UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033456 |
|---|---|
| Receipt number | R000038150 |
| Scientific Title | A randomized comparison of the MultiViewScope handle with a stylet scope to the Miller blade direct laryngoscopy in manikins simulating normal and difficult pediatric airways |
| Date of disclosure of the study information | 2018/07/20 |
| Last modified on | 2020/09/16 17:47:03 |
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Basic information
Public title
A randomized comparison of the MultiViewScope handle with a stylet scope to the Miller blade direct laryngoscopy in manikins simulating normal and difficult pediatric airways
Acronym
A comparison of the MultiViewScope handle with a stylet scope to the direct laryngoscopy in normal and difficult pediatric airways
Scientific Title
A randomized comparison of the MultiViewScope handle with a stylet scope to the Miller blade direct laryngoscopy in manikins simulating normal and difficult pediatric airways
Scientific Title:Acronym
A comparison of the MultiViewScope handle with a stylet scope to the direct laryngoscopy in normal and difficult pediatric airways
Region
| Japan |
Condition
Condition
The normal and difficult pediatric airways
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the MultiViewScope handle with a stylet scope in pediatric airways.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to inubation
Key secondary outcomes
The success rate, the number of tracheal intubation attempts, the Cormack & Lehane grades scored by participants, the difficulty of tracheal intubation using Numerical Rating Scale (0 = very easy and 10 = very difficult) scored by participants, and the force applied to the maxilla
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The MultiViewScope handle with a stylet scope
Interventions/Control_2
The Miller blade direct laryngoscopy
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The Japanese Society of Anesthesiologists Board Certified Anesthesiologist, or the anesthesia residents
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Godai |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
8908520
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
+81992755430
kxg179@icloud.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Godai |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
8908520
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
+81992755430
Homepage URL
kxg179@icloud.com
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
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
Ethics Committee on Epidemiological Studies, Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
Tel
+81992755111
isgskkrs@kuas.kagoshima-u.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
| 2018 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
https://doi.org/10.1371/journal.pone.0237593
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1371/journal.pone.0237593
Number of participants that the trial has enrolled
30
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 | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 20 | 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
Management information
Registered date
| 2018 | Year | 07 | Month | 20 | Day |
Last modified on
| 2020 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038150
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
