UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025896 |
|---|---|
| Receipt number | 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 10:53:04 |
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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
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
masaharu_yamaga@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028972
