Internal Jugular Vein Flow in the Sitting Position

• Sponsor: Lashmi Venkatraghavan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02356887
• Collaborator: University Health Network, Toronto (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Jugular Venous Flow	Diagnostic Test: Jugular venous ultrasound	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Measurement of Flow in Internal Jugular Vein in the Sitting Position: an Ultrasound Study on Healthy Volunteers
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: sitting position The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points. The second scanning point was along the IJV at the highest accessible point on the neck. Internal jugular vein cross-sectional area and blood velocity were measured using 2D ultrasound and Doppler (Philips CX50, Andover, MA, USA), respectively, with a 12-3 MHz transducer (Philips L12-3, Andover, MA, USA)

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.

Outcome Measures

Primary Outcome Measures

1. Internal Jugular Venous Flow [1 day]

   Right Internal Jugular Vein Flow in the sitting position.

2. Left Internal Jugular Vein Flow [1 day]

   left internal jugular vein cross-sectional area in the sitting position at rest and with application of the cervical collar.

3. Right Internal Jugular Vein Flow in the Sitting Position [one day]

   Right internal jugular vein peak velocity in the sitting position at rest and with application of the cervical collar

4. Right Internal Jugular [one day]

   Comparisons of right internal jugular vein flow in the sitting position at rest and with application of the cervical collar

Secondary Outcome Measures

1. Left Internal Jugular Vein Flow in the Sitting Position [One day]

   Comparisons of left internal jugular vein peak velocity in the sitting position at rest and with application of the cervical collar

2. Left Internal flow in the Sitting Position [One day]

   left internal jugular vein flow in the sitting position at rest and with application of the cervical collar

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada	M5T2S8

Sponsors and Collaborators

• Lashmi Venkatraghavan
• University Health Network, Toronto

Investigators

• Principal Investigator: Lashmi Venkatraghavan, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lashmi Venkatraghavan, Assistant Professor, Department of Anesthesia, Toronto Western Hospital, Toronto, Canada, University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT02356887
• Other Study ID Numbers: UHN REB # 14-8319
• First Posted: Feb 5, 2015
• Last Update Posted: Aug 7, 2020
• Last Verified: Aug 1, 2020

Study Results

Participant Flow

Arm/Group Title	Internal Jugular Vein Flow in the Sitting Position
Arm/Group Description	The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
Period Title: Overall Study
STARTED	12
COMPLETED	10
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Sitting Position
Arm/Group Description	The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 83.3%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	2 16.7%
Male	8 66.7%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Internal Jugular Venous Flow
Description	Right Internal Jugular Vein Flow in the sitting position.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Arm/Group Title	Right IJV at Rest	Right IJV With Collar
Arm/Group Description	Venous Jugular Flow in the Sitting Position at rest on right Internal Jugular Venous	Venous Jugular Flow in the Sitting Position with collar on right Internal Jugular Venous
Measure Participants	10	10
Cross-sectional area at C6	0.04	0.4
High cross-sectional area	0.04	0.21

2. Primary Outcome

Title	Left Internal Jugular Vein Flow
Description	left internal jugular vein cross-sectional area in the sitting position at rest and with application of the cervical collar.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Arm/Group Title	Left IJV at Rest	Left IJV With Collar
Arm/Group Description	Venous Jugular Flow in the Sitting Position at rest on left Internal Jugular Venous	Venous Jugular Flow in the Sitting Position with collar on left Internal Jugular Venous
Measure Participants	10	10
Cross-sectional area at C6	0.07	0.35
High cross-sectional area	0.05	0.13

3. Primary Outcome

Title	Right Internal Jugular Vein Flow in the Sitting Position
Description	Right internal jugular vein peak velocity in the sitting position at rest and with application of the cervical collar
Time Frame	one day

Outcome Measure Data

Analysis Population Description

Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Arm/Group Title	Right Internal Jugular Vein in the Sitting Position at Rest	Right Internal Jugular Vein in the Sitting Position Collar
Arm/Group Description	The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points	The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
Measure Participants	12	12
Median (Inter-Quartile Range) [cm.sec-1]	70	17

4. Primary Outcome

Title	Right Internal Jugular
Description	Comparisons of right internal jugular vein flow in the sitting position at rest and with application of the cervical collar
Time Frame	one day

Outcome Measure Data

Analysis Population Description

Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Arm/Group Title	Right Internal Jugular Vein in the Sitting Position at Rest	Right Internal Jugular Vein in the Sitting Position Collar
Arm/Group Description	The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points	Comparisons of bilateral internal jugular vein cross-sectional area, peak velocity, and flow in the sitting position at rest and with application of the cervical collar
Measure Participants	10	10
Flow at C6	193	349
Flow at high cross-sectional area	121	236

5. Secondary Outcome

Title	Left Internal Jugular Vein Flow in the Sitting Position
Description	Comparisons of left internal jugular vein peak velocity in the sitting position at rest and with application of the cervical collar
Time Frame	One day

Outcome Measure Data

Analysis Population Description

Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Arm/Group Title	Left IJV at Rest	Left IJV With Collar
Arm/Group Description	Venous Jugular Flow in the Sitting Position at rest on left Internal Jugular Venous	Venous Jugular Flow in the Sitting Position with collar on left Internal Jugular Venous
Measure Participants	10	10
Median (Inter-Quartile Range) [cm.sec-1]	30	12

6. Secondary Outcome

Title	Left Internal flow in the Sitting Position
Description	left internal jugular vein flow in the sitting position at rest and with application of the cervical collar
Time Frame	One day

Outcome Measure Data

Analysis Population Description

Data analyzed for only 10 participants who completed the study, two participants were excluded from the study due to poor compliance.

Arm/Group Title	Left IJV at Rest	Left IJV With Collar
Arm/Group Description	Venous Jugular Flow in the Sitting Position at rest on left Internal Jugular Venous	Venous Jugular Flow in the Sitting Position with collar on left Internal Jugular Venous
Measure Participants	10	10
Flow at C6	113	183
Flow at high cross-sectional area	105	889

Adverse Events

Time Frame	1 day
Adverse Event Reporting Description	Any adverse events detected during the procedure
Arm/Group Title	Internal Jugular Venous Flow in Sitting Position
Arm/Group Description	The volunteers were kept comfortable in the sitting position. The cricoid cartilage (representing the C6 level) was used as a landmark. A horizontal straight line drawn across the volunteer's neck at the cricoid level and intersecting the IJV on both sides of the neck marked the initial scanning points
All Cause Mortality
	Internal Jugular Venous Flow in Sitting Position
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Internal Jugular Venous Flow in Sitting Position
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Internal Jugular Venous Flow in Sitting Position
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.