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临床试验/NCT07433036
NCT07433036招募中不适用

The Effectiveness of Emergency Room Protocols for Treating Hyperthermia

University of Colorado, Colorado Springs1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Rectal temperature cooling rate

研究概览

简要总结

This study will help us as scientists and clinicians understand how effective commonly used cooling protocols in emergency departments are and which of the protocols is the most effective.

It consists of a single, approximately 1 hour preliminary session and five, approximately 3 hour experimental sessions, equaling an approximate 16 hour total time commitment.

The purpose of this research is to test the effectiveness of three cooling protocols.

  1. Cooling packs
  2. "Ice Sheets", which are bed sheets soaked in ice water, wrapped around the participant, while a fan blows air on them.
  3. Body bag filled with ice, commonly used in emergency departments to treat hyperthermia

Additionally, a negative control (passive cooling in air-conditioned room) and a positive control (cold water immersion).

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active, healthy individuals

排除标准

  • Pregnant or planning on becoming pregnant
  • Have a pacemaker
  • Currently taking any prescribed or over the counter medications or nutritional supplements known to influence thermoregulatory responses
  • Experience lingering pain from a previous musculoskeletal injury (i.e. knee, hip, or back pain)
  • Use tobacco/nicotine products

研究组 & 干预措施

Passive cooling

Active Comparator

Participant lies supine in an air-conditioned room

干预措施: Passive cooling (Procedure)

Cooling packs

Experimental

During recovery, cooling packs are applied on either side of the neck, both underarms, and both sides of the groin

干预措施: Cooling packs (Procedure)

Ice sheets

Experimental

During recovery, participants lie supine and are wrapped in bed sheets that have been soaked in ice water, then have a fan directed towards them while cooling

干预措施: Ice sheets (Procedure)

Body bag full of ice

Experimental

During recovery, participants are zipped into a body bag that is full of ice

干预措施: Body bag cooling (Procedure)

Cold water immersion

Experimental

During recovery, participants are submerged to the neck in a cold water bath

干预措施: Cold water immersion (Procedure)

结局指标

主要结局

Rectal temperature cooling rate

时间窗: The measurement occurs immediately upon completion of the exercise protocol. Time itself is part of the outcome variable and will vary between participants (~3 to 40 min post exercise protocol).

Following termination of the exercise protocol, at a core temperature above 39 degrees Celcius, participants will be cooled until they reach a core temperature of 38 degrees Celcius. The cooling rate in degrees Celcius per minute, is the primary outcome.

次要结局

未报告次要终点

研究者

发起方
University of Colorado, Colorado Springs
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathan Morris

Assistant professor

University of Colorado, Colorado Springs

研究点 (1)

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