- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02002507
Jugular Venous Flow Neurosurgical Patients
December 20, 2022 updated by: Lashmi Venkatraghavan, University Health Network, Toronto
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 2S8
- University Health Network, Toronto Western Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neurosurgical patients in either park bench or prone position for their surgery
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Lack of informed consent
- Patients undergoing surgical procedures only in the supine position
- Patients needing a central venous catheter in the neck
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
park bench position
Comparing jugular venous flow in supine and park bench position in neurosurgical patients requiring their surgery in park bench position
|
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)
|
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.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Jugular venous flow
Time Frame: 1 day
|
One of the following will be compared depending on the position of the patient
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cross- sectional area of internal jugular vein
Time Frame: 1 day
|
Comparing the cross-sectional area of the internal jugular vein in different positions
|
1 day
|
doppler velocity of jugular venous flow
Time Frame: 1 day
|
Comparing the doppler velocity of jugular venous flow in different surgical positions in neurosurgical patients
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lashmi Venkatraghavan, University Health Network, Toronto Western Hospital
- Principal Investigator: Vincent Chan, University Health Network, Toronto Western Hospital
- Principal Investigator: Pirjo Manninen, University Health Network, Toronto Western Hospital
- Principal Investigator: Audrey MY Tan, University Health Network, Toronto Western Hospital
- Principal Investigator: Jigesh Mehta, University Health Network, Toronto Western Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Anticipated)
November 21, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
November 29, 2013
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 5, 2013
Study Record Updates
Last Update Posted (Actual)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 20, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 13-6432
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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