UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036800 |
|---|---|
| Receipt number | 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 | 2022/03/17 17:14:03 |
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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 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
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
jinul8282@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041930
