- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951678
Determination of Anatomic Variations of the Internal Jugular and Femoral Veins Using Ultrasound in the Emergency Department
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33606
- Recruiting
- Tampa General Hospital
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Contact:
- Lawrence Land, MD
- Phone Number: 813-627-5931
- Email: lland@health.usf.edu
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Principal Investigator:
- Charlotte Derr, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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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
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Within the timeframe of the study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charlotte Derr, MD, USF Emergency Medicine Residency Program
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106983
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