Determination of Anatomic Variations of the Internal Jugular and Femoral Veins Using Ultrasound in the Emergency Department

April 29, 2015 updated by: Tampa General Hospital

Central venous catheterization is a common and important procedure done in the emergency department. The internal jugular vein (IJV), subclavian vein (SV) and femoral vein (FV) are commonly used for central venous access. Unfortunately, this procedure has high-risk complications.

Traditionally, physicians have relied on the use of anatomic landmarks and physical manipulation such as moving the head or rotating the leg in order to place central catheters; however, studies have demonstrated that significant anatomic variations exist within large percentages of study populations. In addition, although studies have demonstrated that the use of ultrasonography for placement of femoral catheters leads to lower rates of complications, no previous studies have specifically determined anatomic variations in the femoral triangle. Therefore, this study will examine the anatomic variation of the IJV vs. carotid artery and the femoral vein vs. femoral artery in the emergency room setting. The investigators will study the variation as a function of sex, age, race, body habitus and degree of head rotation (measured using a goniometer) and in doing so, the investigators will demonstrate the utility of using ultrasound to place central lines in order to decrease morbidity.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Contact:
        • Principal Investigator:
          • Charlotte Derr, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Emergency room patients who fit inclusion criteria and consent to participation in the study.

Description

Inclusion Criteria:

  • Patients being cared for in the Tampa General Hospital Emergency Department
  • 18 yrs or older
  • male or female
  • have the anatomy that will be examined (lateral neck and femoral regions)
  • speak either English or Spanish
  • alert and oriented to person, place, time and situation
  • stable vital signs

Exclusion Criteria:

  • under 18 yrs
  • incarcerated individuals
  • those with acute changes in mental status (intoxicated, encephalopathy, psychosis)
  • those from whom consent could not be obtained
  • those requiring intensive care monitoring
  • persons having pathologies that would interfere with the ultrasound investigation
  • persons who do not speak English or Spanish
  • persons with acute or severe mental or cognitive disabilities
  • individuals in a sedated, traumatized or crisis state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ER patients

Subjects must be 18 yrs or older, male or female, and must have the anatomy that we will be examining. Patients will be given the option of enrolling in the study whilst being cared for in Tampa General Hospital Emergency Room.

We anticipate enrolling normal, healthy volunteers, elderly persons (>65) not cognitively impaired, persons with social, economic or educational disadvantages , and persons who do not understand English fluently.

The patient will have ultrasound images obtained of the right and left internal jugular veins as a function of the degree of head rotation and of the right and left femoral veins. Our study is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the variability that exists within the vascular anatomy of the lateral neck and femoral regions
Time Frame: Within the timeframe of the study
Within the timeframe of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charlotte Derr, MD, USF Emergency Medicine Residency Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ANTICIPATED)

May 1, 2015

Study Completion (ANTICIPATED)

May 1, 2015

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (ESTIMATE)

August 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106983

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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