UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040381
Receipt number R000046083
Scientific Title Comparison of videolaryngoscopes with the Macintosh laryngoscope in manikins by novice personnel
Date of disclosure of the study information 2020/05/12
Last modified on 2021/06/21 09:51:57

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Basic information

Public title

Comparison of videolaryngoscopes
with the Macintosh laryngoscope
in manikins by novice personnel

Acronym

Comparison of videolaryngoscopes
with the Macintosh laryngoscope
in manikins by novice personnel

Scientific Title

Comparison of videolaryngoscopes
with the Macintosh laryngoscope
in manikins by novice personnel

Scientific Title:Acronym

Comparison of videolaryngoscopes
with the Macintosh laryngoscope
in manikins by novice personnel

Region

Japan


Condition

Condition

in a manikin study

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For physicians who rarely perform tracheal intubation, investigate whether there are easy-to-use videolaryngoscopes among several types of videolaryngoscopes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intubation time

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Comparison test of intubation time when using Airtrac TM, McGrath TM, King Vision TM, Airway Scope TM, Nishikawa blade video laryngoscope and Macintosh type laryngoscope

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

24 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Doctors who had done less than 12 tracheal intubations last year

Key exclusion criteria

Without concent

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Junko
Middle name
Last name Ajimi

Organization

Hachioji-Hospital, Tokai University of School of Medicine

Division name

Department of Anesthesiology

Zip code

1920032

Address

1838 Ishikiawamachi, Hachioji, Tokyo, Japan

TEL

042-639-1111

Email

ajimi@is.icc.u-tokai.ac.jp


Public contact

Name of contact person

1st name Junko
Middle name
Last name Ajimi

Organization

Hachioji-Hospital, Tokai University of School of Medicine

Division name

Department of Anesthesiology

Zip code

1920032

Address

1838 Ishikiawamachi, Hachioji, Tokyo, Japan

TEL

042-639-1111

Homepage URL


Email

ajimi@is.icc.u-tokai.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Hachioji-Hospital, Tokai University of School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Hachioji-Hospital, Tokai University of School of Medicine

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

Clinical Research Administration Office ,Tokai UniversityHospital

Address

143 Shimokasuya, Isehara, Kanagawa

Tel

0463-93-1121

Email

tokai-rinsho@ml.tokai-u.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

2020 Year 05 Month 12 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

Enrolling by invitation

Date of protocol fixation

2020 Year 04 Month 13 Day

Date of IRB

2020 Year 04 Month 17 Day

Anticipated trial start date

2020 Year 05 Month 13 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 05 Month 12 Day

Last modified on

2021 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name