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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012828
Receipt No. 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

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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
Email 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
Email marumaru@wj9.so-net.ne.jp

Sponsor
Institute department of anesthesiology, Showa University Fujigaoka Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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