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Targeted Temperature Management Via Bladder Monitoring in ICH

RecruitingNAAges 18 Years - 85 YearsAllYanyan Gong
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In plain words

What the trial is, and whether it could suit you

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 t

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Neurocritical care patients: Study subjects are patients with first-time spontaneous intracerebral hemorrhage. 2. Age โ‰ฅ 18 years and โ‰ค 85 years. 3. Glasgow Coma Scale (GCS) score โ‰ค 8 at ICU admission. 4. For supratentorial ICH: Hematoma volume \< 60 mL. For subarachnoid hemorrhage (SAH): Modified Fisher grade โ‰ฅ 2, and the aneurysm has been treated with endovascular intervention. 5. Pre-morbid modified Rankin Scale (mRS) score of 0 or 1. 6. Signed informed consent provided by a legally authorized representative. Exclusion Criteria: 1. Fever (โ‰ฅ38.0ยฐC) that lasted over 1 hour or occurred more than once prior to enrollment. 2. Pre-existing neurological, psychiatric, or other comorbidities that may compromise the assessment of neurological or functional outcomes. 3. Underlying conditions with a life expectancy of less than 6 months, estimated prior to onset. 4. Severe injury indicative of poor prognosis: brain death, receiving palliative care only, or irreversible brain injury. 5. Pregnancy. 6. Unilateral or bilateral pupillary dilation. 7. Currently participating in other investigational/interventional clinical trials (involving medical devices or drugs). 8. Subjects deemed ineligible for enrollment by the investigator.
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What it tests

  • Bladder Temperature Monitoring
  • Standard Temperature Monitoring Group
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Where

1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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