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中国循证儿科杂志

中国循证儿科杂志 ›› 2018, Vol. 13 ›› Issue (5): 332-336.

• 论著 • 上一篇    下一篇

直肠亚低温技术目标温度管理能力和安全性临床实验报告

廖敏1,刘鹏2,邓星1,左泽兰1   

  1. 1. 重庆医科大学附属儿童医院
    2.
  • 收稿日期:2018-10-29 修回日期:2018-12-01 出版日期:2018-10-25 发布日期:2018-10-25
  • 通讯作者: 廖敏

A clinical trial report on using a novel rectal cooling device to achieve target temperature management

  • Received:2018-10-29 Revised:2018-12-01 Online:2018-10-25 Published:2018-10-25

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摘要： 目的：建立直肠亚低温技术，考察目标温度管理（TTM）能力和安全性。 方法：本文为病例系列报告，以自制的直肠亚低温装置（中国新型实用专利201320448017.4）对PICU中缺血缺氧性脑损伤并行机械通气的患儿行亚低温治疗，每15 min监测1次，观察TTM（诱导低温、维持低温稳定水平、复温的控制）能力和安全性指标（持续心电监测、粪隐血、血常规等实验室指标和寒战）。 结果：2014年1月14日至2017年12月31日37例缺血缺氧性脑损伤并行机械通气的患儿纳入研究，35例患儿降温阶段共采集到712个鼻咽部温度值，随时间延长诱导低温逐渐达到亚低温状态，最长1例超过14 h,诱导低温时间平均为（4.9±3.8）h，2、4和 6 h达标率分别为31.4%、51.4%和68.6%，平均降温速率为（1.2±0.8）℃·h-1。 34例患儿低温维持阶段共采集到1 632个鼻咽部温度值，1 499（91.9%）个数据平稳维持在32.0~35.0（34.2±0.6）℃亚低温状态12 h。33例患儿复温阶段共采集到1 418个鼻咽部温度值，1 151（81.2%）个数据处于持续复温状态，其中过快66个，偏快175个，正常910个，出现反跳234个（反跳幅度0.1~0.9℃）。直肠亚低温治疗期间心率随体温降低而降低，未出现严重的心律失常和难以纠正的低血压，维持阶段粪潜血阳性25/34例（73.5%），观察到寒战11次，其中在36.0~37.0℃有7例。 结论：经直肠亚低温技术作为一种新TTM方法，控温能力是有效的，实施过程是安全可控的。

关键词: New method, Clinical trial, Efficacy, Safety, Targeted temperature management, 安全性, 临床试验, 目标温度管理, 新方法, 有效性

Abstract: Objective:To establish a new rectal hypothermia technique and investigate its efficacy and safety in target temperature management (TTM). Methods:This case series report applied a self-made rectal hypothermia device to children with ischemic hypoxic brain injury.Nasopharyngeal temperature was recorded every 15 min, and parameters of TTM including hypothermia induction, temperature stability level during the maintenance stage and controllability of rewarming were analyzed. Safety indicators included continuous ECG monitoring, occult blood, blood routine and other laboratory indicators and chills. Results:From January 14, 2014 to December 31, 2017, 37 patients with ischemic hypoxic brain injury in PICU were prospectively enrolled. A total of 712 nasopharyngeal temperature values were collected from 35 cases during the cooling stage, and hypothermia was gradually achieved, with a maximum time of exceeding 14 h. The induction time averaged (4.9±3.8) h, and achievement rates at 2, 4 and 6 h were 31.4%, 51.4% and 68.6%, respectively, with an average cooling rate of (1.19±0.8) ℃·h-1. A total of 1 632 nasopharyngeal temperature values were collected from 34 cases during the maintenance phase, and 1 499/1 632 (91.9%) data were maintained within the target temperature ranging from 33.0~35.0 (34.2±0.6)℃ for 12 hours. A total of 1 418 nasopharyngeal temperature values were collected from 33 cases during the rewarming stage, and 1 151/1 418 (81.2%) of the data were in the continuous rewarming state, of which 66 rapid, 175 abrupt and 910 normal ; there were 234 fallbacks, with an amplitude of 0.1~0.9℃. During the treatment of rectal hypothermia, the heart rate decreased with the decrease of body temperature, and severe arrhythmia or difficult-to-correct hypotension didn't occur. Fecal occult blood tests were positive in 25/34 cases (73.5%) during the maintenance stage. Chills were observed 11 times, of which 7 occurred between 36.0 and 37.0℃. Conclusion:As a new TTM method, rectal hypothermia technique is effective and the implementation process is safe and controllable.