UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017108 |
|---|---|
| Receipt number | R000019845 |
| Scientific Title | Study of Heat receipts and disbursements during general anesthesia by heat flow meter |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2021/04/19 11:40:37 |
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Basic information
Public title
Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Acronym
Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Scientific Title
Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Scientific Title:Acronym
Study of Heat receipts and disbursements during general anesthesia by heat flow meter
Region
| Japan |
Condition
Condition
patient for general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a heat flow meter, consider the temperature and heat teller during general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body temperature and heat flow value of body surface during general anesthesia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia
Key exclusion criteria
Patients who did not consent to the person or guardian
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mikito |
| Middle name | |
| Last name | Kawamata |
Organization
Shinshu University school of medicine
Division name
The department of anesthesiology and resuscitology
Zip code
3908621
Address
3-1-1 Asahi Matsumoto city Nagano
TEL
0262-37-2670
masui@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Murakami |
Organization
Shinshu University school of medicine
Division name
The department of anesthesiology and resuscitology
Zip code
3908621
Address
3-1-1 Asahi Matsumoto city Nagano
TEL
0262-37-2670
Homepage URL
torum@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University school of medicine The department of anesthesiology and resuscitology
Address
3-1-1 Asahi Matsumoto city Nagano
Tel
0262-37-2670
torum@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://shinshu.bvits.com/rinri/Apply/show.aspx?TYPE=0&ID=1138
Publication of results
Unpublished
Result
URL related to results and publications
https://shinshu.bvits.com/rinri/Apply/show.aspx?TYPE=2&ID=3620
Number of participants that the trial has enrolled
7
Results
We examined heat dissipation during surgery. As a result, it was found that the intraoperative heat discharge was almost constant. By site, heat discharge from the forearm was high. There was no correlation between heat release and blood pressure or skin temperature, but the variation of heat release tended to be higher in the forearm. A report on this study was presented at the 2016 Annual Meeting of the Japanese Society of Anesthesiologists.
Results date posted
| 2021 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing surgery under general anesthesia who have given their consent.
Participant flow
After entering the operating room and before induction of anesthesia, the heat flow sensor is attached to the patient's body surface using skin tape. Then, general anesthesia and surgery are performed as usual. The data from the sensor is imported into the analysis software at regular intervals. The sensor is removed at the end of the surgery.
Adverse events
none.
Outcome measures
Heat diffusion, blood pressure, and skin temperature by heat flux meter
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After entering operating room, a thermal flow sensor is stuck to patient's skin by using a tape before anesthetic introduction. the data is taken in software for analyses every regular interval .When measuring the indirect calorimetry, We use Carescape bedside monitor which metabolism monitor has been built (GE healthcare) and metabolic measurement module. Anesthesia and a monitoring are performed as usual.
Management information
Registered date
| 2015 | Year | 04 | Month | 11 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019845
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