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Targeted Temperature Management Via Bladder Monitoring in ICH
Sponsor: Yanyan Gong
Summary
The goal of this clinical trial is to learn whether a bladder temperature monitoring-guided targeted temperature management (TTM) strategy improves functional recovery in patients with severe intracerebral hemorrhage, compared to conventional temperature monitoring. It will also assess the safety of this monitoring approach. The main questions it aims to answer are: * Does continuous bladder temperature monitoring-guided TTM improve the likelihood of a favorable functional outcome (modified Rankin Scale score 0-2) at 180 days after onset? * What medical problems (such as infections, shivering, deep vein thrombosis, or sepsis) do participants experience while under the TTM strategy? Researchers will compare the intervention group (using continuous bladder temperature monitoring) with the control group (using conventional intermittent temperature monitoring with a mercury thermometer at the armpit) to see if the bladder temperature-guided TTM strategy leads to better outcomes. Participants will: * Be randomly assigned to one of the two temperature monitoring strategies * Receive standard medical and surgical care for severe intracerebral hemorrhage
Official title: Safety and Efficacy of Bladder Temperature Monitoring-Guided Targeted Temperature Management in Patients With Severe : A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
308
Start Date
2026-01-20
Completion Date
2027-12-30
Last Updated
2025-12-24
Healthy Volunteers
No
Interventions
Bladder Temperature Monitoring
This intervention utilizes a single-use, sterile, thermometric silicone urinary catheter that, upon insertion, provides continuous, real-time measurement of core body temperature, which is used to dynamically guide all phases of Targeted Temperature Management (TTM).
Standard Temperature Monitoring Group
Axillary temperature is measured intermittently using a mercury-in-glass thermometer. The thermometer is placed in the axilla for a standardized period (e.g., 5-10 minutes) to obtain a reading. Temperature data is recorded every 4 hours and is used to guide adjustments in Targeted Temperature Management (TTM) therapy.