UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039057
Receipt number 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 13:07:48

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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 or person

Institute

Sapporo Medical University

Institute

Department

Personal name



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

Value
https://center6.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