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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018488
Receipt No. R000020461
Scientific Title Evaluation of intubation efficacy evaluation with or without stylet
Date of disclosure of the study information 2015/07/31
Last modified on 2016/05/11

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Basic information
Public title Evaluation of intubation efficacy evaluation with or without stylet
Acronym Intubation efficacy evaluation with or without stylet
Scientific Title Evaluation of intubation efficacy evaluation with or without stylet
Scientific Title:Acronym Intubation efficacy evaluation with or without stylet
Region
Japan

Condition
Condition Patient who undergo general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of stylet for tracehal intubation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intubation time
times of laryngoscopy
progression time
Key secondary outcomes Patient characteristics

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Tracehal intubation with stylet
Interventions/Control_2 Tracheal intubation without stylet
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
85 years-old >
Gender Male and Female
Key inclusion criteria Patient who undergo general anesthesia
Key exclusion criteria Crash induction
Prone
DLT
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyasu Komasawa
Organization Osaka Medical College
Division name Anesgthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuk city
TEL 0726-84-6361
Email ane078@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Komasawa Nobuyasu
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7Daigaku-machi, Takatsuki city
TEL 0726-84-6361
Homepage URL
Email ane078@poh.osaka-med.ac.jp

Sponsor
Institute Hokusetsu General Hospital
Institute
Department

Funding Source
Organization Hokusetsu General Hospital
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
2015 Year 07 Month 31 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 Pharyngeal pain was significantly higher in the stylet group than in the control group.
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
2015 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 31 Day
Last follow-up date
2016 Year 05 Month 10 Day
Date of closure to data entry
2016 Year 05 Month 12 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information There were no sigifnicant difference between the stylet and non-stylet group about the incidence of postoperative hoarseness.

Management information
Registered date
2015 Year 07 Month 30 Day
Last modified on
2016 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020461

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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