UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Is an endotrol-tracheal tube assisted endotracheal intubation during McGrath effective?
Title of the study (Brief title)	Is an endotrol-tracheal tube assisted endotracheal intubation during McGrath effective?
Region	Japan

Condition
Condition	general anesthesia cases with tracheal intubation in operation room
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigate how the ways the tracheal tube was intubated safely and quickly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intubation time
Key secondary outcomes	the number of intubation postoperative hoarseness and sore throat cormack classification

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	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Endotrol-tracheal tube assisted endotracheal intubation during McGrathR
Interventions/Control_2	Normal tracheal tubu assisted endotracheal intubation during McGrathR
Interventions/Control_3	Normal tracheal tubu assisted endotracheal intubation during Macintosh laryngoscope
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	cases of general anesthesia
Key exclusion criteria	cases of difficult airway the patients refused consent
Target sample size	60

Research contact person
Name of lead principal investigator	Hironobu Ueshima
Organization	Showa University Hospital
Division name	Anesthesiology
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8575
Email	ueshimhi@yahoo.co.jp

Public contact
Name of contact person	Sakatoshi Yoshiyama
Organization	Showa university hospital
Division name	Anesthesiology
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8575
Homepage URL
Email	yoshiyamax0@gmai.com

Sponsor
Institute	Showa university hospital
Institute
Department

Funding Source
Organization	Showa university hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 05 Day
Anticipated trial start date	2015 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 05 Day
Last modified on	2016 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023200