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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
park bench position
Comparing jugular venous flow in supine and park bench position in neurosurgical patients requiring their surgery in park bench position
Other: comparison of different neurosurgical 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.
Other: comparison of different neurosurgical 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

  • Bilateral internal jugular venous flow in supine and prone position
  • Bilateral internal jugular venous flow in supine and park bench position
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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