Postoperative Temperature Monitoring In Brain Trauma

NCT03068143 | Unknown

• 1 other identifier: BT-201607
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic; Body Temperature Changes

Outcome Measures

Primary Outcomes (5)

• Change of Brain Temperature

  Change from Baseline Brain Temperature at 1 week

• Change of Axillary Temperature

  Change from Baseline Axillary 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

  An objective assessment of the recovery of patients with brain trauma

  1 month

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patients with brain trauma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 4311724 BACKGROUND

• Mellergard P, Nordstrom CH. Intracerebral temperature in neurosurgical patients. Neurosurgery. 1991 May;28(5):709-13.

  PMID: 1876249 BACKGROUND

• 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.

  PMID: 15815447 BACKGROUND

• 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.

  PMID: 9647313 BACKGROUND

• 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.

  PMID: 18658167 BACKGROUND

• 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.

  PMID: 9588552 BACKGROUND

• 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.

  PMID: 30215286 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Body Temperature Changes

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guoyi Gao, Dr.

CONTACT

+86-021-68383709; guoyigao@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 1, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

CN (1)