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临床试验/NCT02685176
NCT02685176已完成不适用

Efficacy of Head and Torso Rewarming by Using a Human Model for Severe Hypothermia

University of Manitoba2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Rewarming Rate

研究概览

简要总结

This Clinical trial is being conducted to study the effectiveness of heat donation through head or torso in hypothermic rewarming efficacy using a human model for severe hypothermia. The purpose of the study is to compare the core rewarming effectiveness of the same amount of heat donation through the head or torso in treatment of hypothermia using a human model for severe hypothermia. The information obtained from this study will give a better understanding of heat-transfer mechanisms. This might help in the ongoing research in hypothermia treatment.

详细描述

Procedure:

Eight healthy, non-pregnant participants between 18 and 45 years old will be cooled in 8°C water, for 60 minutes or to a core temperature of 35ºC on three occasions and then warmed by each of three warming conditions.

The study will include following specific procedures:

Anthropometric data which includes age, weight, height, and measurements of skinfold thickness at four sites- biceps, triceps, subscapularis, and suprailiac will be collected. Participant's heart rate and electrocardiogram will be monitored continuously throughout the experiment.

Conditions: The three treatment methods are as follows. A. Spontaneous rewarming (Shivering inhibition) In this control condition, Demerol will be infused through the arm or hand vein.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults, who answer "No" to all the questions on a Physical Activity Readiness Questionnaire (PAR-Q). Participants will also be interviewed to determine if they have any cardio-respiratory diseases, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure.

排除标准

  • A positive answer to any PAR-Q question, or any cardio-respiratory diseases, Renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure.

研究组 & 干预措施

No Heat

Experimental

No active heating will be provided post cooling

干预措施: No heat (Other)

Head

Experimental

Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the head following cooling

干预措施: Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.) (Device)

Torso

Experimental

Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the torso following cooling

干预措施: Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.) (Device)

结局指标

主要结局

Rewarming Rate

时间窗: 120 minutes

Rate of core temperature increase during rewarming

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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