UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038589 |
|---|---|
| Receipt number | R000043976 |
| Scientific Title | Measurement of perioperative core body temperature change by using Moni-Patch body temperature monitoring system. |
| Date of disclosure of the study information | 2019/11/15 |
| Last modified on | 2019/11/21 10:50:43 |
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Basic information
Public title
Measurement of perioperative core body temperature change by using Moni-Patch body temperature monitoring system.
Acronym
Measurement of perioperative core body temperature by using Moni-Patch
Scientific Title
Measurement of perioperative core body temperature change by using Moni-Patch body temperature monitoring system.
Scientific Title:Acronym
Measurement of perioperative core body temperature by using Moni-Patch
Region
| Japan |
Condition
Condition
patients under general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check whether the core body temperature can be measured accurately.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of core body temperature during anesthetic management
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
general anesthesia cases scheduled over for 180 minutes.
non-cardiac surgery.
Key exclusion criteria
skin abnormality
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Yamakage |
Organization
Sapporo Medical University
Division name
Department of Anesthesiology
Zip code
0608543
Address
S1,W16, chu-ou-ku, Sapporo
TEL
011-611-2111
yamakage@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Tachibana |
Organization
Sapporo Medical University
Division name
Department of Anesthesiology
Zip code
0608543
Address
S1,W16, chu-ou-ku, Sapporo
TEL
011-611-2111
Homepage URL
tachibana@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Sapporo Medical University
Address
S1,W16, chu-ou-ku, Sapporo
Tel
011-611-2111
tachibana@sapmed.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
札幌医科大学附属病院（北海道）、滝川市立病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Anesthesia is introduced by attaching Moni-Patch thermometer to the neck and lower clavicle. After induction of general anesthesia, an esophageal temperature probe is inserted protectively and measured as core body temperature. We continuously record the numerical values obtained from both Moni-Patch locations and the esophageal temperature probe and add a statistical analysis.
Management information
Registered date
| 2019 | Year | 11 | Month | 14 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043976
