Department of Emergency Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.
Crit Care. 2011;15(5):R248. doi: 10.1186/cc10506. Epub 2011 Oct 22.
Animal and human studies suggest beneficial outcome effects of mild hypothermia for stroke, for acute myocardial infarction, and for cardiogenic shock. The aim of this study was to investigate the feasibility and safety of non-invasive surface cooling for induction and maintenance of mild hypothermia (32 to 34°C) in healthy, conscious volunteers.
The trial was set at a clinical research ward in a tertiary care center, and included 16 healthy male volunteers 18 to 70 years old. Surface cooling was established by a novel non-invasive cooling pad with an esophageal target temperature of 32 to 34°C and maintenance for six hours. Shivering-control was achieved with meperidine and buspirone and additional administration of magnesium in eight subjects.
The primary endpoint to reach a target temperature of 32 to 34°C was only reached in 6 of the 16 participating subjects. Temperatures below 35°C were reached after a median cooling time of 53 minutes (38 to 102 minutes). Cooling rate was 1.1°C/h (0.7 to 1.8°C). Additional administration of magnesium had no influence on cooling rate. At no time during the cooling procedure did the participants report uncomfortable conditions for which termination of cooling had to be considered. No severe skin damage was reported.
Cooling to body temperature below 35°C by the use of non-invasive surface cooling is feasible and safe in conscious healthy volunteers. Further studies are needed to investigate an altered cooling protocol to achieve temperatures below 35°C.
ISRCTN: ISRCTN50530495.
动物和人体研究表明，轻度低温对中风、急性心肌梗死和心源性休克有有益的疗效。本研究旨在探讨非侵入性体表冷却在健康、清醒志愿者中诱导和维持轻度低温（32 至 34°C）的可行性和安全性。
该试验在三级护理中心的临床研究病房进行，共纳入 16 名年龄在 18 至 70 岁之间的健康男性志愿者。通过一种新型非侵入性冷却垫，将食管目标温度设定在 32 至 34°C，并维持 6 小时，从而实现体表冷却。在 8 名受试者中，使用哌替啶和丁螺环酮控制寒战，并额外给予镁。
仅 16 名参与受试者中的 6 名达到了目标温度 32 至 34°C。中位数冷却时间为 53 分钟（38 至 102 分钟）后，温度降至 35°C 以下。冷却速率为 1.1°C/h（0.7 至 1.8°C）。额外给予镁对冷却速率没有影响。在冷却过程中，没有一名参与者报告出现不适症状，需要考虑终止冷却。没有报告出现严重的皮肤损伤。
在清醒的健康志愿者中，使用非侵入性体表冷却将体温降至 35°C 以下是可行且安全的。需要进一步研究改变冷却方案以达到 35°C 以下的温度。
ISRCTN: ISRCTN50530495。
