UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013411 |
|---|---|
| Receipt number | R000015635 |
| Scientific Title | Randomised controlled trial comparing the effect of Jaw Elevation Device and manual assist during fiberoptic intubation. |
| Date of disclosure of the study information | 2014/03/13 |
| Last modified on | 2014/03/13 15:42:50 |
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Basic information
Public title
Randomised controlled trial comparing the effect of Jaw Elevation Device and manual assist during fiberoptic intubation.
Acronym
Randomised controlled trial comparing the effect of Jaw Elevation Device and manual assist during fiberoptic intubation.
Scientific Title
Randomised controlled trial comparing the effect of Jaw Elevation Device and manual assist during fiberoptic intubation.
Scientific Title:Acronym
Randomised controlled trial comparing the effect of Jaw Elevation Device and manual assist during fiberoptic intubation.
Region
| Japan |
Condition
Condition
Patient who are undergoing operation under general anesthesia
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Anesthesiology | Oral surgery |
| Neurosurgery | Cardiovascular surgery | Operative medicine |
| Emergency medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the effect of JED and manual assist
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time needed to intubate
Key secondary outcomes
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Jaw Elevation Device
Interventions/Control_2
Jaw elevation by assistant
Interventions/Control_3
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 who are undergoing elective surgery under general anesthesia
Key exclusion criteria
Patients with pharynx and larynx disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimura Seiko |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1 kimiidera, Wakayama city, Wakayama ,Japan
TEL
073-447-2300
seikoy@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimura Seiko |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
Address
811-1 kimiidera, Wakayama city, Wakayama ,Japan
TEL
073-447-2300
Homepage URL
seikoy@hotmail.co.jp
Sponsor or person
Institute
Department of Anesthesiology,Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
As well as manual jaw elevation, JED is a valuable device to provide good visualization of the glottis during fibreoptic intubation.
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
| 2012 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 02 | 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 | 03 | Month | 13 | Day |
Last modified on
| 2014 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015635
