Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
Department of Intensive Care, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.
Trials. 2022 Apr 23;23(1):348. doi: 10.1186/s13063-022-06286-w.
INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of ventilation for use in critically ill patients. Evidence for benefit of INTELLiVENT-ASV in comparison to ventilation that is not fully automated with regard to duration of ventilation and quality of breathing is largely lacking. We test the hypothesis that INTELLiVENT-ASV shortens time spent on a ventilator and improves the quality of breathing.
The "Effects of Automated Closed-loop VenTilation versus Conventional Ventilation on Duration and Quality of Ventilation" (ACTiVE) study is an international, multicenter, two-group randomized clinical superiority trial. In total, 1200 intensive care unit (ICU) patients with an anticipated duration of ventilation of > 24 h will be randomly assigned to one of the two ventilation strategies. Investigators screen patients aged 18 years or older at start of invasive ventilation in the ICU. Patients either receive automated ventilation by means of INTELLiVENT-ASV, or ventilation that is not automated by means of a conventional ventilation mode. The primary endpoint is the number of days free from ventilation and alive at day 28; secondary endpoints are quality of breathing using granular breath-by-breath analysis of ventilation parameters and variables in a time frame of 24 h early after the start of invasive ventilation, duration of ventilation in survivors, ICU and hospital length of stay (LOS), and mortality rates in the ICU and hospital, and at 28 and 90 days.
ACTiVE is one of the first randomized clinical trials that is adequately powered to compare the effects of automated closed-loop ventilation versus conventional ventilation on duration of ventilation and quality of breathing in invasively ventilated critically ill patients. The results of ACTiVE will support intensivist in their choices regarding the use of automated ventilation.
ACTiVE is registered in clinicaltrials.gov (study identifier: NCT04593810 ) on 20 October 2020.
INTELLiVENT-自适应支持通气（ASV）是一种用于重症患者的完全自动化闭环通气模式。关于 INTELLiVENT-ASV 与不完全自动化通气相比在通气持续时间和呼吸质量方面的益处的证据在很大程度上仍然缺乏。我们检验了 INTELLiVENT-ASV 可缩短机械通气时间并改善呼吸质量的假设。
“自动化闭环通气与常规通气对通气时间和质量的影响”（ACTiVE）研究是一项国际性、多中心、两组随机临床优效性试验。总共将有 1200 名预计通气时间超过 24 小时的重症监护病房（ICU）患者被随机分配到两种通气策略之一。研究者筛选 ICU 开始有创通气时年龄在 18 岁或以上的患者。患者要么接受 INTELLiVENT-ASV 的自动通气，要么接受常规通气模式的非自动通气。主要终点是第 28 天无通气且存活的天数；次要终点是使用通气参数的逐次呼吸粒度分析和早期开始有创通气 24 小时内的通气变量来评估呼吸质量，以及幸存者的通气持续时间、ICU 和住院时长（LOS）以及 ICU 和医院的死亡率，以及 28 天和 90 天的死亡率。
ACTiVE 是第一项在比较自动闭环通气与常规通气对接受有创通气的重症患者通气持续时间和呼吸质量影响方面具有足够效能的随机临床试验之一。ACTiVE 的结果将支持重症监护医生在使用自动通气方面做出选择。
ACTiVE 于 2020 年 10 月 20 日在 clinicaltrials.gov 上注册（研究标识符：NCT04593810）。
