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Clinical Trials/NCT03068143
NCT03068143
Unknown
Not Applicable

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

RenJi Hospital1 site in 1 country150 target enrollmentMarch 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries, Traumatic
Sponsor
RenJi Hospital
Enrollment
150
Locations
1
Primary Endpoint
Change of Brain Temperature
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2017
End Date
February 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change of Brain Temperature

Time Frame: Change from Baseline Brain 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

Change of Axillary Temperature

Time Frame: Change from Baseline Axillary Temperature at 1 week

Study Sites (1)

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