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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025896
Receipt No. R000028972
Scientific Title The efficacy of using articulating stylet in the tracheal intubation
Date of disclosure of the study information 2017/02/01
Last modified on 2017/12/19

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Basic information
Public title The efficacy of using articulating stylet
in the tracheal intubation
Acronym The efficacy of using articulating stylet
in the tracheal intubation
Scientific Title The efficacy of using articulating stylet
in the tracheal intubation
Scientific Title:Acronym 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
1st name
Middle name
Last name Masaharu Yamaga
Organization University of Miyazaki
Division name Departments of Anesthesiology
Zip code
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
1st name
Middle name
Last name Masaharu Yamaga
Organization University of Miyazaki
Division name Departments of Anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2015 Year 10 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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