Postoperative Temperature Monitoring In Brain Trauma (PTMIBT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03068143
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Information provided by (Responsible Party):
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.

Condition or disease
Brain Injuries, Traumatic Body Temperature Changes

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Muti-centre Prospective Observational Study on Postoperative Temperature Monitoring In Patients With Brain Trauma
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change of Brain Temperature [ Time Frame: Change from Baseline Brain Temperature at 1 week ]
  2. Change of Axillary Temperature [ Time Frame: Change from Baseline Axillary Temperature at 1 week ]
  3. Change of Rectal Temperature [ Time Frame: Change from Baseline Rectal Temperature at 1 week ]
  4. Change of Bladder Temperature [ Time Frame: Change from Baseline Bladder Temperature at 1 week ]
  5. Glasgow Outcome Scale [ Time Frame: 1 month ]
    An objective assessment of the recovery of patients with brain trauma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the patients with brain trauma

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03068143

Contact: Guoyi Gao, Dr. +86-021-68383709

China, Shanghai
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Guoyi Gao, Dr.    +86-021-68383709   
Principal Investigator: Guoyi Gao, M.D., Ph.D.         
Sponsors and Collaborators
RenJi Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: RenJi Hospital Identifier: NCT03068143     History of Changes
Other Study ID Numbers: BT-201607
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Body Temperature Changes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Signs and Symptoms