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使用Humigard®开放手术加湿系统预防原位肝移植患者体温过低:一项前瞻性随机先导性可行性临床试验。

Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

作者信息

Weinberg Laurence, Huang Andrew, Alban Daniel, Jones Robert, Story David, McNicol Larry, Pearce Brett

机构信息

Department of Surgery, and Anaesthesia Perioperative and Pain Medicine Unit, The University of Melbourne, Melbourne, Australia.

Department of Anaesthesia, Austin Hospital, Heidelberg, Australia.

出版信息

BMC Surg. 2017 Jan 23;17(1):10. doi: 10.1186/s12893-017-0208-z.

Abstract

BACKGROUND

Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis.

METHODS

We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO, minute ventilation and the use of vasoconstrictors.

RESULTS

Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO, PaCO, minute ventilation, or inotropic support.

CONCLUSION

The humidified high flow CO warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes.

TRIAL REGISTRATION

ACTRN12616001631493 . Retrospectively registered 25 November 2016.

摘要

背景

原位肝移植(OLT)围手术期的体温紊乱很常见。我们假设,与维持体温调节稳态的标准化多模式策略相比,在接受OLT的患者中使用高流量二氧化碳加湿保暖系统可使术中体温维持在较高水平。

方法

我们对接受初次OLT的成年患者进行了一项随机试验性研究。参与者被随机分为两组,一组在标准护理基础上接受高流量二氧化碳加湿保暖系统进行开放性伤口加湿(加湿组),另一组仅接受标准护理(对照组)。主要终点是在供肝再灌注前5分钟(第3阶段-5分钟)测量的鼻咽核心温度。次要终点包括术中呼气末二氧化碳分压(ETCO₂)、分钟通气量和血管收缩剂的使用情况。

结果

每组随机分配了11名患者。两组在年龄、体重指数、终末期肝病模型(MELD)评分、序贯器官衰竭评估(SOFA)评分和急性生理与慢性健康状况评分系统II(APACHE II)评分、基线体温及手术时长方面相似。在再灌注前即刻(第3阶段-5分钟),加湿组的平均(标准差)核心温度高于对照组:36.0℃(0.13) vs. 35.4℃(0.22),p = 0.028。重复测量方差分析显示,在移植各阶段,加湿组随时间变化的核心温度高于对照组(p < 0.0001)。在呼气末二氧化碳分压(ETCO₂)、动脉血二氧化碳分压(PaCO₂)、分钟通气量或血管活性药物支持方面无显著差异。

结论

在维持接受OLT患者的正常体温方面,高流量二氧化碳加湿保暖系统优于标准化多模式策略。该设备的使用是可行的,且不干扰手术的任何方面。需要开展更大规模的研究来调查所观察到的体温调节改善是否与患者预后改善相关。

试验注册

澳大利亚新西兰临床试验注册中心(ACTRN)12616001631493。于2016年11月25日进行回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d5d/5260131/68ba4c57cd85/12893_2017_208_Fig1_HTML.jpg

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