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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025304
Receipt No. R000029067
Scientific Title Efficacy of transesophageal echocardiography in confirmation of the guidewire position during internal jugular central venous catheterization
Date of disclosure of the study information 2016/12/16
Last modified on 2018/01/24

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Basic information
Public title Efficacy of transesophageal echocardiography in confirmation of the guidewire position during internal jugular central venous catheterization
Acronym Efficacy of transesophageal echocardiography in confirmation of the guidewire position during internal jugular central venous catheterization
Scientific Title Efficacy of transesophageal echocardiography in confirmation of the guidewire position during internal jugular central venous catheterization
Scientific Title:Acronym Efficacy of transesophageal echocardiography in confirmation of the guidewire position during internal jugular central venous catheterization
Region
Japan

Condition
Condition Participants undergoing elective surgery planned to insert internal jugular central venous catheter and utilize transesophageal echocardiography
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the success rate of visualization of the guidewire between utilizing ultrasonography and transesophageal echocardiography during internal jugular central venous catheterization
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification rates of the proper guidewire position
with percutaneous ultrasonography and transesophageal echocardiography
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 Participants aged 20 years or older who is undergoing elective surgery planned to insert internal jugular central venous catheter and utilize transesophageal echocardiography
Key exclusion criteria Patients with obesity (Body Mass Index > 30), history of previous surgical intervention at the cannulation site, infection signs or subcutaneous hematoma or subcutaneous emphysema close to the puncture site, neck immobilization, upper gastrointestinal surgery, contraindication of TEE, and pacemaker lead placement were excluded.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Wakabayashi
Organization Shinshu University Hospital
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1, Asahi, Matsumoto-shi, Nagano
TEL 0263-37-2670
Email waka0924@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Wakabayashi
Organization Shinshu University Hospital
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1, Asahi, Matsumoto-shi, Nagano
TEL 0263-37-2670
Homepage URL
Email waka0924@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital, Department of Anesthesiology and Resuscitology
Institute
Department

Funding Source
Organization Shinshu University Hospital, Department of Anesthesiology and Resuscitology
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 12 Month 16 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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We investigate the success rate of visualization of the guidewire utilizing ultrasonography or transesophageal echocardiography during internal jugular central venous catheterization

Management information
Registered date
2016 Year 12 Month 16 Day
Last modified on
2018 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029067

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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