Jugular Venous Blood FlowNCT02002494
Jugular Venous Flow Healthy Volunteers
An observational study of Jugular Venous Blood Flow, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Our hypothesis is that there will be a decrease in internal jugular venous flow in the park bench position when compared to the supine position. There will also be a change in blood flow in the between right and left internal jugular veins in park bench position, particularly there will be a greater reduction of flow… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jugular Venous Blood Flow
- What is being tested?
- Different positions
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Feb 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- Adult healthy volunteers who are above the age of 18
- American Society of Anesthesiologists classification (ASA) 1
- Body mass index (BMI) less than and equal to 35
Who cannot join
- ASA 2 and above
- BMI above 35
- Lack of informed consent
- Language barrier
- Medical students and anaesthesia residents going through the department as part of their rotation
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: Effect of Different Surgical Positions on the Cerebral Venous Drainage: an Ultrasound Study on Healthy Volunteers
Our hypothesis is that there will be a decrease in internal jugular venous flow in the park bench position when compared to the supine position. There will also be a change in blood flow in the between right and left internal jugular veins in park bench position, particularly there will be a greater reduction of flow on the dependent side. However, the internal jugular venous flow will be the same in both the prone and supine position.
Read the detailed description
The different positions used in neurosurgery (park bench, prone) for better accessibility to the operating field can impact on the cerebral venous drainage due to the effects of internal jugular venous outflow of blood and may increase intracranial pressure. The kinking of the internal jugular vein due to excessive neck flexion and rotation in park bench or flexion in the prone position may lead to kinking or twisting of the vein. This has been hypothesized as the major cause of disturbed venous drainage during surgery and in postoperative patients may lead to neck swelling, brachial plexus injury, macroglossia (swollen tongue), delayed airway obstruction and increases in intracranial pressure.
Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed with this. Thus, we look to measure the internal jugular venous flow at different positions as there have been little studies looking at this important contributing factor.
- Conditions
- Jugular Venous Blood Flow
- Being tested
- Different positions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different positionsOther
Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench
| Study group | Role | What they receive |
|---|---|---|
| volunteers in different positions | The following will be compared in the same volunteer:
* Bilateral internal jugular venous flow in supine and prone position
* Bilateral internal jugular venous flow in supine and park bench position
* Bilateral internal jugular venous flow in prone and park bench Receives: Other: Different positions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Jugular Venous (IJV) Cross Sectional Area
Comparisons of both jugular vein (IJV) of twenty-seven volunteers in supine and prone positions.
Measured: 1 day
Right and Left IJV Cross Sectional Area
Twenty-seven volunteers were included in this study. Comparisons of cross sectional area measurements in both IJVs between supine and right park bench
Measured: 1 day
Internal Jugular Venous (IJV) Doppler Velocity
27 volunteers enrolled to measure the Internal Jugular Venous (IJV) in supine and prone positions
Measured: 1 day
Bilateral Internal Jugular Vein (IJV) Flow
Comparisons of bilateral internal jugular vein (IJV) flow between supine and prone position. Data presented as mean (SD) .
Measured: 1 day
Bilateral Internal Jugular Vein (IJV) Doppler Velocity
Comparisons of bilateral internal jugular vein (IJV) Doppler velocity between supine and right park bench position.
Measured: 1 day
R IJV and L IJV Flow
Bilateral internal jugular vein (IJV) flow between supine and right park bench position.
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 posted5 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Jugular Venous Blood FlowStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lashmi Venkatraghavan, University Health Network, Toronto
- Investigators
- Lashmi Venkatraghavan, Principal investigator, University Health Network, Toronto Western HospitalVincent Chan, Principal investigator, University Health Network, Toronto Western HospitalPirjo Manninen, Principal investigator, University Health Network, Toronto Western HospitalAudrey MY Tan, Principal investigator, University Health Network, Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002494
- Sponsor's protocol ID
- 13-6244-BE
- Status last verified
- May 2020
- First submitted
- 29 Nov 2013
- Last updated
- 4 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Surgical Positions on the Cerebral Venous Drainage: an Ultrasound Study on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02002494
- Acronym / sponsor ID
- 13-6244-BE
- Conditions
- Jugular Venous Blood Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Posted 4 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our hypothesis is that there will be a decrease in internal jugular venous flow in the park bench position when compared to the supine position. There will also be a change in blood flow in the between right and left internal jugular veins in park bench position, particularly there will be a greater reduction of flow on the dependent side. However, the internal jugular venous flow will be the same in both the prone and supine position.
Detailed description
The different positions used in neurosurgery (park bench, prone) for better accessibility to the operating field can impact on the cerebral venous drainage due to the effects of internal jugular venous outflow of blood and may increase intracranial pressure. The kinking of the internal jugular vein due to excessive neck flexion and rotation in park bench or flexion in the prone position may lead to kinking or twisting of the vein. This has been hypothesized as the major cause of disturbed venous drainage during surgery and in postoperative patients may lead to neck swelling, brachial plexus injury, macroglossia (swollen tongue), delayed airway obstruction and increases in intracranial pressure.
Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed with this. Thus, we look to measure the internal jugular venous flow at different positions as there have been little studies looking at this important contributing factor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers in different positions | – | Other: Different positionsThe following will be compared in the same volunteer: * Bilateral internal jugular venous flow in supine and prone position * Bilateral internal jugular venous flow in supine and park bench position * Bilateral internal jugular venous flow in prone and park bench |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (3 listed)
- Adult healthy volunteers who are above the age of 18
- American Society of Anesthesiologists classification (ASA) 1
- Body mass index (BMI) less than and equal to 35
Key exclusion criteria (5 listed)
- ASA 2 and above
- BMI above 35
- Lack of informed consent
- Language barrier
- Medical students and anaesthesia residents going through the department as part of their rotation
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 |
|---|---|---|
| Different positionsJugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench | Other | volunteers in different positions |
Primary outcome
Internal Jugular Venous (IJV) Cross Sectional Area
Time frame: 1 day
Comparisons of both jugular vein (IJV) of twenty-seven volunteers in supine and prone positions.
Right and Left IJV Cross Sectional Area
Time frame: 1 day
Twenty-seven volunteers were included in this study. Comparisons of cross sectional area measurements in both IJVs between supine and right park bench
Internal Jugular Venous (IJV) Doppler Velocity
Time frame: 1 day
27 volunteers enrolled to measure the Internal Jugular Venous (IJV) in supine and prone positions
Bilateral Internal Jugular Vein (IJV) Flow
Time frame: 1 day
Comparisons of bilateral internal jugular vein (IJV) flow between supine and prone position. Data presented as mean (SD) .
Bilateral Internal Jugular Vein (IJV) Doppler Velocity
Time frame: 1 day
Comparisons of bilateral internal jugular vein (IJV) Doppler velocity between supine and right park bench position.
R IJV and L IJV Flow
Time frame: 1 day
Bilateral internal jugular vein (IJV) flow between supine and right park bench position.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Jugular Venous Blood Flow
Not yet recruitingObservational study
Effect of Internal Jugular Vein Catheterization on Intracranial Pressure and Intracranial Blood Flow
Intracranial Pressure, Ultrasonography
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.
Lashmi Venkatraghavan principal investigator
University Health Network, Toronto Western Hospital
Vincent Chan principal investigator
University Health Network, Toronto Western Hospital
Pirjo Manninen principal investigator
University Health Network, Toronto Western Hospital
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 Jugular Venous Blood Flow, run by University Health Network, Toronto at 1 site in Canada.
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 3 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 4 Jun 2020. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Venous (IJV) Cross Sectional Area (time frame: 1 day). The study lists 6 primary outcomes in all. 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 4 Jun 2020.