UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026252 |
|---|---|
| Receipt number | R000030151 |
| Scientific Title | Evaluation of anatomical landmark method based on computed tomography for optimal placement of the central venous catheter via right internal jugular vein. |
| Date of disclosure of the study information | 2017/02/21 |
| Last modified on | 2022/02/25 22:46:40 |
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Basic information
Public title
Evaluation of anatomical landmark method based on computed tomography for optimal placement of the central venous catheter via right internal jugular vein.
Acronym
Evaluation of anatomical landmark method based on computed tomography for optimal placement of the central venous catheter via right internal jugular vein.
Scientific Title
Evaluation of anatomical landmark method based on computed tomography for optimal placement of the central venous catheter via right internal jugular vein.
Scientific Title:Acronym
Evaluation of anatomical landmark method based on computed tomography for optimal placement of the central venous catheter via right internal jugular vein.
Region
| Japan |
Condition
Condition
Patients who require central venous catheter insertion under general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this confirmatory study is to predict the optimal insertion depth of the central venous catheter using external landmarks corresponding to Zone B identified by computed tomography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of the central venous catheter tip within Zone B estimated from postoperative chest X-ray.
Key secondary outcomes
The distance between the center of Zone B and the central venous catheter tip.
Frequency of adverse events related to central venous catheter insertion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The distance between the central venous catheter insertion point and the external landmark is measured prior to catheter insertion. We plug the value into the linear equation, a prediction formula for optimal catheter placement, which was derived from the pilot study data. The catheter insertion depth is calculated using the equation.
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 who require central venous catheter insertion via right internal jugular vein under general anesthesia and had undergone computed tomography for diagnosis.
Key exclusion criteria
Patients with vascular malformation, narrowed right internal jugular vein, right internal jugular vein thrombosis, thoracic deformity, and right postmastectomy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Kida |
Organization
Yokosuka kyosai hospital
Division name
Department of anesthesiology
Zip code
Address
1-16 Yonegahama street, Yokosuka-shi
TEL
046-822-2710(ext.7046)
bc-vn400d@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Kida |
Organization
Yokosuka kyosai hospital
Division name
Department of anesthesiology
Zip code
Address
1-16 Yonegahama street, Yokosuka-shi
TEL
046-822-2710(ext.7046)
Homepage URL
bc-vn400d@hotmail.co.jp
Sponsor or person
Institute
Yokosuka kyosai hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 02 | Month | 21 | 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
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030151
