UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019026 |
|---|---|
| Receipt number | R000022005 |
| Scientific Title | Evaluation of a newly developed non-invasive core temperature monitoring system "Temple Touch PRO"TM in the perioperative period |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2019/05/23 16:57:33 |
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Basic information
Public title
Evaluation of a newly developed non-invasive core temperature monitoring system "Temple Touch PRO"TM in the perioperative period
Acronym
monitoring of deep body temperature
Scientific Title
Evaluation of a newly developed non-invasive core temperature monitoring system "Temple Touch PRO"TM in the perioperative period
Scientific Title:Acronym
monitoring of deep body temperature
Region
| Japan |
Condition
Condition
general anesthesia patients
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, the equipment used for deep temperature monitoring has been developed(Non-invasive core temperature monitoring system "Temple Touch Pro"). We therefore evaluate this monitor in comparison with esophageal, tympanic and pulmonary artery temperature during general anesthesia even in Japanese patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of a newly developed monitoring system of deep body temperature "Temple Touch Pro" in comparison with other temperatures.
Key secondary outcomes
Observation of adverse events during using "Temple Touch Pro"
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
| 19 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases under general anesthesia
Key exclusion criteria
Forehead and face skin abnomarlity
Cases of esophageal lesion
Target sample size
30
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
minami 1 jo, nishi 16 chou-me, chuuou-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
minami 1 jo, nishi 16 chou-me, chuuou-ku, Sapporo
TEL
011-611-2111
Homepage URL
tachibana@sapmed.ac.jp
Sponsor or person
Institute
Department of Anesthesiology,Sapporo Medical University,School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology,Sapporo Medical 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
Sapporo Medical University
Address
minami 1 jo, nishi 16 chou-me, chuuou-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)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 15 | 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 | 09 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
In casese of non-cardicac operations,after induction of general anesthesia,we set non-invasive core temperature monitoring system "Temple Touch PRO" on face besides esophageal and tympanic temperature monitors.In casese of cardicac operations,after induction of general anesthesia,we set non-invasive core temperature monitoring system "Temple Touch PRO" on face besides esophageal,tympanic and pulmonary artery temperature monitors.
The temperature data are collected and statistically analyzed.
Management information
Registered date
| 2015 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022005
