UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033482
Receipt number R000038183
Scientific Title Accuracy for continuous measurement type ear thermometer
Date of disclosure of the study information 2018/07/23
Last modified on 2019/07/24 11:09:14

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Basic information

Public title

Accuracy for continuous measurement type ear thermometer

Acronym

Accuracy for continuous measurement type ear thermometer

Scientific Title

Accuracy for continuous measurement type ear thermometer

Scientific Title:Acronym

Accuracy for continuous measurement type ear thermometer

Region

Japan


Condition

Condition

cases under general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Accuracy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tympanic membrane temperature

Key secondary outcomes

Rectal temperature


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases under general anesthesia

Key exclusion criteria

Non cases under general anesthesia

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hironobu
Middle name
Last name Ueshima

Organization

Showa university hospital

Division name

Anesthesiology

Zip code

142-8666

Address

1-5-8, hatanodai, shinagawa-ku, tokyo

TEL

03-3784-8575

Email

ueshimhi@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Hironobu
Middle name
Last name Ueshima

Organization

Showa university hospital

Division name

Anesthesiology

Zip code

142-8666

Address

1-5-8, hatanodai, shinagawa-ku, tokyo,

TEL

03-3784-8575

Homepage URL


Email

ueshimhi@med.showa-u.ac.jp


Sponsor or person

Institute

Showa university hospital

Institute

Department

Personal name



Funding Source

Organization

Showa university hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Showa university hospital

Address

1-5-8, hatanodai, shinagawa-ku, tokyo

Tel

03-3784-8575

Email

ueshimhi@med.showa-u.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



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


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

2017 Year 07 Month 23 Day

Date of IRB

2017 Year 07 Month 23 Day

Anticipated trial start date

2017 Year 07 Month 23 Day

Last follow-up date

2021 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The difference between Rectal temperature and tympanic membrane temperature from january and june, 2018.


Management information

Registered date

2018 Year 07 Month 23 Day

Last modified on

2019 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name