NCT02072889

Brief Summary

Measurements will be made between the internal jugular vein and the carotid artery using an ultrasound machine as the subjects is asked to move and position his or her neck in various positions. It is hypothesized that by movements of the neck the investigators can maximize the distance between the internal jugular vein and the carotid artery to decrease inadvertent cannulation of the carotid artery to improve patient safety

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Apr 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

February 10, 2014

Last Update Submit

February 6, 2015

Conditions

Surgery

Keywords

Cardiac SurgeryInternal Jugular CannulationOptimal Neck Angle

Outcome Measures

Primary Outcomes (1)

  • Find Optimal Angle for internal jugular cannulation

    Is there an angle to position ones neck which maximizes distances of carotid artery and internal jugular.

    Approximately 4 years

Secondary Outcomes (1)

  • Find Optimal Neck Angle

    Approx 4 years

Study Arms (1)

Neck Angle Measures

EXPERIMENTAL

Subjects will position his/her neck in order to measure distance between the internal jugular and the carotid artery to determine if there is a maximal distance to target prior to cannulation

Other: Neck Angle

Interventions

Neck AngleOTHER

Ultrasound guided measures of the neck of subjects undergoing cardiac surgery who need internal jugular vein cannulated

Also known as: Position, Measurment, Distance
Neck Angle Measures

Eligibility Criteria

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

You may qualify if:

  • Male and Females 18 years through 98 Scheduled for cardiac surgery Requires internal cannulation for their scheduled operative procedure -

You may not qualify if:

  • Individuals who refuse participation Subjects who already have had the internal jugular cannulated (line already present) History of carotid surgery History of Neck Surgery Individuals under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vincent DeAngelis, MD

    Rutgers Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 27, 2014

Study Start

April 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

US(1)