Tokyo, June 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061998) titled 'A Study on the Effect of Cooling Devices in Firefighting Operations on Suppressing Core Body Temperature and Reducing the Risk of Heat Stroke' on June 22.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - University of Occupational and Environmental Health
Condition:
Condition - Heat Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the effects of localized cooling of the neck and forearms on firefighters during firefighting operations and rest periods. With the cooperation of the Osaka City Fire Department, we will conduct a comprehensive evaluation by measuring physiological indicators (vital signs such as core body temperature), cognitive and psychological indicators (cognitive function tests, voice emotion analysis), and subjective indicators (rating of perceived exertion) of active-duty firefighters in a combustion test environment simulating actual firefighting operations.
The significance of this study lies in identifying simple and effective localized cooling methods applicable during firefighting operations, which can contribute to on-site implementation as measures to reduce the risk of heatstroke. Furthermore, this study will clarify the effects of localized cooling interventions not only on physical recovery but also on the restoration of cognitive and mental functions, thereby contributing to the development of scientifically grounded safety management methods and injury prevention measures for firefighters.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Chest and back cooling using cooling vests (with ice packs)* during firefighting operations
*: Cooling vests routinely used by the Osaka City Fire Department
Interventions/Control_2 - Combined use of Peltier-type cooling devices for neck cooling during firefighting operations and rest periods, and for forearm cooling during rest periods
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Current fire department personnel
2. Individuals who have undergone a routine health examination (including a comprehensive health screening) within the past year
3. Individuals who have received a thorough explanation of the purpose, content, and risks of this study and have provided written consent
Key exclusion criteria - 1. Individuals with a history or current diagnosis of hypertension, heart disease, respiratory disease, kidney disease, diabetes, or similar conditions
2. Individuals currently taking medications that affect body temperature regulation or circulatory function
3. Individuals with abnormalities or medical conditions at the site where the measurement device will be attached
4. Individuals for whom the principal investigator determines are unsuitable based on the medical interview and vital sign check conducted on the day of the experiment, due to fever, lack of sleep, excessive fatigue, residual alcohol, or other factors
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 13 Day
Anticipated trial start date - 2026 Year 04 Month 22 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070281
Disclaimer: Curated by HT Syndication.
