Fan Cheng-Yi, Huang Sih-Shiang, Chen Chi-Hsin, Sung Chih-Wei, Chang Chin-Hao, Hung Tung-Hsiu, Liu Yen-Chen, Huang Edward Pei-Chuan
Department of Emergency Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan.
Graduate Institute of Biomedical Informatics, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan.
Resusc Plus. 2024 Nov 16;20:100827. doi: 10.1016/j.resplu.2024.100827. eCollection 2024 Dec.
The PIVOT trial evaluates the clinical outcomes and ventilatory quality of an automatic pneumatic ventilation method compared to a bag-valve-mask ventilation method in patients who have experienced out-of-hospital cardiac arrest and have had an advanced airway placed.
The PIVOT trial is a pragmatic, open-label, multicenter randomized controlled trial. It aims to recruit 514 patients in Hsinchu County, Taiwan. Adult, non-trauma patients who experience out-of-hospital cardiac arrest, are treated by emergency medical services, and have an advanced airway in place will be randomized. Biweekly cluster randomization will assign EMS teams to either the automatic pneumatic ventilation group or the bag-valve-mask group. Informed consent is waived. The primary outcome is the return of spontaneous circulation, either prehospital or in-hospital. Secondary outcomes include survival to discharge, neurological outcomes, prehospital ventilatory quality, and the content of prehospital resuscitation. Participants will be followed until they pass away or are discharged from the hospital.
The PIVOT trial will provide new insight on the clinical effectiveness of automatic pneumatic ventilation in patients experienced out-of-hospital cardiac arrest.: NCT06067204 in .
PIVOT试验评估在院外心脏骤停且已放置高级气道的患者中,自动气动通气方法与袋阀面罩通气方法相比的临床结局和通气质量。
PIVOT试验是一项实用的、开放标签的多中心随机对照试验。其目标是在台湾新竹县招募514名患者。经历院外心脏骤停、接受紧急医疗服务且已放置高级气道的成年非创伤患者将被随机分组。每两周进行一次整群随机化,将急救医疗团队分配到自动气动通气组或袋阀面罩组。无需知情同意。主要结局是院前或院内自主循环恢复。次要结局包括出院存活、神经学结局、院前通气质量以及院前复苏内容。参与者将被随访直至死亡或出院。
PIVOT试验将为自动气动通气在院外心脏骤停患者中的临床有效性提供新的见解。:临床试验编号NCT06067204 。