美国克利夫兰诊所Daniel I Sessler团队比较了非心脏手术期间积极术中升温与常规热管理对患者心血管预后的影响。2022年4月5日出版的《柳叶刀》杂志发表了这项成果。

术中中度低温会导致心肌损伤、手术部位感染和失血。积极升温至接近37°C的正常体温是否会改善预后仍不清楚。该研究旨在检验术中积极升温减少重大围手术期并发症的假设。

在这项多中心、平行组、优势试验中，研究组在中国12个机构和美国克利夫兰诊所招募患者，将其按1:1随机分配，在非心脏手术期间分别接受积极升温至目标核心温度37°C（积极升温组）或常规热管理至目标温度35.5°C（常规热管理组）。

符合条件的患者（年龄≥45岁）至少有一个心血管危险因素，计划住院接受非心脏手术，预计在全身麻醉下持续2-6小时，且预计至少有一半的前皮肤表面可用于升温。排除需要透析的患者和体重指数超过30 kg/m²的患者。主要结局是心肌损伤（肌钙蛋白升高，明显缺血性起源）、非致命性心脏骤停和手术后30天内全因死亡率的综合结局，均在改良意向治疗人群中评估。

2017年3月27日至2021年3月16日，共招募了5056名参加者，其中5013名被纳入意向治疗人群，积极升温组2507名，常规热管理组2506名。积极升温组患者术中核心温度的平均值为37.1℃，而常规热管理组为35.6℃。积极升温组2497名患者中有246名（9.9%）至少出现三种主要结局（非心脏手术后心肌损伤、心脏骤停或死亡）之一，常规热管理组2490名患者中有239名（9.6%）。

积极升温组与常规热管理组的共同效应相对风险估计为1.04，组间差异不显著。积极升温组中有39例患者发生不良事件（其中17例严重），常规热管理组中有54例（其中30例严重）。积极升温组中发生1例极其严重的不良事件，被认为可能与温度管理有关。

研究结果表明，在随机接受35.5°C和37°C的患者中，30天重大心血管结局的发生率没有显著差异。至少在1.5°C的范围内，从非常轻微的低温到完全正常体温，没有证据表明任何实质性结局发生变化。在外科患者中，保持核心温度至少35.5°C似乎已足够。

附：英文原文

Title: Aggressive intraoperative warming versus routine thermal management during non-cardiac surgery (PROTECT): a multicentre, parallel group, superiority trial

Author: Daniel I Sessler, Lijian Pei, Kai Li, Shusen Cui, Matthew T V Chan, Yuguang Huang, Jingxiang Wu, Xuemei He, Gausan R Bajracharya, Eva Rivas, Carmen K M Lam, Kai Li, Shusen Cui, Yaozhong Zhang, Hai Sun, Zhouting Hu, Wangyu Li, Yangdong Han, Wei Han, Pengcheng Zhao, Hong Ye, Peng Chen, Zhihua Zhu, Weisong Dai, Lei Jin, Wenchao Bian, Yan Liu, Matthew T V Chan, Beaker B Y Fung, Eva Lee, Ka Yan Hui, Gordon Y S Choi, Wai Tat Wong, Chee Sam Chan, Lijian Pei, Yuguang Huang, Yi Xiao, Bin Wu, Weiming Kang, Ling Lan, Chen Sun, Jingxiang Wu, Yuwei Qiu, Wei Tang, Yunyun Zhang, Qi Huang, Xiaofei Lu, Tingting Li, Qimeng Yu, Jie Yu, Xuemei He, Rurong Wang, Hong Chang, Yunxia Zuo, Zhirong Sun, Wenting Hou, Congxia Pan, Xi Liu, Xue Zhang, Sheng Wang, Yin Kang, Zhengliang Ma, Xiaoping Gu, Changhong Miao, Daniel I Sessler, Eva Rivas, Gausan R Bajracharya, Mauro Bravo, Andrea Kurz, Alparslan Turan, Kurt Ruetzler, Kamal Maheshwari, Guangmei Mao, Yanyan Han, Ece Yamak Altinpulluk, Mateo Montalvo Compana, Federico Almonacid-Cardenas, Steve M Leung, CeCelia K Hanline, David M Chelnick, Marianne Tanios, Michael Walters, Michael J Rosen, Stephanie Ezoke, Edward J Mascha, Carmen K M Lam, Benny C P Cheng, Renee P L Yip, P J Devereaux

Issue&Volume: 2022-04-05

Abstract:

Background

Moderate intraoperative hypothermia promotes myocardial injury, surgical site infections, and blood loss. Whether aggressive warming to a truly normothermic temperature near 37°C improves outcomes remains unknown. We aimed to test the hypothesis that aggressive intraoperative warming reduces major perioperative complications.

Methods

In this multicentre, parallel group, superiority trial, patients at 12 sites in China and at the Cleveland Clinic in the USA were randomly assigned (1:1) to receive either aggressive warming to a target core temperature of 37°C (aggressively warmed group) or routine thermal management to a target of 35·5°C (routine thermal management group) during non-cardiac surgery. Randomisation was stratified by site, with computer-generated, randomly sized blocks. Eligible patients (aged ≥45 years) had at least one cardiovascular risk factor, were scheduled for inpatient non-cardiac surgery expected to last 2–6 h with general anaesthesia, and were expected to have at least half of the anterior skin surface available for warming. Patients requiring dialysis and those with a body-mass index exceeding 30 kg/m2 were excluded. The primary outcome was a composite of myocardial injury (troponin elevation, apparently of ischaemic origin), non-fatal cardiac arrest, and all-cause mortality within 30 days of surgery, as assessed in the modified intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03111875.

Findings

Between March 27, 2017, and March 16, 2021, 5056 participants were enrolled, of whom 5013 were included in the intention-to-treat population (2507 in the aggressively warmed group and 2506 in the routine thermal management group). Patients assigned to aggressive warming had a mean final intraoperative core temperature of 37·1°C (SD 0·3) whereas the routine thermal management group averaged 35·6°C (SD 0·3). At least one of the primary outcome components (myocardial injury after non-cardiac surgery, cardiac arrest, or mortality) occurred in 246 (9·9%) of 2497 patients in the aggressively warmed group and in 239 (9·6%) of 2490 patients in the routine thermal management group. The common effect relative risk of aggressive versus routine thermal management was an estimated 1·04 (95% CI 0·87–1·24, p=0·69). There were 39 adverse events in patients assigned to aggressive warming (17 of which were serious) and 54 in those assigned to routine thermal management (30 of which were serious). One serious adverse event, in an aggressively warmed patient, was deemed to be possibly related to thermal management.

Interpretation

The incidence of a 30-day composite of major cardiovascular outcomes did not differ significantly in patients ran

DOI: 10.1016/S0140-6736(22)00560-8

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00560-8/fulltext