UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054649 |
|---|---|
| Receipt number | R000062447 |
| Scientific Title | Verification of the effect of internal jugular vein dilation by the proximal compression method of the echo probe |
| Date of disclosure of the study information | 2024/06/14 |
| Last modified on | 2025/06/13 20:18:11 |
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Basic information
Public title
Verification of the effect of internal jugular vein dilation by the proximal compression method of the echo probe
Acronym
Verification of the effect of internal jugular vein dilation by the proximal compression method of the echo probe
Scientific Title
Verification of the effect of internal jugular vein dilation by the proximal compression method of the echo probe
Scientific Title:Acronym
Verification of the effect of internal jugular vein dilation by the proximal compression method of the echo probe
Region
| Japan |
Condition
Condition
Patients who are not intubated and whose internal jugular vein can be examined by echocardiography
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The proximal portion of the internal jugular vein is compressed with an echo probe to measure the vessel diameter and cross-sectional area at the distal portion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change in internal jugular vein diameter and cross-sectional area due to proximal internal jugular vein compression is examined.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-intubated patients 18 years of age or older admitted to the emergency room, ICU, or HCU whose internal jugular vein can be evaluated during an echocardiographic evaluation performed as part of routine medical care.
Key exclusion criteria
Pediatric cases, intubated cases, cases requiring urgent treatment, cases in which internal jugular vein echo cannot be performed, and cases in which consent could not be obtained.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | MASATAKA |
| Middle name | |
| Last name | HIRUMA |
Organization
Niigata University Medical & Dental Hospital
Division name
Intensive Care Unit
Zip code
951-8520
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-223-6161
masarabi62@yahoo.co.jp
Public contact
Name of contact person
| 1st name | MASATAKA |
| Middle name | |
| Last name | HIRUMA |
Organization
Niigata University Medical & Dental Hospital
Division name
Intensive Care Unit
Zip code
951-8520
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-223-6161
Homepage URL
masarabi62@yahoo.co.jp
Sponsor or person
Institute
Niigata University Medical & Dental Hospital
Institute
Department
Personal name
MASATAKA HIRUMA
Funding Source
Organization
self-financing
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
Ethics Review Board for Research Involving Human Subjects
Address
754 Asahimachidori Ichibancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-227-2625
ethics@adm.niigata-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 14 | 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
25
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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Two echo machines (Echo A and B) are used. The patient is positioned supine with the bed inclined at 0 degrees. With the patient's head rotated 30 degrees to the right, a linear probe is applied to the right internal jugular vein using Echo A. The short and long diameters and cross-sectional area are measured and recorded. With Echo B, a linear probe is placed proximal to the internal jugular vein (just above the clavicle) to compress the vein and occlude it on the screen. The short and long diameters and cross-sectional area are recorded again using Echo A. The short and long diameters and the cross-sectional area before and after compression are compared based on the recordings.
Management information
Registered date
| 2024 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062447
