Postoperative Temperature Monitoring In Brain Trauma

Brain Injuries, Traumatic Clinical Trial

— PTMIBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03068143
• Other study ID #: BT-201607
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2017
• Last updated: February 24, 2017
• Start date: March 2017
• Est. completion date: February 2018

Study information

• Verified date: February 2017
• Source: RenJi Hospital
• Contact: Guoyi Gao, Dr.
• Phone: +86-021-68383709
• Email: guoyigao[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Temperature Changes
• Brain Injuries
• Brain Injuries, Traumatic

Locations

Country	Name	City	State
China	Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Camboni D, Philipp A, Schebesch KM, Schmid C. Accuracy of core temperature measurement in deep hypothermic circulatory arrest. Interact Cardiovasc Thorac Surg. 2008 Oct;7(5):922-4. doi: 10.1510/icvts.2008.181974. — View Citation

Hayward JN, Baker MA. A comparative study of the role of the cerebral arterial blood in the regulation of brain temperature in five mammals. Brain Res. 1969 Dec;16(2):417-40. — View Citation

Henker RA, Brown SD, Marion DW. Comparison of brain temperature with bladder and rectal temperatures in adults with severe head injury. Neurosurgery. 1998 May;42(5):1071-5. — View Citation

Hirashima Y, Takaba M, Endo S, Hayashi N, Yamashita K, Takaku A. Intracerebral temperature in patients with hydrocephalus of varying aetiology. J Neurol Neurosurg Psychiatry. 1998 Jun;64(6):792-4. — View Citation

Mellergård P, Nordström CH, Messeter K. Human brain temperature during anesthesia for intracranial operations. J Neurosurg Anesthesiol. 1992 Apr;4(2):85-91. — View Citation

Mellergård P, Nordström CH. Intracerebral temperature in neurosurgical patients. Neurosurgery. 1991 May;28(5):709-13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Brain Temperature		Change from Baseline Brain Temperature at 1 week
Primary	Change of Axillary Temperature		Change from Baseline Axillary Temperature at 1 week
Primary	Change of Rectal Temperature		Change from Baseline Rectal Temperature at 1 week
Primary	Change of Bladder Temperature		Change from Baseline Bladder Temperature at 1 week
Primary	Glasgow Outcome Scale	An objective assessment of the recovery of patients with brain trauma	1 month