UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026005 |
|---|---|
| Receipt number | R000029897 |
| Scientific Title | Investigation of prominent factors and preventive mesasures of mechanical complication of central venous catheter insertion |
| Date of disclosure of the study information | 2017/02/06 |
| Last modified on | 2020/09/11 16:42:39 |
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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
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/
kyorinanesth@gmail.com
Sponsor or person
Institute
Dept. of Anesthesiology, Kyorin University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029897
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
