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临床试验/NCT05717777
NCT05717777进行中(未招募)不适用

Treatment of Exertional Heatstroke witH icE wAter Soaked Towels

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
55
试验地点
1
主要终点
cooling rate

研究概览

简要总结

Exertional heat stroke (EHS) is the most serious form of heat-illness that can occur during sports and exercise. If not recognized and treated immediately mortality rate of EHS is high. Early recognition and initiation of cooling are paramount. If temperature is reduced to < 40°C within 30 minutes of symptom onset, most patients recover completely. There are several strategies for cooling in EHS, including cooling with rotating in ice water soaked towels which cover the body of a patient.

The aim of this research is to investigate the effectiveness and safety of treatment of EHS with ice water soaked towels to lower body temperature.

详细描述

Rationale: Exertional heat stroke (EHS) is the most serious form of heat-illness that can occur during sports and exercise. If not recognized and treated immediately mortality rate of EHS is high. Early recognition and initiation of cooling are paramount. If temperature is reduced to < 40°C within 30 minutes of symptom onset, most patients recover without sequelae. Exertional heat exhaustion (EHE) is a precursor of EHS, and might develop in EHS if exercise is not terminated. There are several strategies for cooling in EHS, including cooling with rotating in ice water soaked towels which cover the body of a patient.

Objective: The aim of this research is to investigate the effectiveness and safety of treatment of EHS with ice water soaked towels to lower body temperature. Secondary objectives include cooling rate of ice water soaked towels, morbidity of EHS and HE, productivity loss related to EHS and EHE and the development of posttraumatic stress symptoms and PTSD after treatment for EHS and EHE.

Study design: We will conduct a prospective longitudinal observational study. Patients will be monitored and treated according the national guideline in the medical facility. A follow-up survey will be performed after two weeks and two months.

Study population: All participants of 18 years and older who received medical care for EHS or EHE at the City Pier City race on March 12th 2023 and Rotterdam Marathon on April 16th 2023.

Main study parameters/endpoints: Primary outcome will be the cooling rate of treatment with rotating in ice water soaked towels. Secondary outcomes will be percentage of patients with EHS that were cooled to a temperature lower than 40°C within 30 minutes after entering a medical facility (or collapse).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • ≥18 years
  • Receive medical care at in the medical facility the City Pier City and Marathon Rotterdam 2023
  • Tympanic temperature >38.0°C

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Language barrier (not proficient in Dutch or English)

结局指标

主要结局

cooling rate

时间窗: during treatment in medical facility up to 2 hours after entering the facility

cooling rate of treatment with rotating in ice water soaked towels

次要结局

  • productivity loss (abscens of work) related to EHS and EHE(2 months after EHS/EHE)
  • Morbidity of EHS/EHE(2 weeks and 2 months after EHS/EHE)
  • Posttraumatic stress symptoms after EHS and EHE(6 months after EHS/EHE)
  • percentage cooled to a temperature <40°C within 30 minutes(30 minutes after entering medical facility)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amber Hoek

Principal Investigator, Emergency Physician, MD, PhD

Erasmus Medical Center

研究点 (1)

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