Postoperative Temperature Monitoring In Brain Trauma

• Conditions: Brain Injuries, Traumatic; Body Temperature Changes

• Registration Number: NCT03068143
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-24
• Last Update Submitted: 2017-02-24
• Study Start: 2017-03
• Study First Posted: 2017-03-01
• Last Update Posted: 2017-03-01
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Brain Temperature	Change from Baseline Brain Temperature at 1 week
Change of Rectal Temperature	Change from Baseline Rectal Temperature at 1 week
Change of Bladder Temperature	Change from Baseline Bladder Temperature at 1 week
Glasgow Outcome Scale	1 month	An objective assessment of the recovery of patients with brain trauma
Change of Axillary Temperature	Change from Baseline Axillary Temperature at 1 week

Trial Locations

Locations (1)

Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China