UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034014
Receipt number R000038637
Scientific Title Comparison of video laryngoscope AWS and McGrath MAC by novice laryngoscopists: A Randomized Crossover Manikin Study
Date of disclosure of the study information 2018/09/15
Last modified on 2023/03/08 09:46:29

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Basic information

Public title

Comparison of video laryngoscope AWS and McGrath MAC by novice laryngoscopists: A Randomized Crossover Manikin Study

Acronym

Tanabata Study

Scientific Title

Comparison of video laryngoscope AWS and McGrath MAC by novice laryngoscopists: A Randomized Crossover Manikin Study

Scientific Title:Acronym

Tanabata Study

Region

Japan


Condition

Condition

Cardiopulmonary arrest

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of video laryngoscope

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Success rate of intubation in 120 seconds. Successful tracheal intubation was evaluated as follows: the tracheal tube passed through the vocal cords and was placed in the trachea, allowing visual confirmation by the investigator.

Key secondary outcomes

Intubation time: The time taken from insertion of the blade between the teeth until the tracheal tube was placed in the trachea.
Dental trauma: The time the blade made contact with the teeth during intubation.
Laryngeal open: Laryngeal open was evaluted by percentage of glottic opening (POGO) score.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Air Way Scope was used intubation.

Interventions/Control_2

McGRATH MAC was used intubation.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Residents of Kindai University Hospital, Facility of Medicine, who completed Anesthesiology.

Key exclusion criteria

Exclusion criteria were those who could not perform elaborate manual operations or who did not give their consent to participate in the study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Nakao

Organization

Kindai University Faculty of Medicine

Division name

Anesthesiology

Zip code


Address

377-2 Ohonohigasi Osakasayama Osaka

TEL

072-366-0221

Email

nakaos@med.kindai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruyuki Yuasa

Organization

Kindai University Faculty of Medicine

Division name

Anesthesiology

Zip code


Address

377-2 Ohonohigasi Osakasayama Osaka

TEL

072-366-0221

Homepage URL


Email

h-yuasa@med.kindai.ac.jp


Sponsor or person

Institute

Kindai University Faculty of Medicine
Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Kindai University Faculty of Medicine
Department of Anesthesiology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

近畿大学医学部附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 15 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

2018 Year 07 Month 07 Day

Date of IRB

2018 Year 08 Month 20 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry

2019 Year 07 Month 31 Day

Date trial data considered complete

2019 Year 08 Month 31 Day

Date analysis concluded

2019 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 09 Month 03 Day

Last modified on

2023 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038637


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name