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临床试验/NCT03643835
NCT03643835已完成不适用

Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals

University of North Carolina, Greensboro2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Change in Internal Body Temperature

研究概览

简要总结

Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C with the presence of central nervous dysfunction (altered mental status). The gold standard method of care for EHS is immediate onsite whole body cooling using cold-water immersion (cooling rates >0.15°C•min-1), which is reported to have the highest cooling rate. In the treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°C to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. However, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. In this proposed study, the investigators aim to examine the cooling rates of the Polar Breeze® device (developed by Statim Technologies, LLC, Clearwater, FL) compared to rotating ice towels, a cooling method often recommended by sports medicine professionals as an alternative to cold-water immersion, and passive rest in participants with exercise-induced hyperthermia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • male between the ages of 18-
  • recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session)

排除标准

  • chronic health problems,
  • fever or current illness at the time of testing
  • history of cardiovascular, metabolic, or respiratory disease
  • current musculoskeletal injury that limits physical activity
  • history of exertional heat illness in the past three years.

研究组 & 干预措施

Thermal rehab machine

Experimental

Participants, following exercise-induced hyperthermia, will be cooled using a Thermal Rehab Machine (Polar Breeze, Statim Technologies, LLC, Clearwater Florida), which is a micro-environmental air chiller. The device will be placed over the subjects head and through trans pulmonary cooling, will cool the body.

干预措施: Thermal Rehab Machine (Device)

Forearm Ice Towels

Active Comparator

Participants, following exercise-induced hyperthermia, will be cooled using forearm ice towels. Cotton-blend towels will be doused in ice-water and then wrapped around participant's forearms (elbow to wrist). The towels will be rotated (re-wetted) every 2 minutes)

干预措施: Forearm Ice Towels (Other)

Passive Cooling

No Intervention

Participants, following exercise-induced hyperthermia, will undergo a period of passive rest to allow the body to cool via natural mechanisms of evaporation of sweat from the skin's surface and convection

结局指标

主要结局

Change in Internal Body Temperature

时间窗: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes post onset of cooling

The rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia.

次要结局

未报告次要终点

研究者

发起方
University of North Carolina, Greensboro
申办方类型
Other
责任方
Principal Investigator
主要研究者

William Adams

Assistant Professor

University of North Carolina, Greensboro

研究点 (2)

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