UMIN-CTR Clinical Trial

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 Ritsuko Middle name Last name Masuda
Organization	Hachioji-hospital, Tokai University School of Medicine, Hachioji
Division name	Department of Anesthesiology
Zip code	1920032
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 Junko Middle name Last name Ajimi
Organization	Hachioji-hospital, Tokai University School of Medicine, Hachioji
Division name	Department of Anesthesiology
Zip code	1920032
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	Clinical Research Administration Office ,Tokai UniversityHospital
Address	143 Shimokasuya, Isehara, Kanagawa
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.jp

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	2017 Year 07 Month 25 Day
Anticipated trial start date	2017 Year 07 Month 31 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 04 Month 12 Day
Last modified on	2021 Year 06 Month 21 Day

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