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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015586
Receipt No. R000018115
Scientific Title Evaluation of a newly developed monitor of deep body temperature in the perioperative period
Date of disclosure of the study information 2014/11/03
Last modified on 2015/08/03

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Basic information
Public title Evaluation of a newly developed monitor of deep body temperature in the perioperative period
Acronym monitoring of deep body temperature
Scientific Title Evaluation of a newly developed monitor of deep body temperature 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 this monitor in comparison with esophageal, tympanic and pulmonary artery temperature 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
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 skin abnomarlity
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamakage Michiaki
Organization Sapporo Medical University
Division name Anesthesiology
Zip code
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
Middle name
Last name Tachibana Shunsuke
Organization Sapporo Medical University
Division name Department of Anesthesiology
Zip code
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 03 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 Main results already published
Date of protocol fixation
2014 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 16 Day
Last follow-up date
Date of closure to data entry
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 motor on forehead besides esophageal and tympanic temperature monitoring.In casese of cardicac operations,after induction of general anesthesia,we set deep body teperature motor on forehead besides esophageal,tympanic and pulmonary artery temperature monitoring.
The data were statistically analyzed.

Management information
Registered date
2014 Year 11 Month 02 Day
Last modified on
2015 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018115

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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