UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047583 |
|---|---|
| Receipt number | R000054262 |
| Scientific Title | Effect of puncture point on success rate in central venous catheterization of internal jugular vein under ultrasound guidance |
| Date of disclosure of the study information | 2023/05/23 |
| Last modified on | 2022/04/25 13:53:53 |
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Basic information
Public title
Effect of puncture point on success rate in central venous catheterization of internal jugular vein under ultrasound guidance
Acronym
EPPOSC
Scientific Title
Effect of puncture point on success rate in central venous catheterization of internal jugular vein under ultrasound guidance
Scientific Title:Acronym
EPPOSC
Region
| Asia(except Japan) |
Condition
Condition
Internal jugular catheterization
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the success rates of needle puncture from the medial third of the internal jugular vein and central puncture in ultrasound-guided central venous catheterization of the internal jugular vein.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Probability of successful guide-wire placement without complications in the first attempt
Key secondary outcomes
Total number of needle punctures, total success rate, time required from skin puncture to guide-wire insertion, and complication rate (vascular puncture, arterial puncture, pneumothorax, hematoma)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
When performing central venous catheterization in the internal jugular vein, puncture is performed at medial of the transverse diameter.
Interventions/Control_2
When performing central venous catheterization in the internal jugular vein, puncture is performed at 1/3 of the medial of the transverse diameter.
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
| 19 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A.American Society of Anesthesiologist Classification 1 to 4 patients
B. Adults 19 years of age or older
C. Patient planning for central venous catheterization under general anesthesia
D. Patients with informed consent to study
Key exclusion criteria
A. Patients with a history of internal jugular vein surgery
B. Patients who have a a central venous catheter at internal jugular vein
C. Patients with hematoma and infection at the insertion point for central venous catheterization
D. Patients with anatomical abnormalities at the insertion point for central venous catheterization
E. Patients whose blood levels related to coagulation are not normalized (PT INR > 2.0 sec, PLT < 50,000/ul)
F. Emergency Surgery
G. Pregnant women
Target sample size
162
Research contact person
Name of lead principal investigator
| 1st name | Jin-Hee |
| Middle name | |
| Last name | KIM |
Organization
Seoul national uiversity Bundang Hospital
Division name
Anesthesiology and pain medicine
Zip code
13620
Address
82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL
+82317877499
anesing1@snu.ac.kr
Public contact
Name of contact person
| 1st name | Jiyoun |
| Middle name | |
| Last name | LEE |
Organization
Seoul national university Bundang hospital
Division name
Anesthesiology and pain medicine
Zip code
13620
Address
82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL
+82317873640
Homepage URL
heykiki1@hanmail.net
Sponsor or person
Institute
Seoul national university Bundang hospital
Institute
Department
Personal name
Funding Source
Organization
KCPMED
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Republic of Korea
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul national university Bundang hospital
Address
172 Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Tel
+82317878801
snubhirb@gmail.com
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
Seoul national university Bundang hospital(Seong-nam)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054262
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| Registered date | File name |
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