PDF(Pubmed)
Abstract：
BACKGROUND: One single-center randomized clinical trial showed that INTELLiVENT-adaptive support ventilation (ASV) is superior to conventional ventilation with respect to the quality of ventilation in post-cardiac surgery patients. Other studies showed that this automated ventilation mode reduces the number of manual interventions at the ventilator in various types of critically ill patients. In this multicenter study in patients post-cardiac surgery, we test the hypothesis that INTELLiVENT-ASV is superior to conventional ventilation with respect to the quality of ventilation.
METHODS: \"POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II)\" is an international, multicenter, two-group randomized clinical superiority trial. In total, 328 cardiac surgery patients will be randomized. Investigators screen patients aged > 18 years of age, scheduled for elective cardiac surgery, and expected to receive postoperative ventilation in the ICU for longer than 2 h. 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 quality of ventilation, defined as the proportion of postoperative ventilation time characterized by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first two postoperative hours. One major secondary endpoint is ICU team staff workload, captured by the ventilator software collecting manual settings on alarms. Patient-centered endpoints include duration of postoperative ventilation and length of stay in ICU.
CONCLUSIONS: POSITiVE II is the first international, multicenter, randomized clinical trial designed to confirm that POStoperative INTELLiVENT-ASV is superior to non-automated conventional ventilation and secondary to determine if this closed-loop ventilation mode reduces ICU team staff workload. The results of POSITiVE II will support intensive care teams in their choices regarding the use of automated ventilation in postoperative care of uncomplicated cardiac surgery patients.
BACKGROUND: Clinicaltrials.gov NCT06178510 . Registered on December 4, 2023.
METHODS: \"POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II)\" is an international, multicenter, two-group randomized clinical superiority trial. In total, 328 cardiac surgery patients will be randomized. Investigators screen patients aged > 18 years of age, scheduled for elective cardiac surgery, and expected to receive postoperative ventilation in the ICU for longer than 2 h. 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 quality of ventilation, defined as the proportion of postoperative ventilation time characterized by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first two postoperative hours. One major secondary endpoint is ICU team staff workload, captured by the ventilator software collecting manual settings on alarms. Patient-centered endpoints include duration of postoperative ventilation and length of stay in ICU.
CONCLUSIONS: POSITiVE II is the first international, multicenter, randomized clinical trial designed to confirm that POStoperative INTELLiVENT-ASV is superior to non-automated conventional ventilation and secondary to determine if this closed-loop ventilation mode reduces ICU team staff workload. The results of POSITiVE II will support intensive care teams in their choices regarding the use of automated ventilation in postoperative care of uncomplicated cardiac surgery patients.
BACKGROUND: Clinicaltrials.gov NCT06178510 . Registered on December 4, 2023.
摘要：
背景：一项单中心随机临床试验表明，在心脏手术后患者的通气质量方面，INTELLiVENT适应性支持通气（ASV）优于常规通气。其他研究表明，这种自动通气模式减少了各种类型的危重病人的呼吸机人工干预次数。在这项针对心脏手术后患者的多中心研究中，我们检验了以下假设：在通风质量方面，INTELLiVENT-ASV优于常规通风。
方法：\“心脏手术患者II（POSITIVEII）的自适应INTELLiVENT后支持VEntlation”是一种国际性，多中心，两组随机临床优势试验。总的来说,328名心脏手术患者将被随机分配。调查人员对年龄>18岁的患者进行筛查，计划进行心脏择期手术,并且预计在ICU接受术后通气时间超过2小时。患者要么通过INTELLiVENT-ASV接受自动通气，要么通过常规通气模式不自动通气。主要终点是通气质量，定义为以暴露于预定义的最佳状态为特征的术后通气时间的比例，可接受,以及术后前两个小时的关键（有害）通气参数。一个主要的次要终点是ICU团队员工工作量，由呼吸机软件收集警报的手动设置捕获。以患者为中心的终点包括术后通气时间和ICU住院时间。
结论：POSITIVEII是第一个国际，多中心，随机临床试验旨在确认POStoperativeINTELLiVENT-ASV优于非自动常规通气,并且是确定这种闭环通气模式是否减少ICU团队工作人员工作量的次要试验.POSITIVEII的结果将支持重症监护团队选择在简单的心脏手术患者的术后护理中使用自动通气。
背景：Clinicaltrials.govNCT06178510。2023年12月4日注册。
方法：\“心脏手术患者II（POSITIVEII）的自适应INTELLiVENT后支持VEntlation”是一种国际性，多中心，两组随机临床优势试验。总的来说,328名心脏手术患者将被随机分配。调查人员对年龄>18岁的患者进行筛查，计划进行心脏择期手术,并且预计在ICU接受术后通气时间超过2小时。患者要么通过INTELLiVENT-ASV接受自动通气，要么通过常规通气模式不自动通气。主要终点是通气质量，定义为以暴露于预定义的最佳状态为特征的术后通气时间的比例，可接受,以及术后前两个小时的关键（有害）通气参数。一个主要的次要终点是ICU团队员工工作量，由呼吸机软件收集警报的手动设置捕获。以患者为中心的终点包括术后通气时间和ICU住院时间。
结论：POSITIVEII是第一个国际，多中心，随机临床试验旨在确认POStoperativeINTELLiVENT-ASV优于非自动常规通气,并且是确定这种闭环通气模式是否减少ICU团队工作人员工作量的次要试验.POSITIVEII的结果将支持重症监护团队选择在简单的心脏手术患者的术后护理中使用自动通气。
背景：Clinicaltrials.govNCT06178510。2023年12月4日注册。
