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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020914
Receipt No. R000024130
Scientific Title A Randomized Control Study Comparing the Effects of Tracheal Intubation Performed Either via the McGRATH or the Macintosh Laryngoscope.
Date of disclosure of the study information 2016/02/07
Last modified on 2016/02/07

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Basic information
Public title A Randomized Control Study Comparing the Effects of Tracheal Intubation Performed Either via the McGRATH or the Macintosh Laryngoscope.
Acronym A Randomized Control Study Comparing the Effects of Tracheal Intubation Performed Either via the McGRATH or the Macintosh Laryngoscope.
Scientific Title A Randomized Control Study Comparing the Effects of Tracheal Intubation Performed Either via the McGRATH or the Macintosh Laryngoscope.
Scientific Title:Acronym A Randomized Control Study Comparing the Effects of Tracheal Intubation Performed Either via the McGRATH or the Macintosh Laryngoscope.
Region
Japan

Condition
Condition Patients of performed the tracheal intubation.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate and compare the hemodynamic changes triggered by intubation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure, Heart rate, The time needed to complete the tracheal intubation.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 McGRATH laryngoscope
Interventions/Control_2 Macintosh laryngoscope
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
50 years-old >
Gender Male and Female
Key inclusion criteria ASA status 1-2
Key exclusion criteria Difficult airway
Hypertension
Diabetes
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Murayama Naomitsu
Organization St. Mary's Hospital
Division name Department of anesthesia
Zip code
Address Fukuoka prefectur Kurume city Tuhukuhonnmachi 422
TEL 0942-35-3322
Email kgxss825@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Murayama Naomitu
Organization St. Mary's Hospital
Division name Department of anesthesia
Zip code
Address Fukuoka prefectur Kurume city Tuhukuhonnmachi 422
TEL 090-9405-4999
Homepage URL
Email kgxss825@yahoo.co.jp

Sponsor
Institute St. Mary's Hospital
Institute
Department

Funding Source
Organization St. Mary's Hospital
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 07 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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 07 Day
Last modified on
2016 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024130

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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