UMIN-CTR Clinical Trial

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 success rate
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	30
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	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 08 Month 01 Day
Date of closure to data entry	2019 Year 08 Month 01 Day
Date trial data considered complete	2019 Year 08 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 20 Day
Last modified on	2022 Year 03 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041930