UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of a newly developed monitor of deep body temperature other than the forehead in the perioperative period
Acronym	monitoring of deep body temperature
Scientific Title	Evaluation of a newly developed monitor of deep body temperature other than the forehead in the perioperative period
Scientific Title:Acronym	monitoring of deep body temperature
Region	Japan

Condition
Condition	general anesthesia patients
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recently, equipment used for deep temperature monitoring has been improved with release of a new instrument (Spot OnTM; 3M, St. Paul, MN). We therefore evaluated the temperature data obtained from other than the forehead in comparison with esophageal, tympanic and pulmonary artery temperatures during general anesthesia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of a newly developed monitor of deep body temperature in comparison with others.
Key secondary outcomes	Observation of adverse events during using deep tempreture monitor.

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
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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 skin abnomarlity
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	0600543
Address	minami 1 jo, nishi 16 chou-me, chuuou-ku, Sapporo
TEL	011-611-2111
Email	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	0600543
Address	minami 1 jo, nishi 16 chou-me, chuuou-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	tachibana@sapmed.ac.jp

Sponsor
Institute	Department of Anesthesiology,Sapporo Medical University,School of Medicine
Institute
Department

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 IRB
Address	minami 1 jo, nishi 16 chou-me, chuuou-ku, Sapporo
Tel	011-611-2111
Email	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),Sapporo Medical University(Hokkaido)

Other administrative information
Date of disclosure of the study information	2015 Year 03 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
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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 14 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 15 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

In casese of non cardicac operations,after induction of general anesthesia,we set deep body teperature monitor except forehead (ex.neck or chest) and measure esophageal,tympanic temperature. In casese of cardicac operations,after induction of general anesthesia,we set deep body teperature monitor except forehead (ex.neck or chest) and measure esophageal,tympanic,pulmonary artery temperature. The temperature data were collected and statistically analyzed.

Management information
Registered date	2015 Year 03 Month 15 Day
Last modified on	2020 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019501

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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