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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036800
Receipt No. R000041930
Scientific Title Comparison of tracheal intubation with a new video intubation stylet using smartphone display and McGrath, for novice personnel: a manikin study
Date of disclosure of the study information 2019/05/21
Last modified on 2019/07/11

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Basic information
Public title Comparison of tracheal intubation with a new video intubation stylet using smartphone display and McGrath, for novice personnel: a manikin study
Acronym Comparison of tracheal intubation with a new video intubation stylet using smartphone display and McGrath, for novice personnel: a manikin study
Scientific Title Comparison of tracheal intubation with a new video intubation stylet using smartphone display and McGrath, for novice personnel: a manikin study
Scientific Title:Acronym Comparison of tracheal intubation with a new video intubation stylet using smartphone display and McGrath, for novice personnel: a manikin study
Region
Asia(except Japan)

Condition
Condition Intubation device
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We would like to identify intubation devices that are more favorable to novice personnel between the video intubation stylet and video laryngoscope
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 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 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 All subjects were educated about the video intubation devices (Mcgrath and AVS) for 5 mintues. AVS is a video intubation stylet which can be connected to mobile devices (smartphone or tablet pc). Performer can see the camera view at the end of the stylet through the mobile devices. After the education, participants perform 5 intubation attempts with AVS in a specifically designed intubation manikin, Laerdal Airway Management Trainer (normal airway scenario).
Interventions/Control_2 Mcgrath is a video laryngoscope with a display monitor through which a performer can see the camera view at the blade tip. After the education, participants perform 5 intubation attempts with Mcgrath in the manikin (normal airway scenario).
Interventions/Control_3 Participants perform 5 intubation attempts with AVS in the manikin with a cervical collar interfering neck extension (difficult airway scenario).
Interventions/Control_4 Participants perform 5 intubation attempts with Mcgrath in the manikin with a cervical collar interfering neck extension (difficult airway scenario).
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
60 years-old >=
Gender Male and Female
Key inclusion criteria - Medical doctor
- Working in Seoul National University Bundang Hospital
- Clinical experience of intubation < 4 times
Key exclusion criteria - Clinical experience of intubation > 3 times
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Jin-Hee
Middle name
Last name Kim
Organization Seoul National University Bundang Hospital
Division name Department of Anesthesiology and Pain Medicine
Zip code 13620
Address 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea
TEL 82-31-787-7499
Email anesing1@snu.ac.kr

Public contact
Name of contact person
1st name Jin-Woo
Middle name
Last name Park
Organization Seoul National University Bundang Hospital
Division name Department of Anesthesiology and Pain Medicine
Zip code 13620
Address 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea
TEL 82-31-787-7509
Homepage URL
Email jinul8282@gmail.com

Sponsor
Institute Seoul National University Bundang Hospital
Institute
Department

Funding Source
Organization Seoul National University Bundang Hospital
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Republic of Korea

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Seoul National University Bundang Hospital
Address 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
Tel 82-31-787-8801
Email snubhirb@gmail.com

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 05 Month 21 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
2019 Year 05 Month 20 Day
Date of IRB
2019 Year 04 Month 18 Day
Anticipated trial start date
2019 Year 06 Month 13 Day
Last follow-up date
2019 Year 07 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 20 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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