Comparison of the Right and Left Internal Jugular Vein Using UltrasoundNCT01599299
Comparison of the Right and Left Internal Jugular Vein Using Ultrasound
An observational study of Comparison of the Right and Left Internal Jugular Vein Using Ultrasound, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether there is a difference between the diameter, and the cross-sectional area of the right internal in left internal jugular vein in preoperative, mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comparison of the Right and Left Internal Jugular Vein Using Ultrasound
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Jul 2012
- 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: All patients who will need a central venous access (into the right jugular vein) preoperative are included
Who may be able to join
- all patients who will need a central venous access preoperative are included (e.g. for medication, nutrition, antibiotics)and are mechanically ventilated
Who cannot join
- < 18 years of age
- neck or head surgery in the past
- radiation therapy of the neck
- known thyroid pathology
- skeletal deformities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Diameter, Cross-sectional Area and Position of the Left and Right Internal Jugular Vein in Adults Using Ultrasound
The purpose of this study is to determine whether there is a difference between the diameter, and the cross-sectional area of the right internal in left internal jugular vein in preoperative, mechanically ventilated patients.
Secondary the relationship between the internal jugular vein to the common carotid artery will be examined.
Read the detailed description
Placement of a central venous catheter (CVC) for surgery is used for hemodynamic monitoring and venous access. Most often the right internal jugular vein (RIJV) is used. The RIJV is preferred over the left-sided internal jugular vein (LIJV) because cannulation of the LIJV is more difficult and associated with a higher complication rate(1). A possible explanation for the higher complication rate can be explained by the difference in diameter between the RIJV and the LIJV. It has been demonstrated that large vessels are easier to catheterize than small ones.
Data suggest that the internal jugular veins are most often asymmetric but data are limited. Until now, there is one small prospective study in which 80 ICU patients where examined (30 patients were mechanically ventilated) which showed an asymmetry in 62,5% and a dominant RIJV in 68% and a smaller study performed by Lobato and colleagues in which 50 healthy patients were examined. They measured the cross-sectional areas of the internal jugular veins. They showed that in 80% the RIJV was greater than the LIJV. Two CT studies has been done so far. In 2009 Tartière and colleagues carried out an observational study in 190 patients. All patients were in the supine position, neutral head position an spontaneous breathing. During the CT patients were asked to hold there breath. The study showed that the diameter and cross-sectional area of the RIJV were significantly greater than those of the LIJV. A smaller retrospective CT-study (88 patients) performed by Lim et al in 2006 showed a larger RIJV in 79,5% compared to the LIJV.
Until now, there are no data known about the difference between the RIJV and LIJV in preoperative mechanical ventilated patients when ultrasound is used.
- Keywords
- ultrasound, left and right jugular vein, comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound, internal jugular vein | All patients who will need a central venous access (into the right jugular vein) preoperative are included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the diameter, cross-sectional area and position of the left and right internal jugular vein in adults using ultrasound
Comparison of the cross-sectional area and diameter of the left internal jugular vein and the right internal jugular vein
Measured: Measurements are made after the patient is intubated and ventilated, prior to the surgical procedure starts.
Secondary outcomes (1)
Comparison of the diameter, cross-sectional area and position of the left and right internal jugular vein in adults using ultrasound
The localisation of the right/left internal jugular vein in relation to the carotid artery.
Measured: Measurements are made after the patient is intubated and ventilated, prior to the surgical procedure starts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of the Right and Left Internal Jugular Vein Using UltrasoundStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michiel Bos, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599299
- Sponsor's protocol ID
- 1.2.2012
- Status last verified
- Mar 2014
- First submitted
- 14 May 2012
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diameter, Cross-sectional Area and Position of the Left and Right Internal Jugular Vein in Adults Using Ultrasound
- ClinicalTrials.gov ID
- NCT01599299
- Acronym / sponsor ID
- 1.2.2012
- Keywords
- ultrasound, left and right jugular vein, comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 May 2012 (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.
The purpose of this study is to determine whether there is a difference between the diameter, and the cross-sectional area of the right internal in left internal jugular vein in preoperative, mechanically ventilated patients.
Secondary the relationship between the internal jugular vein to the common carotid artery will be examined.
Detailed description
Placement of a central venous catheter (CVC) for surgery is used for hemodynamic monitoring and venous access. Most often the right internal jugular vein (RIJV) is used. The RIJV is preferred over the left-sided internal jugular vein (LIJV) because cannulation of the LIJV is more difficult and associated with a higher complication rate(1). A possible explanation for the higher complication rate can be explained by the difference in diameter between the RIJV and the LIJV. It has been demonstrated that large vessels are easier to catheterize than small ones.
Data suggest that the internal jugular veins are most often asymmetric but data are limited. Until now, there is one small prospective study in which 80 ICU patients where examined (30 patients were mechanically ventilated) which showed an asymmetry in 62,5% and a dominant RIJV in 68% and a smaller study performed by Lobato and colleagues in which 50 healthy patients were examined. They measured the cross-sectional areas of the internal jugular veins. They showed that in 80% the RIJV was greater than the LIJV. Two CT studies has been done so far. In 2009 Tartière and colleagues carried out an observational study in 190 patients. All patients were in the supine position, neutral head position an spontaneous breathing. During the CT patients were asked to hold there breath. The study showed that the diameter and cross-sectional area of the RIJV were significantly greater than those of the LIJV. A smaller retrospective CT-study (88 patients) performed by Lim et al in 2006 showed a larger RIJV in 79,5% compared to the LIJV.
Until now, there are no data known about the difference between the RIJV and LIJV in preoperative mechanical ventilated patients when ultrasound is used.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound, internal jugular vein | – | –All patients who will need a central venous access (into the right jugular vein) preoperative are included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who will need a central venous access (into the right jugular vein) preoperative are included
Key inclusion criteria (1 listed)
- all patients who will need a central venous access preoperative are included (e.g. for medication, nutrition, antibiotics)and are mechanically ventilated
Key exclusion criteria (5 listed)
- < 18 years of age
- neck or head surgery in the past
- radiation therapy of the neck
- known thyroid pathology
- skeletal deformities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the diameter, cross-sectional area and position of the left and right internal jugular vein in adults using ultrasound
Time frame: Measurements are made after the patient is intubated and ventilated, prior to the surgical procedure starts.
Comparison of the cross-sectional area and diameter of the left internal jugular vein and the right internal jugular vein
1 secondary outcome
Comparison of the diameter, cross-sectional area and position of the left and right internal jugular vein in adults using ultrasound
Time frame: Measurements are made after the patient is intubated and ventilated, prior to the surgical procedure starts.
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 Mar 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparison of the Right and Left Internal Jugular Vein Using Ultrasound, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 1 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 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Comparison of the diameter, cross-sectional area and position of the left and right internal jugular vein in adults using ultrasound (time frame: Measurements are made after the patient is intubated and ventilated, prior to the surgical procedure starts.). 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 Mar 2014.