UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015075 |
|---|---|
| Receipt number | 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 13:51:37 |
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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
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
takemi@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Department of Anesthesiology and Resuscitology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017541
