Non-inferiority Study of the Effect of Non-cooling Blanket on Body Temperature in Patients With Heat Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cooling blanket, non-cooling blanket.
- Who it may be relevant to
- Registry conditions: Heat Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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℃. - Device non-cooling blanket
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, convection,etc.
Primary outcome measures
- 0.5-hour temperature reduction [Time frame: 0.5 hours]
- Body temperature of 0.5 hours [Time frame: 0.5 hours after admission to emergency department]
Secondary outcome measures (4)
- Body temperature of 2 hours [Time frame: 2 hours]
- incidence of organ damage [Time frame: up to 90 days]
- length of ICU stay [Time frame: up to 90 days]
- in-hospital mortality [Time frame: up to 90 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
China · 7 centers
- Yongkang No.1 People's Hospital — Guli
- Yiwu Central Hospital — Yiwu
- Dongyang People's Hospital — Dongyang
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
- Jinhua Municipal Central Hospital — Jinhua
- Jinhua People's Hospital — Jinhua
- Lanxi People's Hospital — Lanxi
Identifiers
NCT: NCT05923931 · 2023-0508