UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020625
Receipt number R000023805
Scientific Title Use of the new supraglottic device Ambu AuraGain in clinical settings
Date of disclosure of the study information 2016/01/19
Last modified on 2016/02/15 19:00:38

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Basic information

Public title

Use of the new supraglottic device Ambu AuraGain in clinical settings

Acronym

Use of the AuraGain in clinical settings

Scientific Title

Use of the new supraglottic device Ambu AuraGain in clinical settings

Scientific Title:Acronym

Use of the AuraGain in clinical settings

Region

Japan


Condition

Condition

the cases inserted the new supraglottic device Ambu AuraGain

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

a use investigation of the AuraGain

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the number of insertion

Key secondary outcomes



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

the cases inserted the AuraGain

Key exclusion criteria

the cases not inserted the AuraGain

Target sample size



Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironobu Ueshimaironobu

Organization

Showa University Hospital

Division name

Anesthesiology

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo Japan

TEL

03-3784-8575

Email

ueshimhi@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironobu Ueshima

Organization

Showa University Hospital

Division name

Anesthesiology

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan-ku

TEL

03-3784-8575

Homepage URL


Email

ueshimhi@yahoo.co.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


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

2016 Year 01 Month 19 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


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

2016 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 19 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

the cases inserted the AuraGain November 2015 to December 2015
Patient data was collected, including age, gender, body mass index, American society of Anesthesiologist classification, Mallampati classification, size of the AuraGain, the number of insertion and the size of gastric tube inserted after the insertion of AuraGain.


Management information

Registered date

2016 Year 01 Month 19 Day

Last modified on

2016 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023805


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name