UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025304 |
|---|---|
| Receipt number | R000029067 |
| Scientific Title | Usefulness of ultrasonography for appropriate longitudinal guidewire imaging during internal jugular central venous catheter placement |
| Date of disclosure of the study information | 2016/12/16 |
| Last modified on | 2020/10/05 14:20:42 |
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Basic information
Public title
Usefulness of ultrasonography for appropriate longitudinal guidewire imaging during internal jugular central venous catheter placement
Acronym
Usefulness of ultrasonography for appropriate longitudinal guidewire imaging during internal jugular central venous catheter placement
Scientific Title
Usefulness of ultrasonography for appropriate longitudinal guidewire imaging during internal jugular central venous catheter placement
Scientific Title:Acronym
Usefulness of ultrasonography for appropriate longitudinal guidewire imaging 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 determine the rate of successful depiction of appropriate longitudinal guidewire imaging during internal jugular central venous catheter placement
Basic objectives2
Others
Basic objectives -Others
To identify the factors contributing to successful visualization of appropriate guidewire imaging during internal jugular central venous catheter placement
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of successful depiction of appropriate longitudinal guidewire imaging during internal jugular central venous catheter placement
Key secondary outcomes
To identify the factors contributing to successful visualization of appropriate guidewire imaging 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
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
waka0924@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine, Department of Anesthesiology and Resuscitology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 08 | 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
Written informed consent was obtained from all patients before enrollment.
Management information
Registered date
| 2016 | Year | 12 | Month | 16 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029067
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
