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Postoperative Temperature Monitoring In Brain Trauma (PTMIBT)

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ClinicalTrials.gov Identifier: NCT03068143
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

February 21, 2017
March 1, 2017
March 1, 2017
March 2017
December 2017   (Final data collection date for primary outcome measure)
  • Change of Brain Temperature [ Time Frame: Change from Baseline Brain Temperature at 1 week ]
  • Change of Axillary Temperature [ Time Frame: Change from Baseline Axillary Temperature at 1 week ]
  • Change of Rectal Temperature [ Time Frame: Change from Baseline Rectal Temperature at 1 week ]
  • Change of Bladder Temperature [ Time Frame: Change from Baseline Bladder Temperature at 1 week ]
  • Glasgow Outcome Scale [ Time Frame: 1 month ]
    An objective assessment of the recovery of patients with brain trauma
Same as current
No Changes Posted
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Postoperative Temperature Monitoring In Brain Trauma
A Muti-centre Prospective Observational Study on Postoperative Temperature Monitoring In Patients With Brain Trauma
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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
the patients with brain trauma
  • Brain Injuries, Traumatic
  • Body Temperature Changes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
February 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact: Guoyi Gao, Dr. +86-021-68383709 guoyigao@gmail.com
China
 
 
NCT03068143
BT-201607
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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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RenJi Hospital
RenJi Hospital
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RenJi Hospital
February 2017