Brain Injuries, TraumaticPTMIBTNCT03068143
Postoperative Temperature Monitoring In Brain Trauma
An observational study of Brain Injuries, Traumatic and Body Temperature Changes, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Injuries, Traumatic, Body Temperature Changes
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Mar 2017to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients with brain trauma
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Guoyi Gao, Dr., +86-021-68383709, guoyigao@gmail.com
Guoyi Gao, M.D., Ph.D.
About this study
Official title: 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.
- Medical subject headings
- Brain Injuries, Traumatic, Body Temperature Changes
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Brain Temperature
Measured: Change from Baseline Brain Temperature at 1 week
Change of Axillary Temperature
Measured: Change from Baseline Axillary Temperature at 1 week
Change of Rectal Temperature
Measured: Change from Baseline Rectal Temperature at 1 week
Change of Bladder Temperature
Measured: Change from Baseline Bladder Temperature at 1 week
Glasgow Outcome Scale
An objective assessment of the recovery of patients with brain trauma
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068143
- Sponsor's protocol ID
- BT-201607
- Acronym
- PTMIBT
- Status last verified
- Feb 2017
- First submitted
- 21 Feb 2017
- Last updated
- 1 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 4311724Mellergard P, Nordstrom CH. Intracerebral temperature in neurosurgical patients. Neurosurgery. 1991 May;28(5):709-13.
PubMed 1876249Mellergard 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.
PubMed 15815447Hirashima 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.
PubMed 9647313Camboni 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.
PubMed 18658167Henker 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.
PubMed 9588552Weng 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.
PubMed 30215286
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Muti-centre Prospective Observational Study on Postoperative Temperature Monitoring In Patients With Brain Trauma
- ClinicalTrials.gov ID
- NCT03068143
- Acronym / sponsor ID
- PTMIBT / BT-201607
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients with brain trauma
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Brain Temperature
Time frame: Change from Baseline Brain Temperature at 1 week
Change of Axillary Temperature
Time frame: Change from Baseline Axillary Temperature at 1 week
Change of Rectal Temperature
Time frame: Change from Baseline Rectal Temperature at 1 week
Change of Bladder Temperature
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Background: PubMed 4311724Hayward 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.
- Background: PubMed 1876249Mellergard P, Nordstrom CH. Intracerebral temperature in neurosurgical patients. Neurosurgery. 1991 May;28(5):709-13.
- Background: PubMed 15815447Mellergard 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.
- Background: PubMed 9647313Hirashima 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.
- Background: PubMed 18658167Camboni 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.
- Background: PubMed 9588552Henker 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.
- Derived from this study: PubMed 30215286Weng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic and Body Temperature Changes, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoyi Gao, Dr. (+86-021-68383709, guoyigao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Brain Temperature (time frame: Change from Baseline Brain Temperature at 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068143, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.