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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013411
Receipt No. 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

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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 Obsterics 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
Email 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
Email seikoy@hotmail.co.jp

Sponsor
Institute Department of Anesthesiology,Wakayama Medical University
Institute
Department

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
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 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015635

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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