NCT02356887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

July 14, 2020

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

February 2, 2015

Results QC Date

May 15, 2020

Last Update Submit

December 20, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Internal Jugular Venous Flow

    Right Internal Jugular Vein Flow in the sitting position.

    1 day

  • 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

  • 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

  • Right Internal Jugular

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

    one day

Secondary Outcomes (2)

  • Left Internal Jugular Vein Flow in the Sitting Position

    One day

  • Left Internal flow in the Sitting Position

    One day

Study Arms (1)

sitting position

EXPERIMENTAL

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

Interventions

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.

sitting position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult healthy volunteers who are above the age of 18 ASA 1
  • Body mass index (BMI) less than and equal to 35

You may not qualify if:

  • Lack of informed consent
  • Language barrier
  • Medical students and anesthesia residents going through the department as part of their rotation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Results Point of Contact

Title
Emad Al Azazi
Organization
Toronto western Hospital/UHN

Study Officials

  • Lashmi Venkatraghavan, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Department of Anesthesia, Toronto Western Hospital, Toronto, Canada

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 5, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 10, 2023

Results First Posted

July 14, 2020

Record last verified: 2022-12

Locations