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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028528
Receipt No. R000022955
Scientific Title A Comparative Review of Airwayscope and Styletscope in case of CVCI
Date of disclosure of the study information 2017/08/03
Last modified on 2017/08/03

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Basic information
Public title A Comparative Review of Airwayscope and Styletscope in case of CVCI
Acronym A Comparative Review of Intubation devices in case of CSM
Scientific Title A Comparative Review of Airwayscope and Styletscope in case of CVCI
Scientific Title:Acronym A Comparative Review of Intubation devices in case of CSM
Region
Japan

Condition
Condition cervical spondylotic myelopathy
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of the usefulness of the stylet scope
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The intubation time, and Change of vital signs, especially blood pressure, heart rate,and SpO2
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 We use an air way scope for tracheal intubation. We cancel a study three times when it is hard to intubate it even if it takes effect.
Interventions/Control_2 We use a stylet scope for tracheal intubation. We cancel a study three times when it is hard to intubate it even if it takes effect.
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
45 years-old <=
Age-upper limit
94 years-old >=
Gender Male and Female
Key inclusion criteria The patients who receive a diagnosis of the cervical spondylotic myelopathy, and undergo cervical vertebrae laminoplasty
Key exclusion criteria The patients who requried Subconscious fiber intubation, that an agreement was not obtained beforehand, are stage of more than ASA3
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIRANO HIROKO
Organization CHUBU ROSAI Hospital
Division name Anesthesiology
Zip code
Address 1-10-6 Koumei Minatoku Nagoya City Aichi Prefecture
TEL 052-652-5511
Email hrk0203ykng@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name HIRANO HIROKO
Organization CHUBU ROSAI Hospital
Division name Anesthesiology
Zip code
Address 1-10-6 Koumei Minatoku Nagoya City Aichi Prefecture
TEL 052-652-5511
Homepage URL
Email hrk0203ykng@gmail.com

Sponsor
Institute Anesthesiology of CHUBU ROSAI Hospital
Institute
Department

Funding Source
Organization no
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
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
2017 Year 08 Month 03 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 Open public recruiting
Date of protocol fixation
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2016 Year 04 Month 30 Day
Date of closure to data entry
2016 Year 04 Month 30 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded
2016 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022955

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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