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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018631
Receipt No. R000021558
Scientific Title The study of using McGrath laryngoscope for insertion of transesophageal echocardiography probe
Date of disclosure of the study information 2015/08/14
Last modified on 2015/08/10

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Basic information
Public title The study of using McGrath laryngoscope for insertion of transesophageal echocardiography probe
Acronym The study of using McGrath laryngoscope for insertion of transesophageal echocardiography probe
Scientific Title The study of using McGrath laryngoscope for insertion of transesophageal echocardiography probe
Scientific Title:Acronym The study of using McGrath laryngoscope for insertion of transesophageal echocardiography probe
Region
Japan

Condition
Condition All diseases that require transesophageal echocardiography
Classification by specialty
Surgery in general Vascular surgery Breast surgery
Cardiovascular surgery Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether insertion of a transesophageal echocardiography
probe using McGRATH MAC video laryngoscope
is good or not.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The duration of transesophageal echocardiography probe insertion
Key secondary outcomes number of the trial
postoperateive sore throat
hemodynamic change
Evaluation by the anesthesiologist

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 McGrath group:McGrath MAC laryngoscope is used to visualize the passage of a transesophageal echocardiography probe.
Interventions/Control_2 Control group:a transesophageal echocardiography probe is inserted blindly.
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 scheduled for elective surgery that need transesophageal echocardiography.
Key exclusion criteria Patients that transesophageal echocardiography is contraindicated and with instability in the cervical spine are excluded
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Terahata
Organization Yokohama City University
Division name Department of Anesthesiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-787-2918
Email anesthes@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Terahata
Organization Yokohama City University
Division name Department of Anesthesiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-787-2918
Homepage URL
Email anesthes@yokohama-cu.ac.jp

Sponsor
Institute Department of Anesthesiology, Yokohama City University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
2015 Year 08 Month 14 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 Preinitiation
Date of protocol fixation
2015 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 14 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
2015 Year 08 Month 10 Day
Last modified on
2015 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021558

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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