UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026165 |
|---|---|
| Receipt number | R000030065 |
| Scientific Title | An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial). |
| Date of disclosure of the study information | 2017/02/16 |
| Last modified on | 2019/02/18 12:11:59 |
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Basic information
Public title
An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).
Acronym
An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).
Scientific Title
An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Atsushi Fukumoto |
Organization
Rakuwakai Otowa Hospital
Division name
Department of Cardiothoracic surgery
Zip code
Address
2 Otowach, Chinji-cho, Yamashina-ku, Kyoto, Japan
TEL
81-75-593-4111
fukumotoatsushi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Takeshita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL
81-75-641-9161
Homepage URL
t-k-s-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Rakuwakai Otowa Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jcvaonline.com/article/S1053-0770(18)30610-4/fulltext
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
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 09 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030065
