UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040269 |
|---|---|
| Receipt number | R000045939 |
| Scientific Title | Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequin study |
| Date of disclosure of the study information | 2020/04/30 |
| Last modified on | 2021/07/17 09:55:17 |
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Basic information
Public title
Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequin study
Acronym
Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequin study
Scientific Title
Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequin study
Scientific Title:Acronym
Comparison of laryngoscopes under the aerosol box for tracheal intubation: a randomized crossover mannequinnstudy
Region
| Japan |
Condition
Condition
mannequin
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the time taken for tracheal intubation under the aerosol box for tracheal intubation using three laryngoscopes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time taken for tracheal intubation
Key secondary outcomes
Success rate of tracheal intubation, subjective difficulty score, incidence of esophageal intubation, Cormack-Lehane score
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Macintosh direct laryngoscope
Interventions/Control_2
i-view video laryngoscope
Interventions/Control_3
C-MAC video laryngoscope
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Anesthesiologists with at least 2 years of experience in airway management
Key exclusion criteria
Those who did not get consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakanishi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi prefecture
TEL
+81-52-853-8281
nakanishi.anest@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakanishi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
467-8601
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi prefecture
TEL
+81-52-853-8281
Homepage URL
nakanishi.anest@gmail.com
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences, Department of Anesthesiology and Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences, Department of Anesthesiology and Intensive Care 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
Nagoya City University Hospital, Clinical Research Management Center
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aichi prefecture
Tel
+81-52-851-5511
clinical_research@med.nagoya-cu.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
| 2020 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8234758/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8234758/
Number of participants that the trial has enrolled
37
Results
There was no significant difference in the intubation time: 30 [26-32] s for Macintosh, 29 [26-32] s for i-view, and 29 [25-31] s for C-MAC (P=0.247). The success rate was 95-100%, without a significant difference (P=0.135). The i-view and C-MAC exhibited superior Cormack-Lehane grades and lower subjective difficulty scale scores than the Macintosh; however, there were no differences between the i-view and C-MAC.
Results date posted
| 2021 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 26 | Day |
Baseline Characteristics
We recruited 37 medical personnel with > 2 years of dedicated anesthesia experience from five hospitals.
Participant flow
We enrolled 37 personnel; all their records were incorporated into the final analysis.
Adverse events
None.
Outcome measures
The primary outcome was the
intubation time. The secondary outcome included the success rate, Cormack-Lehane grade, and subjective difficulty scale score.
Plan to share IPD
We will share individual deidentified participant data immediately following publication.
IPD sharing Plan description
We will share individual deidentified participant data including outcome of the study (intubation time, whether success or failure, Cormack-Lehane grade, and numeric rating scale of subjective difficulty scale).
We will share data immediately after publication, with no set end date.
We will provide access to data for any purpose when a researcher makes a reasonable request for data.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 11 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 11 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 29 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045939
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