Targeted Temperature Management Via Bladder Monitoring in ICH

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Percentage of patients with mRS 0-2 at 180 days post-onset — 180 days post-onset（±14 days）
  The proportion of participants achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0 to 2, at 180 days (±14 days) post-onset. The mRS is a standardized measure of neurological disability ranging from 0 (no symptoms) to 6 (death). A score of 0-2 represents a favorable functional outcome.

Trial sites (1)

Other trials for the same condition