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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015075
Receipt No. R000017541
Scientific Title Study of clinical usefulness of video laryngoscope: comparison of VLP-100, Airway scope and McGrath MAC
Date of disclosure of the study information 2014/09/07
Last modified on 2014/09/06

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Basic information
Public title Study of clinical usefulness of video laryngoscope: comparison of VLP-100, Airway scope and McGrath MAC
Acronym Study of clinical usefulness of video laryngoscope
Scientific Title Study of clinical usefulness of video laryngoscope: comparison of VLP-100, Airway scope and McGrath MAC
Scientific Title:Acronym Study of clinical usefulness of video laryngoscope
Region
Japan

Condition
Condition difficult airway
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The comparative study VLP-100, Airway scope, and McGrath MAC, to reveal the usefulness and features of each.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Cormack Lehane classification
(2) Durations required for intubation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients who are scheduled to undergo elective surgery under general anesthesia were enrolled in this study. Patients are randomly assigned to one of three video laryngoscope groups: group VLP-100, group Airway scope, and group McGrath MAC. Group VLP-100 are intubated with VLP-100.
Interventions/Control_2 Patients who are scheduled to undergo elective surgery under general anesthesia were enrolled in this study. Patients are randomly assigned to one of three video laryngoscope groups: group VLP-100, group Airway scope, and group McGrath MAC. Group Airway scope are intubated with Airway scope.
Interventions/Control_3 Patients who are scheduled to undergo elective surgery under general anesthesia were enrolled in this study. Patients are randomly assigned to one of three video laryngoscope groups: group VLP-100, group Airway scope, and group McGrath MAC. Group McGrath MAC are intubated with McGrath MAC.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were scheduled to undergo elective surgery under general anesthesia are enrolled in this study.
Key exclusion criteria Patients with predictors of difficult intubation are excluded.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikito Kawamata
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address asahi3-1-1, matumoto city, nagano, Japan
TEL 0263-37-2670
Email kawamata@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takemi Sekiguchi
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address asahi3-1-1, matumoto city, nagano, Japan
TEL 0263-37-2670
Homepage URL
Email takemi@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Department of Anesthesiology and Resuscitology
Institute
Department

Funding Source
Organization Shinshu University School of Medicine
Department of Anesthesiology and Resuscitology
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 09 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2014 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 10 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 09 Month 06 Day
Last modified on
2014 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017541

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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