UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012828 |
|---|---|
| Receipt number | R000014985 |
| Scientific Title | Comparison of the usability of Airtraq, Kingvision and Airwayscope for oral intubation in normal airway patients. |
| Date of disclosure of the study information | 2014/01/11 |
| Last modified on | 2017/01/02 16:40:36 |
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Basic information
Public title
Comparison of the usability of Airtraq, Kingvision and Airwayscope for oral intubation in normal airway patients.
Acronym
Comparison of the usability of Airtraq, Kingvision and Airwayscope for oral intubation.
Scientific Title
Comparison of the usability of Airtraq, Kingvision and Airwayscope for oral intubation in normal airway patients.
Scientific Title:Acronym
Comparison of the usability of Airtraq, Kingvision and Airwayscope for oral intubation.
Region
| Japan |
Condition
Condition
patients scheduled for elective operation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluated the usability of three types of indirect laryngoscope, Airtraq(ATQ), Kingvision(KV) and Airwayscope(AWS), for routine airway management in terms of intubation time and the view of the glottis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
time to intubation, view of glottis
Key secondary outcomes
adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Airtraq group:30
Interventions/Control_2
Airwayscope group:30
Interventions/Control_3
Kingvision:30
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
patients scheduled for elective operation and required general anesthesia and tracheal intubation
Key exclusion criteria
Anesthesiologists physical status 4, history of cervical spine injury, difficult airway
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terumi Marui |
Organization
Showa University Fujigaoka Hospital
Division name
department of Anesthesiology
Zip code
Address
1-30, Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa-prefecture
TEL
045-971-1151
marumaru@wj9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terumi Marui |
Organization
Showa University Fujigaoka Hospital
Division name
department of anesthesiology
Zip code
Address
1-30, Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa-prefecture, Japan
TEL
045-971-1151
Homepage URL
marumaru@wj9.so-net.ne.jp
Sponsor or person
Institute
department of anesthesiology, Showa University Fujigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
department of anesthesiology, Showa University Fujigaoka 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
Address
Tel
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
| 2014 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 11 | Day |
Last modified on
| 2017 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014985
