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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heat Stroke

Intervention / Treatment
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* Device: cooling blanket
* Device: non-cooling blanket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-cooling blanket group<br>Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, etc. | Device: non-cooling blanket<br>* Patients do not receive cooling blanket according to randomization. Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, etc.<br>|
| Active Comparator: Cooling blanket group<br>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℃. | Device: cooling blanket<br>* 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℃.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the scale of drop in temperature within 2 h | The gap between the initial body temperature and the 2-hour body temperature | 2 hours after admission to emergency department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of organ damage | number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver, and coagulation function | up to 90 days | 
| length of ICU stay | The length patient stay at ICU | up to 90 days | 
| in-hospital mortality | number of participants dead in-hospital | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heat stroke, cooling blanket, cooling rate, outcomes