UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056008 |
|---|---|
| Receipt number | R000063989 |
| Scientific Title | Whether the AceScopeTM program revision facilitate tracheal intubation time or the success rate in novice physicians in manikin study. |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/11/06 15:23:16 |
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Basic information
Public title
Whether dose the AceScopeTM program revision facilitate tracheal intubation time or the success rate in novice physicians in manikin study?
Acronym
Simulation study using the AceScopeTM before and after program revision in novice physicians.
Scientific Title
Whether the AceScopeTM program revision facilitate tracheal intubation time or the success rate in novice physicians in manikin study.
Scientific Title:Acronym
Comparative study of AceScopeTM before and after program revision
Region
| Japan |
Condition
Condition
Difficult airway management simulator
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
AceScopeTM improved its monitor view through the recent internal program revision compared with the product launch. However, whether the revision accelerates the endotracheal tube intubation skill is unknown. Therefore, we aimed to investigate in the manikin study whether the AceScopeTM program revision facilitates tracheal intubation time as well as the success rate in novice physicians.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Novice physicians perform tracheal intubation on a manikin using the AceScopTM video laryngoscope before and after the program revision, evaluating the success rate and intubation time.
Key secondary outcomes
We also assess frequency of dental injury, laryngeal view, and physician NRS of easiness.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Novice physicians without endotracheal intubation experience
Key exclusion criteria
Endotracheal intubation experience
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kobayashi |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Anesthesiology
Zip code
433-8558
Address
Mikatahara-cho 3453, Chuo-ku, Hamamatsu City, Shizuoka Prefecture, Japan
TEL
053-436-1251
mym96472@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kobayashi |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Anesthesiology
Zip code
433-8558
Address
Mikatahara-cho 3453, Chuo-ku, Hamamatsu City, Shizuoka Prefecture, Japan
TEL
053-436-1251
Homepage URL
mym96472@gmail.com
Sponsor or person
Institute
Seirei Mikatahara General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Seirei Mikatahara General Hospital
Address
Mikatahara-cho 3453, Chuo-ku, Hamamatsu City, Shizuoka Prefecture, Japan
Tel
053-436-1251
mk-chiken@sis.seirei.or.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
| 2024 | Year | 11 | Month | 01 | 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
31
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
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conducted a cohort study, enrolling 31 first-year hospital residents as novice physician who performed clinical training at our hospital in 2023 and 2024. They were assigned to the pre- (n=15) and post-program revision (n=16) groups. Each physician intubated an endotracheal tube to a manikin with the AceScopeTM video laryngoscope twice subsequently. We assessed the intubation success rate, intubation time, frequency of dental injury, laryngeal view, and physician NRS of easiness.
Management information
Registered date
| 2024 | Year | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063989
