Actively Recruiting
Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-05-27
126
Participants Needed
7
Research Sites
21 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
Y
Yiwu Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial investigates the cooling effect of a cooling blanket in patients diagnosed with heat stroke. The study aims to determine the cooling rate of the cooling blanket and its relationship with patient outcomes, including prognosis improvement. Researchers want to see if using the cooling blanket can speed up body temperature reduction compared to standard cooling methods. Participants will be randomly assigned to one of two groups. One group receives standard cooling methods such as controlling emergency room temperature, fluid infusion at 46C, ice packs, evaporation, and convection without a cooling blanket. The other group receives the same standard cooling methods combined with a cooling blanket activated within 30 minutes of admission, set to 4-106C, targeting a body temperature of 386C. During the study, participants' body temperatures will be measured at 0.5 hours and 2 hours after admission to the emergency department. Researchers will also monitor incidence of organ damage, length of ICU stay, and in-hospital mortality up to 90 days. The study evaluates the cooling speed and overall outcomes to compare the effectiveness of the cooling blanket versus non-cooling blanket methods.
CONDITIONS
Brief Title
Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Diagnosed with heat stroke
- Informed consent provided by patient or family members
You will not qualify if you...
- Need immediate cardiopulmonary resuscitation
- Body temperature below 39.56C on admission
- Severe organ damage from underlying disease
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 hours after admission
Participants receive cooling interventions to reduce body temperature after admission to the emergency department, either with or without a cooling blanket.
1 baseline visit (in-person) within 30 minutes of admission
Duration - Up to 90 days
Participants are monitored for organ damage, ICU stay length, and in-hospital mortality over 90 days after treatment.
Periodic visits or assessments as needed during hospital stay and follow-up
Trial Site Locations
Total: 7 locations
1
Yongkang No.1 People's Hospital
Guli, Zhejiang, China, 321300
Actively Recruiting
2
Yiwu Central Hospital
Yiwu, Zhejiang, China
Actively Recruiting
3
Dongyang People's Hospital
Dongyang, China
Actively Recruiting
4
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China, 310000
Actively Recruiting
5
Jinhua Municipal Central Hospital
Jinhua, China
Actively Recruiting
6
Jinhua People's Hospital
Jinhua, China
Actively Recruiting
7
Lanxi People's Hospital
Lanxi, China
Actively Recruiting
Research Team
X
Xiuqin Feng
L
Lan Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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