UMIN-CTR Clinical Trial

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