UMIN-CTR Clinical Trial

Basic information
Public title	Agreement between neck and forehead temperatures measured by zero-heat-flux thermometry with esophageal temperature during anesthesia.
Acronym	Agreement between neck and forehead temperatures measured by zero-heat-flux thermometry with esophageal temperature during anesthesia.
Scientific Title	Agreement between neck and forehead temperatures measured by zero-heat-flux thermometry with esophageal temperature during anesthesia.
Scientific Title:Acronym	Agreement between neck and forehead temperatures measured by zero-heat-flux thermometry with esophageal temperature during anesthesia.
Region	Japan

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

Objectives
Narrative objectives1	Agreement between esophageal temperature, measured with a general-purpose thermistor-based probe, and neck temperature, measured by BHTMS.
Basic objectives2	Others
Basic objectives -Others	Agreement between neck and forehead temperatures, both measured using BHTMS.
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Agreement between esophageal temperature, measured with a general-purpose thermistor-based probe, and neck temperature, measured by BHTMS.
Key secondary outcomes	Agreement between neck and forehead temperatures, both measured using BHTMS.

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	20-80 years old, noncardiac surgery under general anesthesia, temperature monitoring over 120 min, ASA-PS1-3, supine position case.
Key exclusion criteria	not meeting inclusion criteria, esophageal lesions and skin abnormalities, urgent surgery, accidental hypothermia.
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	060-8543
Address	S1,W16, chu-ou-ku, Sapporo
TEL	011-611-2111
Email	yamakage@sapmed.ac.jp

Public contact
Name of contact person	1st name Michiaki Middle name Last name Yamakage
Organization	Sapporo Medical University
Division name	Department of Anesthesiology
Zip code	060-8543
Address	S1,W16, chu-ou-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	yamakage@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	Sapporo Medical University
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	札幌医科大学付属病院

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 06 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	30
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	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 09 Month 13 Day
Anticipated trial start date	2020 Year 01 Month 06 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 03 Month 30 Day
Date analysis concluded	2020 Year 05 Month 30 Day

Other
Other related information	The purpose of this trial is to assess the agreement between core temperatures measured from the neck by zero-heat-flux thermometry with those measured at the distal esophagus. The secondary purpose is to compare the agreement between neck and forehead temperatures measured by zero-heat-flux thermometry.

Management information
Registered date	2020 Year 01 Month 06 Day
Last modified on	2020 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044543