UMIN-CTR Clinical Trial

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
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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
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	0608543
Address	S1,W16, chu-ou-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	tachibana@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

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
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）、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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043976