Abstract
IntroductionAnimal 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.MethodsThe 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.ResultsThe 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.ConclusionsCooling 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.Trial RegistrationISRCTN: ISRCTN50530495
Highlights
Animal and human studies suggest beneficial outcome effects of mild hypothermia for stroke, for acute myocardial infarction, and for cardiogenic shock
The majority of therapeutic hypothermia research has involved cardiac arrest patients, in whom the induction and maintenance of mild hypothermia is facilitated by post-anoxic coma, anesthesia and paralysis to avoid shivering
The typical patient presenting to an emergency department with ischemic stroke or acute myocardial infarction is awake and does not present in a clinical status that necessitates intubation and neuromuscular blockade
Summary
Animal and human studies suggest beneficial outcome effects of mild hypothermia for stroke, for acute myocardial infarction, and for cardiogenic shock. In recent years, growing evidence in animal and human studies have documented or suggested the beneficial outcome effects of mild hypothermia for stroke [3,4,5,6,7,8,9,10,11], for acute myocardial infarction [12,13,14,15,16], and for cardiogenic shock [17]. A simple to use, non invasive cooling pad, independent of an energy source during use, was developed, which proved to rapidly induce mild hypothermia in patients after cardiac arrest in the out-of-hospital setting [34] and in the emergency department [35]
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