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临床试验/NCT03068143
NCT03068143Unknown不适用

A Muti-centre Prospective Observational Study on Postoperative Temperature Monitoring In Patients With Brain Trauma

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Change of Brain Temperature

研究概览

简要总结

This prospective observational study is designed to investigate the relationship between brain temperature, axillary temperature, rectal temperature, and bladder temperature of postoperative patients with brain trauma, and the relationship between brain temperature and prognosis. This study is conducted based on the following important assumptions. First, brain temperature of postoperative patients with brain trauma should be higher than the axillary temperature, rectal temperature and bladder temperature. Second, the consistency of brain temperature and bladder temperature is better than the consistency of brain temperature and axillary temperature, as well as that of brain temperature and rectal temperature. Third, brain temperature can help clinicians to predict the prognosis of patients with brain trauma. Therefore, brain temperature monitoring is significant in postoperative intensive care and treatment of patients with brain trauma.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical or radiological diagnosis is brain trauma;
  • The patient has surgical indications, and the patient or his/her family are willing to undergo operation including brain temperature monitoring probe implantation;
  • Informed consent is obtained from the patient's family.

排除标准

  • At the time of admission there are serious systemic diseases, including severe infections, immune system diseases, blood system diseases, infectious diseases, severe liver and kidney dysfunction, malignant tumors, etc;
  • Pregnant or lactating women;
  • There are other brain tumors or cerebrovascular disease in the brain at the same time;
  • There is a history of drug or alcohol abuse;
  • Within 3 months before admission, live vaccines were inoculated.

结局指标

主要结局

Change of Brain Temperature

时间窗: Change from Baseline Brain Temperature at 1 week

Change of Rectal Temperature

时间窗: Change from Baseline Rectal Temperature at 1 week

Change of Bladder Temperature

时间窗: Change from Baseline Bladder Temperature at 1 week

Glasgow Outcome Scale

时间窗: 1 month

An objective assessment of the recovery of patients with brain trauma

Change of Axillary Temperature

时间窗: Change from Baseline Axillary Temperature at 1 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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