Clinical trial NCT03068143: Postoperative Temperature Monitoring In Brain Trauma
Official title: A Muti-centre Prospective Observational Study on Postoperative Temperature Monitoring In Patients With Brain Trauma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries, Traumatic
Body Temperature Changes
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients with brain trauma

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.


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.

Primary outcomes:
measure: Change of Brain Temperature
timeFrame: Change from Baseline Brain Temperature at 1 week
measure: Change of Axillary Temperature
timeFrame: Change from Baseline Axillary Temperature at 1 week
measure: Change of Rectal Temperature
timeFrame: Change from Baseline Rectal Temperature at 1 week
measure: Change of Bladder Temperature
timeFrame: Change from Baseline Bladder Temperature at 1 week
measure: Glasgow Outcome Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
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. doi: 10.1016/0006-8993(69)90236-4. No abstract available.
citation: Mellergard P, Nordstrom CH. Intracerebral temperature in neurosurgical patients. Neurosurgery. 1991 May;28(5):709-13.
citation: Mellergard P, Nordstrom CH, Messeter K. Human brain temperature during anesthesia for intracranial operations. J Neurosurg Anesthesiol. 1992 Apr;4(2):85-91. doi: 10.1097/00008506-199204000-00003.
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. doi: 10.1136/jnnp.64.6.792.
citation: 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. Epub 2008 Jul 25.
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. doi: 10.1097/00006123-199805000-00071.
citation: Weng WJ, Yang C, Huang XJ, Zhang YM, Liu JF, Yao JM, Zhang ZH, Wu XS, Mei T, Zhang CD, Jia J, Shi XF, Mao Q, Feng JF, Gao GY, Jiang JY. Effects of Brain Temperature on the Outcome of Patients with Traumatic Brain Injury: A Prospective Observational Study. J Neurotrauma. 2019 Apr 1;36(7):1168-1174. doi: 10.1089/neu.2018.5881. Epub 2018 Oct 10.