UMIN-CTR Clinical Trial

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)
Email	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
Email	bc-vn400d@hotmail.co.jp

Sponsor
Institute	Yokosuka kyosai hospital
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030151