Vascular AnatomyNCT00951678
Determination of Anatomic Variations of the Internal Jugular and Femoral Veins Using Ultrasound in the Emergency Department
An observational study of Vascular Anatomy, run by Tampa General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Anatomy
- What is being tested?
- Observational ultrasonography of venous anatomy
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emergency room patients who fit inclusion criteria and consent to participation in the study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Lawrence Land, MD, 813-627-5931, lland@health.usf.edu
Charlotte Derr, MD
About this study
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.
- Conditions
- Vascular Anatomy
- Being tested
- Observational ultrasonography of venous anatomy
- Keywords
- ultrasound, femoral vein, internal jugular vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational ultrasonography of venous anatomyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational ultrasonography of venous anatomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the variability that exists within the vascular anatomy of the lateral neck and femoral regions
Measured: Within the timeframe of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AnatomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampa General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Derr, MD, Principal investigator, USF Emergency Medicine Residency Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951678
- Sponsor's protocol ID
- 106983
- Status last verified
- Apr 2015
- First submitted
- 3 Aug 2009
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Anatomic Variations of the Internal Jugular and Femoral Veins Using Ultrasound in the Emergency Department
- ClinicalTrials.gov ID
- NCT00951678
- Acronym / sponsor ID
- 106983
- Conditions
- Vascular Anatomy
- Keywords
- ultrasound, femoral vein, internal jugular vein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tampa General HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ER patients | – | Other: Observational ultrasonography of venous anatomySubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency room patients who fit inclusion criteria and consent to participation in the study.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational ultrasonography of venous anatomyThe 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 | Other | ER patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Derr, MD principal investigator
USF Emergency Medicine Residency Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Anatomy, run by Tampa General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lawrence Land, MD (813.627.5931, lland@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.