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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032214
Receipt No. R000036721
Scientific Title clinical evaluation of videolaryngoscopes
Date of disclosure of the study information 2018/04/13
Last modified on 2018/04/12

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Basic information
Public title clinical evaluation of videolaryngoscopes
Acronym clinical evaluation of videolaryngoscopes
Scientific Title clinical evaluation of videolaryngoscopes
Scientific Title:Acronym clinical evaluation of videolaryngoscopes
Region
Japan

Condition
Condition thoracic surgeries entailing double-lumen tube placement
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Recently, different types of video laryngoscopes have been reported for use in double-lumen tube intubation. However, the advantages and disadvantages between them remain undetermined for DLT intubation. This study aimed to compare the utility of AirtraqTM double lumen , McGRATHTM MAC video laryngoscope and the Pentax-AWS AirwayscopeTM for double-lumen endotracheal tube intubation in patients undergoing elective surgery by one experienced anesthesiologist.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intubation time
Key secondary outcomes laryngoscopic view

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Airtraq double lumen(+)
McGRATHTM MAC video laryngoscope (-)
Pentax-AWS Airwayscope (-)
Interventions/Control_2 Airtraq double lumen(-)
McGRATHTM MAC video laryngoscope (+)
Pentax-AWS Airwayscope (-)
Interventions/Control_3 Airtraq double lumen(-)
McGRATHTM MAC video laryngoscope (-)
Pentax-AWS Airwayscope (+)
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 American Society of Anesthesiologists physical status 1 to 3
Key exclusion criteria American Society of Anesthesiologists physical status 4
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ritsuko Masuda
Organization Hachioji-hospital, Tokai University School of Medicine, Hachioji
Division name Department of Anesthesiology
Zip code
Address 1838 Ishikawamachi, Hachioji, Tokyo
TEL 042-639-1111
Email rinet-m@ga2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Ajimi
Organization Hachioji-hospital, Tokai University School of Medicine, Hachioji
Division name Department of Anesthesiology
Zip code
Address 1838 Ishikawamachi, Hachioji, Tokyo
TEL 042-639-1111
Homepage URL
Email ajimi@is.icc.u-tokai.ac.jp

Sponsor
Institute Hachioji-hospital, Tokai University School of Medicine, Hachioji

Department of Anesthesiology
Institute
Department

Funding Source
Organization Hachioji-hospital, Tokai University School of Medicine, Hachioji

Department of Anesthesiology
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 東海大学医学部付属八王子病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 13 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 12 Day
Last modified on
2018 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036721

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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