UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036643 |
|---|---|
| Receipt number | R000031180 |
| Scientific Title | Evaluation of utility of trachea intubation education using Macintosh type video laryngoscope |
| Date of disclosure of the study information | 2019/05/03 |
| Last modified on | 2024/04/26 12:15:13 |
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Basic information
Public title
Evaluation of utility of trachea intubation education using Macintosh type video laryngoscope
Acronym
Evaluation of utility of trachea intubation education using Macintosh type video laryngoscope
Scientific Title
Evaluation of utility of trachea intubation education using Macintosh type video laryngoscope
Scientific Title:Acronym
Evaluation of utility of trachea intubation education using Macintosh type video laryngoscope
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a Macintosh-type video laryngoscope for intubation education for the first year of the resident during anesthesia department rotation, compared to a traditional laryngoscope educated only with a laryngoscope after training We will examine prospectively how much tracheal intubation technique is maintained after a certain period of time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intubation time
Intubation success rate
Key secondary outcomes
Intubation success rate.
Evaluation of degree of laryngeal development by POGO scale.
Tooth damage frequency.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Video laryngoscope
Interventions/Control_2
Macintosh-type laryngoscope
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
This study included first-year residents who completed a two-month rotation at our Department of Anesthesiology.
Key exclusion criteria
Exclusion criteria are when the consent for study participation was not obtained.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Yamamoto |
Organization
The Jikei University Kashiwa Hospital
Division name
Anesthesiology
Zip code
277-8567
Address
163-1 Kashiwasita, Kasiwa city
TEL
04-7164-1111
yuyy0206@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Yamamoto |
Organization
The Jikei University Kashiwa Hospital
Division name
Anesthesiology
Zip code
277-8567
Address
163-1 Kashiwasita, Kasiwa city
TEL
04-7164-1111
Homepage URL
yuyy0206@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
The Jikei University Kashiwa Hospital
Address
163-1 Kashiwasita, Kasiwa city
Tel
04-7164-1111
yuyy0206@jikei.ac.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
| 2019 | Year | 05 | Month | 03 | Day |
Related information
URL releasing protocol
https://doi.org/10.1177/03000605231206313
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1177/03000605231206313
Number of participants that the trial has enrolled
46
Results
Forty-six residents participated in this study and were assigned to the ML group (n = 23) or the MML group (n = 23). There were no significant differences between the sex, age and the number of endotracheal intubation procedures performed between the two groups. The time required for intubation was significantly shorter in the MML group compared with the ML group. The POGO scores did not show any significant differences between the two groups.
Results date posted
| 2024 | Year | 04 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 10 | Month | 17 | Day |
Baseline Characteristics
This randomized controlled study included first-year residents who started a 2-month rotation at the Department of Anaesthesiology, The Jikei University School of Medicine, Kashiwa Hospital, Chiba, Japan between May 2019 and March 2020.
Participant flow
This was a cluster randomized control trial because each group consisted of two to four residents who rotated every 2 months. Randomization was performed with a balanced randomization schedule and a predefined random number table.
Adverse events
None
Outcome measures
The primary outcome was a retention of endotracheal intubation skills evaluated as endotracheal intubation time.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: prospective observational study
Recruitment of target people: First year of resident
Recruitment period: June 2014-March 2017
Management information
Registered date
| 2019 | Year | 05 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031180
