UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050394 |
|---|---|
| Receipt number | R000057382 |
| Scientific Title | A randomized crossover comparison study of tracheal intubation using video laryngoscopes, AceScope, McGrath and Airwayscope for novice learners on manikin simulation |
| Date of disclosure of the study information | 2023/02/21 |
| Last modified on | 2023/02/21 13:02:00 |
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Basic information
Public title
A randomized crossover comparison study of tracheal intubation using video laryngoscopes, AceScope, McGrath and Airwayscope for novice learners on manikin simulation
Acronym
Randomized crossover study comparing video laryngoscopes, AceScope, McGrath and Airwayscope for tracheal intubation in novice learners using manikin simulation
Scientific Title
A randomized crossover comparison study of tracheal intubation using video laryngoscopes, AceScope, McGrath and Airwayscope for novice learners on manikin simulation
Scientific Title:Acronym
Randomized crossover study comparing video laryngoscopes, AceScope, McGrath and Airwayscope for tracheal intubation in novice learners using manikin simulation
Region
| Japan |
Condition
Condition
Adult patient under general anesthesia undergoing scheduled surgery
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare tracheal intubation time and ease of use among three video laryngoscopes, AceScope, McGrath, and AirwayScope, for novice learners on manikin simulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of tracheal intubation
Key secondary outcomes
Intubation time
Number of times performed
Failure rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Use of AceScope video laryngoscopes for tracheal intubation into mannequins
Interventions/Control_2
Use of Mcgrath video laryngoscopes for tracheal intubation into mannequins
Interventions/Control_3
Use of AirwayScope video laryngoscopes for tracheal intubation into mannequins
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults who have never performed tracheal intubation on a patient or manikin
Key exclusion criteria
Adults who have performed tracheal intubation on patients or mannequins
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Musashi |
| Middle name | |
| Last name | Yahagi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
3170077
Address
Hitachi Jounanchou 2-1-1
TEL
0294231111
musasum0710@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Musashi |
| Middle name | |
| Last name | Yahagi |
Organization
Hitachi general hospital
Division name
Anesthesiology
Zip code
3170077
Address
Hitachi Jounanchou 2-1-1
TEL
0294231111
Homepage URL
musasum0710@yahoo.co.jp
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi genetal Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hitachi general hospital
Address
Hitachi Jounanchou 2-1-1
Tel
0294231111
musasum0710@yahoo.co.jp
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
| 2023 | Year | 02 | 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
| 2023 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057382
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
