratory failure (ARF).

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 difference - 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.

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