UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).
Title of the study (Brief title)	An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).
Region	Japan

Condition
Condition	none
Classification by specialty	Anesthesiology Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We perform internal jugular vein puncture using a novel ultrasound-guided puncture technique which combines short-axis approach and long-axis approach or conventional short-axis approach. We compare two approaches about the successful insertion of the guide-wire into the vein while visualizing the needle tip at the time of anterior wall puncture without penetrating the posterior wall in the prospective observational trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Procedural success, which is defined as successful guide-wire insertion without the occurrence of posterior wall puncture and with the needle tip visualized at the time of the anterior wall puncture.
Key secondary outcomes	The duration of the procedure.

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	Adult patients who go through operations under general anesthesia in Rakuwakai Otowa Hospital, and need for insertion of central venous catheter or pulmonary artery catheter for perioperative management.
Key exclusion criteria	Emergency operation. Patients who do not agree with this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Atsushi Fukumoto
Organization	Rakuwakai Otowa Hospital
Division name	Department of Cardiothoracic surgery
Address	2 Otowach, Chinji-cho, Yamashina-ku, Kyoto, Japan
TEL	81-75-593-4111
Email	fukumotoatsushi@gmail.com

Public contact
Name of contact person	Jun Takeshita
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Emergency and Critical Care Medicine
Address	1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL	81-75-641-9161
Homepage URL
Email	t-k-s-t@koto.kpu-m.ac.jp

Sponsor
Institute	Rakuwakai Otowa Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 09 Day
Anticipated trial start date	2015 Year 04 Month 14 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jcvaonline.com/article/S1053-0770(18)30610-4/fulltext
Results
Other related information	prospective observational cohort study

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030065