UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016147
Receipt number R000018747
Scientific Title Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.
Date of disclosure of the study information 2015/01/08
Last modified on 2015/12/21 17:57:40

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Basic information

Public title

Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.

Acronym

Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.

Scientific Title

Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.

Scientific Title:Acronym

Measurements of tympanic temperature using new CE-Thermo under pediatric anesthesia.

Region

Japan


Condition

Condition

pediatric patients considered suitable for general anesthesia.

Classification by specialty

Anesthesiology Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the accuracy,usability and safety of "CE-Thermo" newly developed for children.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of the newly developed thermometer "CE-thermo" in comparison with others.

Key secondary outcomes

Observation of adverse effects and complications caused by using "CE-Thermo".


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

4 years-old <=

Age-upper limit

12 years-old >=

Gender

Male and Female

Key inclusion criteria

cases under general anesthesia,ASA-PS:1-2

Key exclusion criteria

emergent surgery,patients with congenital deformations of oral cavity and both ears

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yamakage Michiaki

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

S1W16, chu-o-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 School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

S1W16, chu-o-ku, Sapporo

TEL

011-611-2111

Homepage URL


Email

tachibana@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine,Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

none

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


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



Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 08 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

Completed

Date of protocol fixation

2015 Year 01 Month 07 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 07 Day

Last follow-up date

2015 Year 12 Month 21 Day

Date of closure to data entry

2015 Year 12 Month 21 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

We measure the tympanic temperature using CE-Thermo newly developed for children under general anesthesia.From these datas,we investigate the accuracy,usability and safety during using CE-Thermo in comparison with other thermometers.


Management information

Registered date

2015 Year 01 Month 07 Day

Last modified on

2015 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name