UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of intubation efficacy evaluation with or without stylet
Title of the study (Brief title)	Intubation efficacy evaluation with or without stylet
Region	Japan

Condition
Condition	Patient who undergo general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of stylet for tracehal intubation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intubation time times of laryngoscopy progression time
Key secondary outcomes	Patient characteristics

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Tracehal intubation with stylet
Interventions/Control_2	Tracheal intubation without stylet
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patient who undergo general anesthesia
Key exclusion criteria	Crash induction Prone DLT
Target sample size	50

Research contact person
Name of lead principal investigator	Nobuyasu Komasawa
Organization	Osaka Medical College
Division name	Anesgthesiology
Address	2-7 Daigaku-machi, Takatsuk city
TEL	0726-84-6361
Email	ane078@poh.osaka-med.ac.jp

Public contact
Name of contact person	Komasawa Nobuyasu
Organization	Osaka Medical College
Division name	Anesthesiology
Address	2-7Daigaku-machi, Takatsuki city
TEL	0726-84-6361
Homepage URL
Email	ane078@poh.osaka-med.ac.jp

Sponsor
Institute	Hokusetsu General Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hokusetsu General Hospital
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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 23 Day
Anticipated trial start date	2015 Year 07 Month 31 Day
Last follow-up date	2016 Year 05 Month 10 Day
Date of closure to data entry	2016 Year 05 Month 12 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Pharyngeal pain was significantly higher in the stylet group than in the control group.
Other related information	There were no sigifnicant difference between the stylet and non-stylet group about the incidence of postoperative hoarseness.

Management information
Registered date	2015 Year 07 Month 30 Day
Last modified on	2016 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020461