NCT02002507

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 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

4.9 years

First QC Date

November 29, 2013

Last Update Submit

December 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Jugular venous flow

    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 Outcomes (2)

  • cross- sectional area of internal jugular vein

    1 day

  • doppler velocity of jugular venous flow

    1 day

Study Arms (2)

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

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

Interventions

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)

park bench positionprone position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neurosurgical patients in either park bench or prone position for their surgery

You may qualify if:

  • 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

You may not qualify if:

  • Lack of informed consent
  • Patients undergoing surgical procedures only in the supine position
  • Patients needing a central venous catheter in the neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 29, 2013

First Posted

December 5, 2013

Study Start

January 1, 2015

Primary Completion

November 21, 2019

Study Completion

December 31, 2019

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations