Jugular Venous Flow Healthy Volunteers

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT02002494
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief 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 in the between right and left internal jugular veins in park bench position, particularly 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 position.

Condition or Disease	Intervention/Treatment	Phase
Jugular Venous Blood Flow	Other: Different positions

Detailed Description

The different positions used in neurosurgery (park bench, prone) for better accessibility to the operating field can impact on the cerebral venous drainage due to the effects of internal jugular venous outflow of blood and may increase intracranial pressure. The kinking of the internal jugular vein due to excessive neck flexion and rotation in park bench or flexion in the prone position may lead to kinking or twisting of the vein. This has been hypothesized as the major cause of disturbed venous drainage during surgery and in postoperative patients may lead to neck swelling, brachial plexus injury, macroglossia (swollen tongue), delayed airway obstruction and increases in intracranial pressure.

Optimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed with this. Thus, we look to measure the internal jugular venous flow at different positions as there have been little studies looking at this important contributing factor.

Study Design

• Study Type: Observational
• Actual Enrollment: 27 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Different Surgical Positions on the Cerebral Venous Drainage: an Ultrasound Study on Healthy Volunteers
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
volunteers in different positions The following will be compared in the same volunteer: Bilateral internal jugular venous flow in supine and prone position Bilateral internal jugular venous flow in supine and park bench position Bilateral internal jugular venous flow in prone and park bench	Other: Different positions; Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench

Outcome Measures

Primary Outcome Measures

1. Internal Jugular Venous (IJV) Cross Sectional Area [1 day]

   Comparisons of both jugular vein (IJV) of twenty-seven volunteers in supine and prone positions.

2. Right and Left IJV Cross Sectional Area [1 day]

   Twenty-seven volunteers were included in this study. Comparisons of cross sectional area measurements in both IJVs between supine and right park bench

3. Internal Jugular Venous (IJV) Doppler Velocity [1 day]

   27 volunteers enrolled to measure the Internal Jugular Venous (IJV) in supine and prone positions

4. Bilateral Internal Jugular Vein (IJV) Flow [1 day]

   Comparisons of bilateral internal jugular vein (IJV) flow between supine and prone position. Data presented as mean (SD) .

5. Bilateral Internal Jugular Vein (IJV) Doppler Velocity [1 day]

   Comparisons of bilateral internal jugular vein (IJV) Doppler velocity between supine and right park bench position.

6. R IJV and L IJV Flow [1 day]

   Bilateral internal jugular vein (IJV) flow between supine and right park bench position.

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

• American Society of Anesthesiologists classification (ASA) 1

• Body mass index (BMI) less than and equal to 35

Exclusion Criteria:

• ASA 2 and above

• BMI above 35

• Lack of informed consent

• Language barrier

• Medical students and anaesthesia residents going through the department as part of their rotation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network, Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

• University Health Network, Toronto

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lashmi Venkatraghavan, Dr., University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT02002494
• Other Study ID Numbers: 13-6244-BE
• First Posted: Dec 5, 2013
• Last Update Posted: Jun 4, 2020
• Last Verified: May 1, 2020

Study Results

Participant Flow

Pre-assignment Detail	Twenty-seven volunteers were included in this study.

Arm/Group Title	Volunteers in Different Positions
Arm/Group Description	The following will be compared in the same volunteer: Bilateral internal jugular venous flow in supine and prone position Bilateral internal jugular venous flow in supine and park bench position Bilateral internal jugular venous flow in prone and park bench Different positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench
Period Title: Overall Study
STARTED	27
COMPLETED	27
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Volunteers in Different Positions
Arm/Group Description	The following will be compared in the same volunteer: Bilateral internal jugular venous flow in supine and prone position Bilateral internal jugular venous flow in supine and park bench position Bilateral internal jugular venous flow in prone and park bench Different positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench
Overall Participants	27
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38 (10)
Sex/Gender, Customized (participants) [Number]
Number [participants]	27 100%
Height (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	169.5 (12.5)
Weight (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	71.8 (15.4)

Outcome Measures

1. Primary Outcome

Title	Internal Jugular Venous (IJV) Cross Sectional Area
Description	Comparisons of both jugular vein (IJV) of twenty-seven volunteers in supine and prone positions.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Twenty-seven volunteers were included in this study. Comparisons of right and left internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and prone position.

Arm/Group Title	R IJV	L IJV
Arm/Group Description	Comparisons of right internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and prone position.	Comparisons of left internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and prone position.
Measure Participants	27	27
Supine-Cross sectional area	1.2 (0.6)	1.0 (0.3)
Prone-Cross sectional area	1.8 (1)	1.4 (0.4)

2. Primary Outcome

Title	Right and Left IJV Cross Sectional Area
Description	Twenty-seven volunteers were included in this study. Comparisons of cross sectional area measurements in both IJVs between supine and right park bench
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Comparisons of bilateral internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and right park bench position.

Arm/Group Title	R IJV	L IJV
Arm/Group Description	- We studied R IJV flow in the supine and right park bench positions respectively. all measurements were performed on the right eye in a neutral gaze. - We standardised the use of the right side because of ease of access to that side in the laboratory.	- We studied L IJV flow in the supine and right park bench positions respectively. all measurements were performed on the right eye in a neutral gaze. - We standardised the use of the right side because of ease of access to that side in the laboratory.
Measure Participants	27	27
Supine-Cross sectional area (cm2)	1.2 (0.6)	1.0 (0.3)
Right park bench-Cross sectional area	0.9 (0.5)	1.1 (0.5)

3. Primary Outcome

Title	Internal Jugular Venous (IJV) Doppler Velocity
Description	27 volunteers enrolled to measure the Internal Jugular Venous (IJV) in supine and prone positions
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Comparisons of bilateral internal jugular vein (IJV) Doppler velocity between supine and prone position. Data presented as mean (SD) .

Arm/Group Title	R IJV	L IJV
Arm/Group Description	Comparisons of right internal jugular vein (IJV) Doppler velocity between supine and prone position.	Comparisons of left internal jugular vein (IJV) Doppler velocity between supine and prone position.
Measure Participants	27	27
Supine Doppler velocity	19.9 (7)	18.1 (8.4)
Prone Doppler velocity	19.3 (7.9)	13.6 (7.7)

4. Primary Outcome

Title	Bilateral Internal Jugular Vein (IJV) Flow
Description	Comparisons of bilateral internal jugular vein (IJV) flow between supine and prone position. Data presented as mean (SD) .
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Comparisons of bilateral internal jugular vein (IJV) flow between supine and prone position. Data presented as mean (SD) .

Arm/Group Title	R IJV	L IJV
Arm/Group Description	Comparisons of right internal jugular vein (IJV) flow between supine and prone position.	Comparisons of left internal jugular vein (IJV) flow between supine and prone position.
Measure Participants	27	27
Supine Flow	1430.1 (803)	1112.9 (578.1)
Prone Flow	1924.2 (1139.7)	1178.4 (832.1)

5. Primary Outcome

Title	Bilateral Internal Jugular Vein (IJV) Doppler Velocity
Description	Comparisons of bilateral internal jugular vein (IJV) Doppler velocity between supine and right park bench position.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Comparisons of bilateral internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and right park bench position. Data presented as mean (SD).

Arm/Group Title	R IJV	L IJV
Arm/Group Description	Comparisons of right internal jugular vein (IJV) Doppler velocity between supine and right park bench position	Comparisons of left internal jugular vein (IJV) Doppler velocity between supine and right park bench position
Measure Participants	27	27
supine Doppler velocity	19.9 (7)	18.1 (8.4)
right park bench Doppler velocity	28.1 (12)	18.7 (11.6)

6. Primary Outcome

Title	R IJV and L IJV Flow
Description	Bilateral internal jugular vein (IJV) flow between supine and right park bench position.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

Comparisons of bilateral internal jugular vein (IJV) flow between supine and right park bench position. Data presented as mean (SD).

Arm/Group Title	R IJV	L IJV
Arm/Group Description	Comparisons of right internal jugular vein (IJV) Flow between supine and right park bench position	Comparisons of left internal jugular vein (IJV) Flow between supine and right park bench position
Measure Participants	27	27
supine Flow	1430.1 (803)	1112.9 (578.1)
right park bench Flow	1403.1 (1006.1)	1266.9 (959.6)

Adverse Events

Time Frame	1 day
Arm/Group Title	Volunteers in Different Positions
Arm/Group Description	The following will be compared in the same volunteer: Bilateral internal jugular venous flow in supine and prone position Bilateral internal jugular venous flow in supine and park bench position Bilateral internal jugular venous flow in prone and park bench Different positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench
All Cause Mortality
	Volunteers in Different Positions
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Serious Adverse Events
	Volunteers in Different Positions
	Affected / at Risk (%)	# Events
Total	0/27 (0%)
Other (Not Including Serious) Adverse Events
	Volunteers in Different Positions
	Affected / at Risk (%)	# Events
Total	0/27 (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.