Qiao Lanxin, Wang Yaxin, Liang Yi, Xia Tian, Li Ling, Xiong Wei, Liu Bin, Feng Yifan, Liu Yan, Jin Xu, Zhang Jianmin
Department of Anesthesiology, Beijing Children's Hospital, Capital Medical University, Beijing, China.
Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Front Pediatr. 2023 Jun 19;11:1155666. doi: 10.3389/fped.2023.1155666. eCollection 2023.
Inadvertent perioperative hypothermia (IPH) refers to a core body temperature lower than 36.0 °C, which can contribute to many adverse events. The special physiological characteristics in children further increase the incidence of IPH. Therefore, it is very important to perform effective perioperative warming measures for children. Traditional passive warming measures with additional layers have limited thermal insulation effects. Active warming measures might be the better choice, and most measures have achieved good effects in adults. This study combines a variety of active warming measures to propose perioperative active warming strategies and aims to verify the feasibility and thermal insulation effects of perioperative active warming strategies in children.
This study is a multicentre, prospective, randomized controlled trial. From August 2022 to July 2024, 400 paediatric patients undergoing elective surgery will be recruited in four centres and randomly divided into the active warming strategies group and control group at a ratio of 1:1. The primary outcome is the perioperative cumulative hypothermia effect value (Ti × ti, i = 1…, ). Multiple complications covering the anaesthesia recovery period and postoperative hospitalization will be considered as secondary outcomes to comprehensively analyse the prognosis.
ClinicalTrials.gov identifier: ChiCTR2200062168. Registered on July 26th, 2022. Registered with the name of "Perioperative Active Warming Strategies in Children: A multicenter, prospective, randomized controlled trial". URL:http://www.chictr.org.cn/showproj.aspx?proj=172778.
围手术期意外低温（IPH）是指核心体温低于36.0°C，这可能导致许多不良事件。儿童特殊的生理特征进一步增加了IPH的发生率。因此，对儿童实施有效的围手术期保暖措施非常重要。传统的增加额外衣物的被动保暖措施隔热效果有限。主动保暖措施可能是更好的选择，并且大多数措施在成人中已取得良好效果。本研究结合多种主动保暖措施，提出围手术期主动保暖策略，旨在验证围手术期主动保暖策略在儿童中的可行性和隔热效果。
本研究是一项多中心、前瞻性、随机对照试验。从2022年8月至2024年7月，将在四个中心招募400例接受择期手术的儿科患者，并按1:1的比例随机分为主动保暖策略组和对照组。主要结局是围手术期累计低温效应值（Ti×ti，i = 1…）。将涵盖麻醉恢复期和术后住院期间的多种并发症作为次要结局，以综合分析预后。
ClinicalTrials.gov标识符：ChiCTR2200062168。于2022年7月26日注册。注册名称为“儿童围手术期主动保暖策略：一项多中心、前瞻性、随机对照试验”。网址：http://www.chictr.org.cn/showproj.aspx?proj=172778。
