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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025304
Receipt No. R000029067
Scientific Title Appropriateness and limitations of percutaneous ultrasonography for guidewire imaging to prevent inadvertent arterial catheterization during internal jugular central venous catheter placement
Date of disclosure of the study information 2016/12/16
Last modified on 2019/11/17

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Basic information
Public title Appropriateness and limitations of percutaneous ultrasonography for guidewire imaging to prevent inadvertent arterial catheterization during internal jugular central venous catheter placement
Acronym Appropriateness and limitations of percutaneous ultrasonography for guidewire imaging to prevent inadvertent arterial catheterization during internal jugular central venous catheter placement
Scientific Title Appropriateness and limitations of percutaneous ultrasonography for guidewire imaging to prevent inadvertent arterial catheterization during internal jugular central venous catheter placement
Scientific Title:Acronym Appropriateness and limitations of percutaneous ultrasonography for guidewire imaging to prevent inadvertent arterial catheterization during internal jugular central venous catheter placement
Region
Japan

Condition
Condition Patients undergoing elective surgery scheduled for internal jugular central venous catheter placement and intraoperative transesophageal echocardiography monitoring
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate incidence of appropriate guidewire imaging for prevention of inadvertent arterial catheterization by percutaneous ultrasonography compared with transesophageal echocardiography during internal jugular central venous catheter placement
Basic objectives2 Others
Basic objectives -Others To elucidate independent risk factors for failed visualization of appropriate guidewire image for prevention of inadvertent arterial catheterization by percutaneous ultrasonography during internal jugular central venous catheter placement
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of appropriate guidewire imaging for prevention of inadvertent arterial catheterization by percutaneous ultrasonography and by transesophageal echocardiography during internal jugular central venous catheter placement
Key secondary outcomes Independent risk factors for failed visualization of appropriate guidewire image for prevention of inadvertent arterial catheterization by percutaneous ultrasonography during internal jugular central venous catheter placement

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 Patients aged 20 years or older who are scheduled to undergo elective surgery under general anesthesia and who required central venous catheterization via the right internal jugular vein and intraoperative transesophageal echocardiography monitoring
Key exclusion criteria Exclusion criteria includes a history of neck surgery, cervical vertebra disease or cervical myelopathy, the presence of infection, hematoma or subcutaneous emphysema of the neck, anatomical abnormality of blood vessels in the neck or chest including persistent left superior vena cava, heart rhythm device leads, and contraindications to TEE such as perforated viscus or esophageal stricture.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Wakabayashi
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code 390-8621
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 Ryo
Middle name
Last name Wakabayashi
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code 390-8621
Address 3-1-1, Asahi, Matsumoto, Nagano
TEL 0263-37-2670
Homepage URL
Email waka0924@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine, Department of Anesthesiology and Resuscitology
Institute
Department

Funding Source
Organization Shinshu University School of Medicine, 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 Shinshu University School of Medicine, Institutional Review Board
Address 3-1-1, Asahi, Matsumoto, Nagano
Tel 0263-37-2572
Email mdrinri@shinshu-u.ac.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
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
2016 Year 11 Month 20 Day
Anticipated trial start date
2016 Year 12 Month 19 Day
Last follow-up date
2019 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate incidence of appropriate guidewire imaging for prevention of inadvertent arterial catheterization by percutaneous ultrasonography compared with transesophageal echocardiography during internal jugular central venous catheter placement

Management information
Registered date
2016 Year 12 Month 16 Day
Last modified on
2019 Year 11 Month 17 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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