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

Zhejiang University

Status: Enrolling

Conditions: Heat Stroke

Treatments: Device: cooling blanket; Device: non-cooling blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT05923931

2023-0508

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

non-cooling blanket group

Experimental group

Description:

Cooling body temperature by: control the temperature of the emergency room to 20-24℃, 4℃ fluid infusion, ice packs, evaporation, convection, etc.

Treatment:

Device: non-cooling blanket

Cooling blanket group

Active Comparator group

Description:

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℃.

Treatment:

Device: cooling blanket