Postoperative Temperature Monitoring In Brain Trauma (PTMIBT)

February 24, 2017 updated by: RenJi Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Principal Investigator:
          • Guoyi Gao, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the patients with brain trauma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

February 1, 2018

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (ACTUAL)

March 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT-201607

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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