UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015831 |
|---|---|
| Receipt number | R000018419 |
| Scientific Title | The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement |
| Date of disclosure of the study information | 2014/12/04 |
| Last modified on | 2014/12/03 14:44:48 |
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Basic information
Public title
The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement
Acronym
The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement
Scientific Title
The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement
Scientific Title:Acronym
The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement
Region
| Japan |
Condition
Condition
intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the King Vision TM in difficult airway model with restriction cervical spine movement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intubation time
Key secondary outcomes
number of attempts, success rate of intubation, difficulty of the intubation attempts,cervical spine movement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
intubation of the King Vision TM in difficult airway model with restriction cervical spine movement
Interventions/Control_2
intubation of the PENTAX Airway Scope in difficult airway model with restriction cervical spine movement
Interventions/Control_3
intubation of the Macintosh laryngoscope in difficult airway model with restriction cervical spine movement
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ASA1-2
scheduled elective surgery
general anesthesia
Key exclusion criteria
emergency surgery
severe heart disease,
severe respiratory disease
gastroesophageal reflex disease
pregnancy
expected difficult l airway
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Akihisa |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Anesthesiology
Zip code
Address
3-8-3Mizonokuchi, Takatsu, Kawasaki, Kanagawa
TEL
044-844-3333
ypegtj25@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Akihisa |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Anesthesiology
Zip code
Address
3-8-3Mizonokuchi, Takatsu, Kawasaki, Kanagawa
TEL
044-844-3333
Homepage URL
ypegtj25@yahoo.co.jp
Sponsor or person
Institute
Mizonokuchi Hospital, Teikyo University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Other
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 | 12 | Month | 04 | 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 | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 04 | 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 | 12 | Month | 03 | Day |
Last modified on
| 2014 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018419
