UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of using articulating stylet in the tracheal intubation
Title of the study (Brief title)	The efficacy of using articulating stylet in the tracheal intubation
Region	Japan

Condition
Condition	the patient who need trachal intubation for opelation
Classification by specialty	Anesthesiology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The Flex-It rticulating stylet (Parker Medical, Highlands Ranch, CO) is a 2-piece plastic stylet that allows active modification of the stylet camber during use and can be temporarily locked into a specific curvature with a locking clip. The Flex-It stylet can be used for nasal, as well as oral, intubation. The aims of this randomized open-label study are to compare this Parker Flex-It stylet with a conventional metallic stylet using laryngoscope or videolaryngoscope during orotracheal intubation, or with Magiru forceps during nasal intubation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The time for tracheal intubation
Key secondary outcomes	1) success rate of tracheal intubation 2) any complications while inserting or taking out the blade and the tube

Base
Study type	Interventional

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

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Parker Flex-It stylet using laryngoscope during orotracheal intubation
Interventions/Control_2	conventional metallic stylet using laryngoscope during orotracheal intubation
Interventions/Control_3	Parker Flex-It stylet using videolaryngoscope during orotracheal intubation
Interventions/Control_4	conventional metallic stylet using videolaryngoscope during orotracheal intubation
Interventions/Control_5	Parker Flex-It stylet during nasal intubation
Interventions/Control_6	Magiru forceps during nasal intubation
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	American Society of Anesthesiologists physical status (ASA) I-III patients scheduled for elective surgery under general anaesthesia were prospectively enrolled
Key exclusion criteria	1) younger than 20 years of age 2) anticipated difficult airway: past history of cervical surgery or radiation therapy for the neck or trismus
Target sample size	200

Research contact person
Name of lead principal investigator	Masaharu Yamaga
Organization	University of Miyazaki
Division name	Departments of Anesthesiology
Address	Kihara 5200 Kiyotake town, Miyazaki City,Miyazaki , Japan
TEL	0985-85-9357
Email	masaharu_yamaga@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Masaharu Yamaga
Organization	University of Miyazaki
Division name	Departments of Anesthesiology
Address	Kihara 5200 Kiyotake town, Miyazaki City,Miyazaki , Japan
TEL	0985-85-9355
Homepage URL
Email	masaharu_yamaga@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

Funding Source
Organization	University of Miyazaki
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	宮崎大学附属病院（宮崎県）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 29 Day
Anticipated trial start date	2016 Year 02 Month 09 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry	2017 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded	2017 Year 11 Month 30 Day

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

Management information
Registered date	2017 Year 01 Month 30 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028972