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

NCT ID: NCT05923931

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-28

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heat Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

non-cooling blanket group

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

Group Type EXPERIMENTAL

non-cooling blanket

Intervention Type DEVICE

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.

Cooling blanket group

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℃.

Group Type ACTIVE_COMPARATOR

cooling blanket

Intervention Type DEVICE

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℃.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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℃.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yiwu Central Hospital

OTHER

Sponsor Role collaborator

Jinhua People's Hospital

UNKNOWN

Sponsor Role collaborator

Jinhua Municipal Central Hospital

OTHER

Sponsor Role collaborator

Dongyang People's Hospital

OTHER

Sponsor Role collaborator

Lanxi People's Hospital

OTHER

Sponsor Role collaborator

Hangzhou Medical College

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lan Chen

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yongkang First People's Hospital

Guli, Zhejiang, China

Site Status RECRUITING

Yiwu Central Hospital

Yiwu, Zhejiang, China

Site Status RECRUITING

Dongyang People's Hospital

Dongyang, , China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, , China

Site Status RECRUITING

Jinhua Municipal Central Hospital

Jinhua, , China

Site Status RECRUITING

Jinhua People's Hospital

Jinhua, , China

Site Status RECRUITING

Lanxi People's Hospital

Lanxi, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiuqin Feng

Role: CONTACT

+8613757119151

Lan Chen

Role: CONTACT

+8613819987120

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Huimin Ma

Role: primary

86-0579-7111834

Zhumei Gong

Role: primary

Shuying Xu

Role: primary

Xiuqin Feng

Role: primary

+8613757119151

Lan Chen

Role: backup

+8613819987120

Sunying Wu

Role: primary

Liyun Lu

Role: primary

Xiaoling Yang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-0508

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cooling Solutions for Outdoor Workers
NCT06998667 ENROLLING_BY_INVITATION NA