UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049117
Receipt number R000055923
Scientific Title Effective visualization of laryngoscopy and tracheal intubation, using McGRATH with guiding mark on the screen : A Manikin study for trainees
Date of disclosure of the study information 2022/10/05
Last modified on 2022/10/07 17:58:23

* 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

Effective visualization of laryngoscopy and tracheal intubation, using McGRATH with guiding mark on the screen : A Manikin study for trainees

Acronym

Effective visualization of laryngoscopy and tracheal intubation, using McGRATH with guiding mark on the screen : A Manikin study for trainees

Scientific Title

Effective visualization of laryngoscopy and tracheal intubation, using McGRATH with guiding mark on the screen : A Manikin study for trainees

Scientific Title:Acronym

Effective visualization of laryngoscopy and tracheal intubation, using McGRATH with guiding mark on the screen : A Manikin study for trainees

Region

Japan


Condition

Condition

Cardiopulmonary arrest

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the guiding mark on the screen of McGRATH (Videolaryngoscope) for the training of tracheal intubation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Requiring time for tracheal intubating procedure

Key secondary outcomes

1) Success rate of Tracheal intubating procedure
2) Incidence rate of teeth injury during the procedure
3) Effect for tracheal intubating procedure with Macintosh laryngoscope


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

McGRATH Videolaryngosocopy and tracheal intubation procedure, with guiding mark on the screen

Interventions/Control_2

McGRATH Videolaryngosocopy and tracheal intubation procedure, without guiding mark on the screen

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 or Medical students(4th or 5th grade), who undergo training Anesthesiology

Key exclusion criteria

Those who dose not consent to join the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Chihiro
Middle name
Last name Takamatsu

Organization

Kouhoukai Takagi Hospital

Division name

Anesthesiology

Zip code

831-0016

Address

141-11 Sakemi Okawa City, Fukuoka, Japan

TEL

0944870001

Email

takamatsu-c@kouhoukai.org


Public contact

Name of contact person

1st name Chihiro
Middle name
Last name Takamatsu

Organization

Kouhoukai Takagi Hospital

Division name

Anesthesiology

Zip code

831-0016

Address

141-11 Sakemi Okawa City, Fukuoka, Japan

TEL

0944870001

Homepage URL


Email

ctakamatsu@hotmail.com


Sponsor or person

Institute

Kouhoukai Takagi Hospital

Institute

Department

Personal name



Funding Source

Organization

Kouhoukai Takagi 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

Kouhoukai Takagi Hospital

Address

141-11 Sakemi Okawa City, Fukuoka, Japan

Tel

0944870001

Email

takamatsu-c@kouhoukai.org


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

2022 Year 10 Month 05 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

Open public recruiting

Date of protocol fixation

2022 Year 10 Month 04 Day

Date of IRB

2022 Year 10 Month 04 Day

Anticipated trial start date

2022 Year 10 Month 06 Day

Last follow-up date

2023 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

2022 Year 10 Month 04 Day

Last modified on

2022 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name