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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039057
Receipt No. R000044543
Scientific Title Agreement between neck and forehead temperatures measured by zero-heat-flux thermometry with esophageal temperature during anesthesia.
Date of disclosure of the study information 2020/01/06
Last modified on 2020/05/30

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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

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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