Jugular Venous FlowNCT02002507
Jugular Venous Flow Neurosurgical Patients
An observational study of Jugular Venous 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 between the right and left internal jugular veins in the park bench position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jugular Venous Flow
- What is being tested?
- comparison of different neurosurgical position
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to 31 Dec 2019
- 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: Neurosurgical patients in either park bench or prone position for their surgery
Who may be able to join
- Adult neurosurgical patients who are above the age of 18
- Patients undergoing neurosurgery requiring general anesthesia and placement in either in prone or park bench position for surgical accessibility
Who cannot join
- Lack of informed consent
- Patients undergoing surgical procedures only in the supine position
- Patients needing a central venous catheter in the neck
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 Neurosurgical Patients
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 between the right and left internal jugular veins in the park bench position. In particular, 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 positions.
Read the detailed description
The different positions used in neurosurgery for better accessibility to the operating field (park bench, prone) can impact cerebral venous drainage due to the effects of internal jugular venous outflow of blood, and may increase intracranial pressure. Excessive neck flexion and rotation in the park bench position, or flexion in the prone position, may lead to kinking or twisting of the internal jugular vein. This has been hypothesized as the major cause of disturbed venous drainage during surgery and may lead to neck swelling, brachial plexus injury, macroglossia (swollen tongue), delayed airway obstruction, and increases in intracranial pressure in postoperative patients. Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed in this position. Thus, we look to measure the internal jugular venous flow at different positions, as there have been few studies looking at this important contributing factor.
- Conditions
- Jugular Venous Flow
- Being tested
- comparison of different neurosurgical position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of different neurosurgical positionOther
in 2 of 3 positions (supine, plus either prone or park bench) with both left and right internal jugular vein cross-sectional area of vein, doppler velocity, internal jugular venous flow, position of internal jugular vein in relation to carotid artery (All measured with the use of ultrasound)
| Study group | Role | What they receive |
|---|---|---|
| park bench position | Comparing jugular venous flow in supine and park bench position in neurosurgical patients requiring their surgery in park bench position Receives: Other: comparison of different neurosurgical position | |
| prone position | Comparing the jugular venous flow in the supine and prone position in patients requiring their surgery to be done in the prone position. Receives: Other: comparison of different neurosurgical position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jugular venous flow
One of the following will be compared depending on the position of the patient
- Bilateral internal jugular venous flow in supine and prone position
- Bilateral internal jugular venous flow in supine and park bench position
Measured: 1 day
Secondary outcomes (2)
cross- sectional area of internal jugular vein
Comparing the cross-sectional area of the internal jugular vein in different positions
Measured: 1 day
doppler velocity of jugular venous flow
Comparing the doppler velocity of jugular venous flow in different surgical positions in neurosurgical patients
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 startJan 2015
- Primary completion21 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: We faced technical problem before conducting this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jugular Venous 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
- 0 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 HospitalJigesh Mehta, Principal investigator, University Health Network, Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002507
- Sponsor's protocol ID
- 13-6432
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2013
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. 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 Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT02002507
- Acronym / sponsor ID
- 13-6432
- Conditions
- Jugular Venous Flow
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We faced technical problem before conducting this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 21 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Dec 2013 (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.
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 between the right and left internal jugular veins in the park bench position. In particular, 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 positions.
Detailed description
The different positions used in neurosurgery for better accessibility to the operating field (park bench, prone) can impact cerebral venous drainage due to the effects of internal jugular venous outflow of blood, and may increase intracranial pressure. Excessive neck flexion and rotation in the park bench position, or flexion in the prone position, may lead to kinking or twisting of the internal jugular vein. This has been hypothesized as the major cause of disturbed venous drainage during surgery and may lead to neck swelling, brachial plexus injury, macroglossia (swollen tongue), delayed airway obstruction, and increases in intracranial pressure in postoperative patients. Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed in this position. Thus, we look to measure the internal jugular venous flow at different positions, as there have been few studies looking at this important contributing factor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| park bench position | – | Other: comparison of different neurosurgical positionComparing jugular venous flow in supine and park bench position in neurosurgical patients requiring their surgery in park bench position |
| prone position | – | Other: comparison of different neurosurgical positionComparing the jugular venous flow in the supine and prone position in patients requiring their surgery to be done in the prone position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurosurgical patients in either park bench or prone position for their surgery
Key inclusion criteria (2 listed)
- Adult neurosurgical patients who are above the age of 18
- Patients undergoing neurosurgery requiring general anesthesia and placement in either in prone or park bench position for surgical accessibility
Key exclusion criteria (3 listed)
- Lack of informed consent
- Patients undergoing surgical procedures only in the supine position
- Patients needing a central venous catheter in the neck
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 |
|---|---|---|
| comparison of different neurosurgical positionin 2 of 3 positions (supine, plus either prone or park bench) with both left and right internal jugular vein cross-sectional area of vein, doppler velocity, internal jugular venous flow, position of internal jugular vein in relation to carotid artery (All measured with the use of ultrasound) | Other | park bench position, prone position |
Primary outcome
Jugular venous flow
Time frame: 1 day
One of the following will be compared depending on the position of the patient * Bilateral internal jugular venous flow in supine and prone position * Bilateral internal jugular venous flow in supine and park bench position
2 secondary outcomes
cross- sectional area of internal jugular vein
Time frame: 1 day
doppler velocity of jugular venous flow
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
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 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Dec 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Jugular venous flow (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 22 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.