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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030204
Receipt No. R000034365
Scientific Title Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH MAC videolaryngoscope
Date of disclosure of the study information 2017/12/01
Last modified on 2019/05/30

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Basic information
Public title Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH MAC videolaryngoscope
Acronym Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH MAC videolaryngoscope
Scientific Title Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH MAC videolaryngoscope
Scientific Title:Acronym Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH MAC videolaryngoscope
Region
Japan

Condition
Condition Tracheal intubation
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate that using the distal and proximal bended intubating stylet facilitates tracheal intubation compared to the standard distal bended intubating stylet under using a McGrath MAC videolaryngoscope.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time for endotracheal tube negotiation
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Stylet forming by bending from the distal end to
the 15 cm as along the curve of the McGRATH MAC disposable blade and 60 degrees angulation at 8 cm below the proximal end of the endotracheal tube
Interventions/Control_2 Stylet forming by bending from the distal end to
the 15 cm as along the curve of the McGRATH MAC disposable blade
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 with an American Society of Anesthesiologists physical status I or II who are undergoing elective surgery and requiring oral tracheal intubation
Key exclusion criteria Patients who required rapid sequence induction; had a history of previous difficult tracheal intubation; were unwilling to provide informed consent; had uncontrolled hypertension; had a history of ischaemic heart disease; had aneurysm, had a history of stroke or cerebral hemorrhage; had cervical spine instability or cervical myelopathy; had symptomatic asthma or reactive airway disease requiring daily pharmacological treatment for control of symptoms; or had a history of gastric reflux
Target sample size 56

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Wakabayashi
Organization Hokushin General Hospital
Division name Department of Anesthesiology
Zip code 383-8505
Address 1-5-63, Nishi, Nakano, Nagano, Japan
TEL 81-269-22-2151
Email waka0924@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Wakabayashi
Organization Hokushin General Hospital
Division name Department of Anesthesiology
Zip code 383-8505
Address 1-5-63, Nishi, Nakano, Nagano, Japan
TEL +81-269-22-2151
Homepage URL
Email waka0924@shinshu-u.ac.jp

Sponsor
Institute Hokushin General Hospital
Institute
Department

Funding Source
Organization Hokushin General Hospital
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 Hokushin General Hospital
Address 1-5-63, Nishi, Nakano, Nagano, Japan
Tel +81-269-22-2151
Email hokubyou@hokushin-hosp.jp

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
2017 Year 12 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 Completed
Date of protocol fixation
2017 Year 11 Month 15 Day
Date of IRB
2017 Year 11 Month 15 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034365

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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