UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of prominent factors and preventive mesasures of mechanical complication of central venous catheter insertion
Acronym	Mechanical complication of central venous catheter insertion
Scientific Title	Investigation of prominent factors and preventive mesasures of mechanical complication of central venous catheter insertion
Scientific Title:Acronym	Mechanical complication of central venous catheter insertion
Region	Japan

Condition
Condition	All of the diseases and medical status of the patients applied for central venous catheter insertion
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to prevent mechanical complications of central venous catheter insertion, we will retrospectively investigate prominent factors related to mechanical complication of central venous catheter insertion.
Basic objectives2	Others
Basic objectives -Others	Preventive measures for mechanical complication of central venous catheter insertion
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcomes are mechanical complications such as arterial punctuation, hematoma, pneumothorax, failure of catheter insertion and catheter migration.
Key secondary outcomes

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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with central venous catheter insertion
Key exclusion criteria	Many deficits on the records of observation of central venous catheter insertion
Target sample size	20000

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name Yorozu
Organization	Kyorin Universiy, School of Medicine
Division name	Dept. of Anesthesiology
Zip code	181-8611
Address	6-20-2 Shinkawa, MItaka City Tokyo
TEL	0422475511
Email	tyorozu@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Tomoko Middle name Last name Yorozu
Organization	Kyorin Universiy, Faculty of Medicine
Division name	Dep of Anesthesiology
Zip code	181-8611
Address	6-20-2 Shinkawa, MItaka City Tokyo
TEL	0422475511
Homepage URL	http://www.kyorin-u.ac.jp/univ/user/medicine/masuika/
Email	kyorinanesth@gmail.com

Sponsor
Institute	Dept. of Anesthesiology, Kyorin University, School of Medicine
Institute
Department

Funding Source
Organization	Dept. of Anesthesiology, Kyorin University, School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	IRB, Kyorin University, School of Medicine
Address	6-20-2 Shinkawa Mitaka City, Tokyo
Tel	0422475511
Email	rec@ks.kyorin-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	杏林大学医学部付属病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 06 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	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 06 Day
Date of IRB	2017 Year 02 Month 06 Day
Anticipated trial start date	2017 Year 02 Month 06 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation data are patients' background, risk factors for central venous insertion, insertion attempts, select of central veins for insertion, doctors' licences of central insertion depending on the clinical experiences and whether an ultrasound devices are uses or not.

Management information
Registered date	2017 Year 02 Month 05 Day
Last modified on	2020 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029897