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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Tampa General Hospital
Sponsor:
Information provided by (Responsible Party):
Tampa General Hospital
ClinicalTrials.gov Identifier:
NCT00951678
First received: August 3, 2009
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Vascular Anatomy
Other: Observational ultrasonography of venous anatomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of Anatomic Variations of the Internal Jugular and Femoral Veins Using Ultrasound in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Tampa General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Other: Observational ultrasonography of venous anatomy
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951678

Contacts
Contact: Lawrence Land, MD 813.627.5931 lland@health.usf.edu

Locations
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Lawrence Land, MD    813-627-5931    lland@health.usf.edu   
Principal Investigator: Charlotte Derr, MD         
Sponsors and Collaborators
Tampa General Hospital
Investigators
Principal Investigator: Charlotte Derr, MD USF Emergency Medicine Residency Program
  More Information

No publications provided

Responsible Party: Tampa General Hospital
ClinicalTrials.gov Identifier: NCT00951678     History of Changes
Other Study ID Numbers: 106983
Study First Received: August 3, 2009
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tampa General Hospital:
ultrasound
femoral vein
internal jugular vein

ClinicalTrials.gov processed this record on November 20, 2014