Internal Jugular Size Measured by UltrasoundNCT00904358
Estimation of Internal Jugular Vein Central Venous Pressure (CVP) by Ultrasound
An observational study of Internal Jugular Size Measured by Ultrasound and Central Venous Pressure, run by Mahidol University at 2 sites in Thailand.
Trial summary
To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Jugular Size Measured by Ultrasound, Central Venous Pressure
- What is being tested?
- cross sectional area
- How many people
- 130 participants
- Where
- 2 sitesThailand
- Study dates
- May 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for cardiac surgery in Siriraj Hospital
Who may be able to join
- patients scheduled for cardiac surgery
- need central venous catheterization intraoperatively
- elective surgery
- age > 18
Who cannot join
- neck pathology
- history of internal jugular or SVC thrombosis
- limited neck mobility
- severe valvular lesion
- decompensated heart failure
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of Medicine, Siriraj Hospital
Bangkok, 10700
Kasana Raksamani
Bangkok, 10700
About this study
Official title: Validity and Reliability of Non-invasive Estimation of Central Venous Pressure by Measurement of Internal Jugular Size Using 2-dimensional Ultrasound
To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.
Read the detailed description
Objectives:
- To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.
- To evaluate the correlation of internal jugular vein cross sectional area and central venous pressure.
Methods:
- The study design is prospective observational study.
- We will include all patients scheduled for cardiac surgery in Siriraj Hospital and record both internal jugular size using 2-dimensional ultrasound just before central venous catheter insertion. The central venous pressure will be recorded and the ultrasound picture will be measured.
- The data will be analyzed.
- Being tested
- cross sectional area
- Keywords
- internal jugular vein, cross sectional area, ultrasound, central venous pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross sectional areaDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| cross sectional area | internal jugular cross sectional area measured by ultrasound Receives: Diagnostic Test: cross sectional area |
What is being measured
The primary outcome is the main question the study is designed to answer.
internal jugular size
Cross-sectional area of internal jugular vein measured by ultrasound
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Jugular Size Measured by UltrasoundStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kasana Raksamani, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904358
- Sponsor's protocol ID
- Si183/2009
- Status last verified
- Jun 2017
- First submitted
- 15 May 2009
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Non-invasive Estimation of Central Venous Pressure by Measurement of Internal Jugular Size Using 2-dimensional Ultrasound
- ClinicalTrials.gov ID
- NCT00904358
- Acronym / sponsor ID
- Si183/2009
- Keywords
- internal jugular vein, cross sectional area, ultrasound, central venous pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.
Detailed description
Objectives:
- To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.
- To evaluate the correlation of internal jugular vein cross sectional area and central venous pressure.
Methods:
- The study design is prospective observational study.
- We will include all patients scheduled for cardiac surgery in Siriraj Hospital and record both internal jugular size using 2-dimensional ultrasound just before central venous catheter insertion. The central venous pressure will be recorded and the ultrasound picture will be measured.
- The data will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cross sectional area | – | Diagnostic Test: cross sectional areainternal jugular cross sectional area measured by ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for cardiac surgery in Siriraj Hospital
Key inclusion criteria (4 listed)
- patients scheduled for cardiac surgery
- need central venous catheterization intraoperatively
- elective surgery
- age > 18
Key exclusion criteria (5 listed)
- neck pathology
- history of internal jugular or SVC thrombosis
- limited neck mobility
- severe valvular lesion
- decompensated heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cross sectional area | Diagnostic test | cross sectional area |
Primary outcome
internal jugular size
Time frame: 1 day
Cross-sectional area of internal jugular vein measured by ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasana Raksamani, MD principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Jugular Size Measured by Ultrasound and Central Venous Pressure, run by Mahidol University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
internal jugular size (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.