Study protocol for the Anesthesiology Control Tower-Feedback Alerts to Supplement Treatments (ACTFAST-3) trial: a pilot randomized controlled trial in intraoperative telemedicine.
Study protocol for the Anesthesiology Control Tower-Feedback Alerts to Supplement Treatments (ACTFAST-3) trial: a pilot randomized controlled trial in intraoperative telemedicine.
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DOI：
10.12688/f1000research.14897.1
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发表时间：
2018-01-01
期刊：
影响因子：
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通讯作者：
Avidan, Michael S
中科院分区：
文献类型：
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作者：
Gregory, Stephen;Murray-Torres, Teresa M;Avidan, Michael S
背景：全世界每年有超过3亿人接受外科手术。尽管努力改善结果，术后发病率和死亡率是常见的。许多患者由于医疗错误或未能遵守既定的临床实践指南而出现并发症。本协议描述了一项临床试验，比较基于远程医疗的决策支持系统，麻醉控制塔（ACT）与增强的标准术中护理。方法：本研究是一项实用的、比较有效的试验，将大约12000名在手术室（OR）水平的成年外科患者随机分为对照组或干预组。作为增强标准术中护理的一部分，所有手术室临床医生都可以访问手术室内的决策支持软件。ACT将监测两组患者，并将为分配到干预手术室的临床医生提供额外支持。主要结局包括血糖控制和体温控制。次要结局包括替代结局、临床结局和经济结局，如术中低血压的发生率、术后呼吸损害、急性肾损伤、谵妄和挥发性麻醉剂的使用。伦理与传播：ACTFAST-3研究已获得圣路易斯华盛顿大学人力资源保护办公室（HRPO）的批准，并在clinicaltrials.gov上注册（NCT02830126）。该议定书的招募工作于2017年4月开始，将于2018年12月结束。本研究结果的传播将通过学术会议、期刊出版物和教育材料等形式进行。
Background: Each year, over 300 million people undergo surgical procedures worldwide. Despite efforts to improve outcomes, postoperative morbidity and mortality are common. Many patients experience complications as a result of either medical error or failure to adhere to established clinical practice guidelines. This protocol describes a clinical trial comparing a telemedicine-based decision support system, the Anesthesiology Control Tower (ACT), with enhanced standard intraoperative care. Methods: This study is a pragmatic, comparative effectiveness trial that will randomize approximately 12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group. All OR clinicians will have access to decision support software within the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in both groups and will provide additional support to the clinicians assigned to intervention ORs. Primary outcomes include blood glucose management and temperature management. Secondary outcomes will include surrogate, clinical, and economic outcomes, such as incidence of intraoperative hypotension, postoperative respiratory compromise, acute kidney injury, delirium, and volatile anesthetic utilization. Ethics and dissemination: The ACTFAST-3 study has been approved by the Human Resource Protection Office (HRPO) at Washington University in St. Louis and is registered at clinicaltrials.gov ( NCT02830126). Recruitment for this protocol began in April 2017 and will end in December 2018. Dissemination of the findings of this study will occur via presentations at academic conferences, journal publications, and educational materials.