Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke

Not Applicable

Recruiting

• Conditions: Heat Stroke
• Interventions: Device: non-cooling blanket; Device: cooling blanket

• Registration Number: NCT05923931
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

The goal of this clinical trial is to test the cooling effect of cooling blanket in patients with heat stroke. The main questions it aims to answer are:

* the cooling rate of cooling blanket in patients with heat stroke

* the relationship between cooling blanket and outcomes in patients with heat stroke

Participants will accept the cooling blanket or non-cooling blanket according to the randomization group.

Researchers will compare cooling rate and outcomes to see if the cooling blanket can accelerate the cooling speed and improve the prognosis of patients in heat stroke.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-23
• Study Start: 2023-05-28
• Study First Submitted QC: 2023-06-20
• Last Update Submitted: 2023-06-20
• Study First Posted: 2023-06-28
• Last Update Posted: 2023-06-28
• Primary Completion: 2025-10
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• ≥ 18 years old
• diagnosed as heat stroke
• informed consent of patients or family members

Exclusion Criteria

• need immediate cardiopulmonary resuscitation
• body temperature <39.5℃ on admission
• with the underlying disease of severe organ damage
• pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-cooling blanket group	non-cooling blanket	Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, convection, etc.
Cooling blanket group	cooling blanket	On the basis of the cooling methods of non-cooling blanket group, combine the cooling blanket to cool down. The cooling blanket is required to be activated within 30min after admission. The blanket temperature will be set at 4-10℃, and the target body temperature is 38℃.

Primary Outcome Measures

Name	Time	Method
cooling rate at 0.5 hours	0.5 hours	The cooling rate of 0.5h was calculated by the initial temperature and the 0.5 hours temperature.
Body temperature of 0.5 hours	0.5 hours after admission to emergency department	Body temperature of 0.5 hours referred to the temperature value obtained 5 min before and after 0.5 hour.

Secondary Outcome Measures

Name	Time	Method
Body temperature of 2 hours	2 hours	Body temperature of 2 hours referred to the temperature value obtained 20 min before and after 2 hours.
incidence of organ damage	up to 90 days	number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver, and coagulation function
length of ICU stay	up to 90 days	The length patient stay at ICU
in-hospital mortality	up to 90 days	number of participants dead in-hospital

Trial Locations

Locations (7)

Yongkang First People&#39;s Hospital; 🇨🇳 Yongkang, Zhejiang, China

Yiwu Central Hospital; 🇨🇳 Yiwu, Zhejiang, China

Dongyang People's Hospital; 🇨🇳 Dongyang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Jinhua Municipal Central Hospital; 🇨🇳 Jinhua, China

Jinhua People's Hospital; 🇨🇳 Jinhua, China

Lanxi People's Hospital; 🇨🇳 Lanxi, China