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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02356887
Other study ID # 14-8319
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date September 2015

Study information

Verified date December 2022
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During neurosurgical procedures, patients need to be placed in sitting position for surgical access especially in surgeries in the vertex or posterior fossa. Due gravitational effect of sitting position the flow in IJV may be reduced. Venous air embolism (VAE) is a common complication of sitting position craniotomy and carries high mortality and morbidity. Venous pressure decreases as the head of the patient is raised above the heart. Hence, negative venous pressure in the cerebral venous system promotes entrapment of air in accidental opening of the sinuses. Common methods to prevent VAE in sitting position include increasing the venous pressure by either jugular venous compression and/or increasing the venous pressure by adding positive end expiratory pressure (PEEP). Both these methods can decrease venous return and can lead to brain swelling.. In addition, improper neck position can cause the kinking of the IJV which may lead to decreased venous drainage and increased ICP. This has been shown to be the contributing factor for intraoperative brain swelling and postoperative neck and tongue swelling leading to airway obstruction. Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed with this.


Description:

Currently, there are no studies that looked into the IJV flow in sitting position and effect of venous outflow obstruction on the IJV flow. Valsalva maneuver (forced inspiration with closed glottis) and /or compression of internal jugular veins (IJV) are the two commonly used physiological methods that can cause venous outflow obstruction. A custom made neck collar can be used for compression of internal jugular vein and previous investigations have used a similar device in a rat model to demonstrate the protective effects on slosh-mediated brain injury by increasing intracranial blood volume . While the collars have not yet been studied on people for their effectiveness at preventing concussions, many studies have looked at the effect of neck collars on both jugular compression and ICP.. The purpose of this study is to measure the venous blood flow of healthy volunteers by the use of an ultrasound and Doppler velocimetry in sitting position. the investigators will measure the IJV flow on both sides in sitting position at rest and at two conditions of venous outflow obstruction- 1. Neck compression using a custom made collar and 2. During 30 seconds Valsalva maneuver. This study will provide information on the cerebral venous drainage. This information will be very useful in planning and positioning of patients undergoing neurosurgical procedures and to prevent complications from the improper patient position.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult healthy volunteers who are above the age of 18 ASA 1 - Body mass index (BMI) less than and equal to 35 Exclusion Criteria: - Lack of informed consent - Language barrier - Medical students and anesthesia residents going through the department as part of their rotation

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Jugular venous ultrasound
All volunteers will be fully awake throughout the study and be kept comfortable. A cross will be marked where the left and right IJV cross the level of C6. This is where all the measurements will be taken in 3 different conditions at rest, jugular occlusion and valsalva maneuver. At each conditions, the left and right IJV will be scanned with an ultrasound measuring the cross sectional area and Doppler velocity of the IJV. The least amount of pressure will be used to press on the ultrasound probe and the measurements will be obtained at end inspiration. The IJV flow is then calculated.

Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Lashmi Venkatraghavan University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Internal Jugular Venous Flow Right Internal Jugular Vein Flow in the sitting position. 1 day
Primary Left Internal Jugular Vein Flow left internal jugular vein cross-sectional area in the sitting position at rest and with application of the cervical collar. 1 day
Primary Right Internal Jugular Vein Flow in the Sitting Position Right internal jugular vein peak velocity in the sitting position at rest and with application of the cervical collar one day
Primary Right Internal Jugular Comparisons of right internal jugular vein ?ow in the sitting position at rest and with application of the cervical collar one day
Secondary Left Internal Jugular Vein Flow in the Sitting Position Comparisons of left internal jugular vein peak velocity in the sitting position at rest and with application of the cervical collar One day
Secondary Left Internal ?ow in the Sitting Position left internal jugular vein ?ow in the sitting position at rest and with application of the cervical collar One day
See also
  Status Clinical Trial Phase
Withdrawn NCT02002507 - Jugular Venous Flow Neurosurgical Patients