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

Sponsor
Tampa General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00951678
Collaborator
(none)
500
1
72
6.9

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Observational ultrasonography of venous anatomy

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
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
Study Start Date :
May 1, 2009
Anticipated Primary Completion Date :
May 1, 2015
Anticipated Study Completion Date :
May 1, 2015

Arms and Interventions

Arm 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.

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

Outcome Measures

Primary Outcome Measures

  1. To determine the variability that exists within the vascular anatomy of the lateral neck and femoral regions [Within the timeframe of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Tampa General Hospital Tampa Florida United States 33606

Sponsors and Collaborators

  • Tampa General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tampa General Hospital
ClinicalTrials.gov Identifier:
NCT00951678
Other Study ID Numbers:
  • 106983
First Posted:
Aug 4, 2009
Last Update Posted:
Apr 30, 2015
Last Verified:
Apr 1, 2015
Keywords provided by Tampa General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 30, 2015