UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038727
Receipt number R000044151
Scientific Title Checked if trainee was possible to distinguish whether the larynx or the esophageal.
Date of disclosure of the study information 2019/11/29
Last modified on 2020/11/30 14:04:34

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

When the initial trainees were shown typical photos of the larynx with a vocal cord in the middle, they did not mistake the entrance to the esophagus and the larynx.

Acronym

Trainee and laryngeal discrimination test

Scientific Title

Checked if trainee was possible to distinguish whether the larynx or the esophageal.

Scientific Title:Acronym

Trainee and laryngeal discrimination outcomes

Region

Japan


Condition

Condition

none

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to clarify whether the trainee can recognize the larynx.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Exam correct answer rate

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

On the first day of training, train students to take tests using laryngeal photographs.
All 25 questions
Test time is about 15 minutes
Only one test

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Trainees who chose anesthesiology training

Key exclusion criteria

There were no examples to exclude at this time.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kaori
Middle name Kimura
Last name Kuroiwa

Organization

Nagano Red Cross Hospital

Division name

Department of Anesthesiology

Zip code

380-8582

Address

22-1 Wakasato, Nagano, Japan

TEL

026-226-4131

Email

anesthesi0hanz13@yahoo.co.jp


Public contact

Name of contact person

1st name Kaori
Middle name Kimura
Last name Kuroiwa

Organization

Nagano Red Cross Hospital

Division name

Department of Anesthesiology

Zip code

380-8582

Address

22-1 Wakasato, Nagano, Japan

TEL

026-226-4131

Homepage URL


Email

anesthesi0hanz13@yahoo.co.jp


Sponsor or person

Institute

Nagano Red Cross Hospital
Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Nagano Red Cross Hospital
Department of Anesthesiology

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagano Red Cross Hospital

Address

22-1 Wakasato, Nagano, Japan

Tel

026-226-4131

Email

anesthesi0hanz13@yahoo.co.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

2019 Year 11 Month 29 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

Terminated

Date of protocol fixation

2017 Year 07 Month 01 Day

Date of IRB

2019 Year 11 Month 28 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2022 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 29 Day

Last modified on

2020 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044151


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name