UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of hemodynamic change during intubation with McGRATH compared to Macintosh laryngoscope by inexperienced anesthetic residents. randomized control trial
Title of the study (Brief title)	Effect of hemodynamic change with intubation device.
Region	Japan

Condition
Condition	Patients who planed general anesthesia with 1 or 2 of american society of anesthesia physical status
Classification by specialty	Surgery in general Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether McGRATH videolaryngoscope suppress hemodynamic change during intubation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemodynamic change pre and post intubation
Key secondary outcomes	number of laryngoscopies, hoarseness, pharyngeal pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intubation with McGRATH videolaryngoscope
Interventions/Control_2	Intubation with Macintosh laryngoscope
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who planned general anesthesia with 1 or 2 of american society of anesthesiology physical status.
Key exclusion criteria	Patients who were not able to be intubated by anesthesia resident, were excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	Akihiro Terahata
Organization	Yokohama City University Hospital
Division name	Department of Anesthesiology
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	+81457872918
Email	shunty5323@gmail.com

Public contact
Name of contact person	shunsuke takaki
Organization	Yokohama City University
Division name	Intensive Care Medicine
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	+814578782918
Homepage URL
Email	shunty5323@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University Hospital Department of Anesthesiology
Organization
Division
Category of Funding Organization	Self funding
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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 23 Day
Anticipated trial start date	2015 Year 09 Month 01 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 08 Month 24 Day
Last modified on	2017 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021724