UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016147 |
|---|---|
| Receipt number | R000018747 |
| Scientific Title | Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia. |
| Date of disclosure of the study information | 2015/01/08 |
| Last modified on | 2015/12/21 17:57:40 |
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Basic information
Public title
Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.
Acronym
Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.
Scientific Title
Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.
Scientific Title:Acronym
Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.
Region
| Japan |
Condition
Condition
pediatric patients considered suitable for general anesthesia.
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the accuracy,usability and safety of "CE-Thermo" newly developed for children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the newly developed thermometer "CE-thermo" in comparison with others.
Key secondary outcomes
Observation of adverse effects and complications caused by using "CE-Thermo".
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
| 4 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cases under general anesthesia,ASA-PS:1-2
Key exclusion criteria
emergent surgery,patients with congenital deformations of oral cavity and both ears
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamakage Michiaki |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1W16, chu-o-ku, Sapporo
TEL
011-611-2111
yamakage@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tachibana Shunsuke |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1W16, chu-o-ku, Sapporo
TEL
011-611-2111
Homepage URL
tachibana@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine,Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 21 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measure the tympanic temperature using CE-Thermo newly developed for children under general anesthesia.From these datas,we investigate the accuracy,usability and safety during using CE-Thermo in comparison with other thermometers.
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2015 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018747
