UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034014 |
|---|---|
| Receipt number | R000038637 |
| Scientific Title | Comparison of video laryngoscope AWS and McGrath MAC by novice laryngoscopists: A Randomized Crossover Manikin Study |
| Date of disclosure of the study information | 2018/09/15 |
| Last modified on | 2023/03/08 09:46:29 |
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Basic information
Public title
Comparison of video laryngoscope AWS and McGrath MAC by novice laryngoscopists: A Randomized Crossover Manikin Study
Acronym
Tanabata Study
Scientific Title
Comparison of video laryngoscope AWS and McGrath MAC by novice laryngoscopists: A Randomized Crossover Manikin Study
Scientific Title:Acronym
Tanabata Study
Region
| Japan |
Condition
Condition
Cardiopulmonary arrest
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of video laryngoscope
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of intubation in 120 seconds. Successful tracheal intubation was evaluated as follows: the tracheal tube passed through the vocal cords and was placed in the trachea, allowing visual confirmation by the investigator.
Key secondary outcomes
Intubation time: The time taken from insertion of the blade between the teeth until the tracheal tube was placed in the trachea.
Dental trauma: The time the blade made contact with the teeth during intubation.
Laryngeal open: Laryngeal open was evaluted by percentage of glottic opening (POGO) score.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Air Way Scope was used intubation.
Interventions/Control_2
McGRATH MAC was used intubation.
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 of Kindai University Hospital, Facility of Medicine, who completed Anesthesiology.
Key exclusion criteria
Exclusion criteria were those who could not perform elaborate manual operations or who did not give their consent to participate in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Nakao |
Organization
Kindai University Faculty of Medicine
Division name
Anesthesiology
Zip code
Address
377-2 Ohonohigasi Osakasayama Osaka
TEL
072-366-0221
nakaos@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruyuki Yuasa |
Organization
Kindai University Faculty of Medicine
Division name
Anesthesiology
Zip code
Address
377-2 Ohonohigasi Osakasayama Osaka
TEL
072-366-0221
Homepage URL
h-yuasa@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Kindai University Faculty of Medicine
Department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
近畿大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038637
