UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The optimal insertion depth of the peripherally inserted central venous catheter using the ultrasound imaging
Title of the study (Brief title)	The insertion depth of the peripherally inserted central venous catheter using the ultrasound
Region	Japan

Condition
Condition	Patiens who is required to place the central venous catheter.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to predict the optimal insertion depth of the peripherally inserted central venous catheter using the ultrasound imaging and external landmarks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The distance between a catheter tip and the carina by chest X-ray.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	period: October 27, 2014 to March 31, 2016. We confirm the catheter tip in the subclavian vein using ultrasound image, then the external distance between catheter tip and the second right costal cartilage to the manubriosternal joint was measured. The catheter was inserted and secured to the depth determined ultrasound and external landmarks.
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	Patiens who is required to place the central venous catheter.
Key exclusion criteria	Inflammation, infection, mass at the puncture site. the catheter insertion site except for the arm is preferred. the catheter insertion on the arm is difficult. Patients who is determined inadequate by the administrator.
Target sample size	20

Research contact person
Name of lead principal investigator	Kouhei Iwashita
Organization	Faculty of medicine, Fukuoka University
Division name	Anesthesiology
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Email	iwashita@fukuoka-u.ac.jp

Public contact
Name of contact person	Kouhei Iwashita
Organization	Faculty of medicine, Fukuoka University
Division name	Anesthesiology
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka
TEL	092-801-1011
Homepage URL
Email	iwashita@fukuoka-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Fukuoka University
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	2014 Year 11 Month 08 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 22 Day
Anticipated trial start date	2014 Year 11 Month 08 Day
Last follow-up date	2015 Year 03 Month 17 Day
Date of closure to data entry	2015 Year 03 Month 17 Day
Date trial data considered complete	2015 Year 03 Month 17 Day
Date analysis concluded	2018 Year 02 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 11 Month 08 Day
Last modified on	2018 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018172