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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023018
Receipt No. R000025245
Scientific Title Evaluation of lip pulling outside effect for laryngoscopy: a randomized crossover trial
Date of disclosure of the study information 2016/07/05
Last modified on 2016/09/07

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Basic information
Public title Evaluation of lip pulling outside effect for laryngoscopy: a randomized crossover trial
Acronym Evaluation of lip pulling outside effect for laryngoscopy
Scientific Title Evaluation of lip pulling outside effect for laryngoscopy: a randomized crossover trial
Scientific Title:Acronym Evaluation of lip pulling outside effect for laryngoscopy
Region
Japan

Condition
Condition Patients undergoing general anesthesia
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of lip pulling outside method for laryngoscopy grade.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Laryngoscopy grade (such as Cormack grade, POGO score)
Key secondary outcomes Subjective difficulty of laryngoscopy

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1Lip pulling outside 2Not lip pulling outside
Interventions/Control_2 1Not lip pulling outside 2lip pulling outside
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing general anesthesia
Key exclusion criteria Patients contraindicated for rapid induction.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuk city
TEL 0726-84-6361
Email ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyasu Komasawa
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 Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
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
2016 Year 07 Month 05 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
Lip ettraction method significantly improve laryngoscopy measure  by Cormack grade or POGO score.
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
2016 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 10 Day
Last follow-up date
2016 Year 08 Month 30 Day
Date of closure to data entry
2016 Year 08 Month 31 Day
Date trial data considered complete
2016 Year 08 Month 31 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information Subjective difficulty of laryngoscopy by anesthesiologists also signfiicnatly improved.

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2016 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025245

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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