Vascular Access ComplicationsFAUSTNCT00667381
Femoral Arterial Access With Ultrasound Trial
A study testing Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine) in people with Vascular Access Complications and Cardiac Catheterization, run by University of California, Irvine at 4 sites in United States.
Trial summary
This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complications, Cardiac Catheterization, Peripheral Vascular Disease
- What is being tested?
- Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,014 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 and over
- Patients undergoing left heart catheterization or peripheral arterial angiography from the retrograde femoral approach
- Willingness and ability to sign consent form
- Scheduled to have procedure performed by operator trained in the ultrasound technique
Who cannot join
- Access from a site other than the common femoral artery
- Nonpalpable femoral pulses
- Creatinine > 3.0 mg/dl, unless already on dialysis
- Prisoners
- Pregnant women
- Unable or refusal to sign consent form
- Patients undergoing emergent cardiac catheterization for ST segment elevation myocardial infarction or unstable acute coronary syndrome
- Equipment unavailable
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Long Beach Memorial Medical Center
Long Beach, California, 90806
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
University of California, Irvine Medical Center
Orange, California, 92868
About this study
This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.
Read the detailed description
Cardiac catheterization is conventionally performed with femoral arterial access using a combination of arterial pulse palpation, anatomical landmarks, and fluoroscopic landmarks to guide needle insertion. Vascular access complications including hematoma formation, retroperitoneal bleeding, and arterial dissection are the most common types of adverse events associated with cardiac catheterization, and have been associated with insertions above and below the level of the common femoral artery. Real-time ultrasound assistance for central venous catheter placement has been proven in multiple studies to reduce complications, and has been recommended by the Agency for Healthcare Research and Quality as a "Top 11 Highly Proven" patient safety practice. This recommendation has not yet been extended to arterial access, due to a lack of studies to date. However, ultrasound assistance is licensed for and commonly utilized for arterial access, especially in difficult patients.
In a pilot study of 71 procedures performed by the lead researcher, ultrasound guidance was associated with an improved 1st pass success rate (83% vs 47%, p=0.002), reduced risk of accidental venipunctures (0% vs 25%, p=0.002), and greater overall success in common femoral artery cannulation (89% vs 69%, p=0.048) as compared with the fluoroscopic control.
This study is a multicenter prospective randomized trial to generalize the above findings with more patients studied, a larger number of operators, and across several centers. Similar to the previous study, the ultrasound will be used real-time to visualize the femoral vein, femoral artery, and needle tract as the needle is inserted, to guide the needle towards the appropriate location in the artery. The time for insertion, number of passes, complications, and position of the insertion catheter on the femoral angiogram will be analyzed in the setting of patient factors including age, body mass index, and presence of peripheral vascular disease.
- Being tested
- Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)
- Keywords
- Ultrasound guidance, Vascular access, Vascular complications
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)Device
Also called Site-Rite 5 or 6 ultrasound machine.
Real-time ultrasound guidance will be used to aid in femoral artery cannulation. This will occur with a 7 MHz ultrasound probe covered with a sterile cover.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access. |
| Ultrasound | Experimental | Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access. Receives: Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography
Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses.
Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers.
Measured: Immediately, during procedure.
Secondary outcomes (3)
Time to Successful Sheath Insertion.
Time was measured from first fluoroscopy of the femoral head (control group), or first application of the ultrasound probe (ultrasound group), until successful sheath insertion.
Time was not recorded for 1 control patient, and 1 ultrasound patient, these patients were excluded from this analysis but included for other analyses.
Measured: Immediate
Number of Patients With Accidental Femoral Venipunctures.
Number of patients with any femoral venipunctures where an insertion was not intended, i.e. excluding patients with planned right heart catheterization. Multiple accidental venipunctures were not double counted.
Number of attempts and venipunctures were not recorded in 1 control and 1 ultrasound patient, so the denominator is 500 control patients and 502 ultrasound patients.
Measured: Immediate
Number of Participants With Vascular Complications
Vascular complications were defined as vessel thrombosis, dissection, blood transfusion, hematoma > 5cm diameter, unexplained bleeding with a drop in Hgb >4 g/dL, or access site bleeding with drop in Hgb >3 g/dL.
Outcome was assessed by chart review, and clinical or telephone followup at 30 days. Medical records were adjudicated by a blinded independent review committee.
Measured: Immediate and up to 1 month after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationsStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- C. R. Bard, University of Oklahoma, US Department of Veterans Affairs, Long Beach Memorial Medical Center
- Investigators
- Arnold H Seto, MD, MPA, Principal investigator, University of California, IrvineMorton Kern, MD, Principal investigator, University of California, IrvineMazen Abu-Fadel, MD, Principal investigator, Oklahoma Veteran's Administration Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667381
- Sponsor's protocol ID
- HS# 2007-5989
- Acronym
- FAUST
- Status last verified
- Oct 2010
- First submitted
- 24 Apr 2008
- Last updated
- 16 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Seto AH, Abu-Fadel MS, Sparling JM, Zacharias SJ, Daly TS, Harrison AT, Suh WM, Vera JA, Aston CE, Winters RJ, Patel PM, Hennebry TA, Kern MJ. Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: FAUST (Femoral Arterial Access With Ultrasound Trial). JACC Cardiovasc Interv. 2010 Jul;3(7):751-8. doi: 10.1016/j.jcin.2010.04.015.
PubMed 20650437
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Arterial Access With Ultrasound Trial
- ClinicalTrials.gov ID
- NCT00667381
- Acronym / sponsor ID
- FAUST / HS# 2007-5989
- Keywords
- Ultrasound guidance, Vascular access, Vascular complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,014 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- C. R. Bard, University of Oklahoma, US Department of Veterans Affairs, Long Beach Memorial Medical Center
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 16 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.
Detailed description
Cardiac catheterization is conventionally performed with femoral arterial access using a combination of arterial pulse palpation, anatomical landmarks, and fluoroscopic landmarks to guide needle insertion. Vascular access complications including hematoma formation, retroperitoneal bleeding, and arterial dissection are the most common types of adverse events associated with cardiac catheterization, and have been associated with insertions above and below the level of the common femoral artery. Real-time ultrasound assistance for central venous catheter placement has been proven in multiple studies to reduce complications, and has been recommended by the Agency for Healthcare Research and Quality as a "Top 11 Highly Proven" patient safety practice. This recommendation has not yet been extended to arterial access, due to a lack of studies to date. However, ultrasound assistance is licensed for and commonly utilized for arterial access, especially in difficult patients.
In a pilot study of 71 procedures performed by the lead researcher, ultrasound guidance was associated with an improved 1st pass success rate (83% vs 47%, p=0.002), reduced risk of accidental venipunctures (0% vs 25%, p=0.002), and greater overall success in common femoral artery cannulation (89% vs 69%, p=0.048) as compared with the fluoroscopic control.
This study is a multicenter prospective randomized trial to generalize the above findings with more patients studied, a larger number of operators, and across several centers. Similar to the previous study, the ultrasound will be used real-time to visualize the femoral vein, femoral artery, and needle tract as the needle is inserted, to guide the needle towards the appropriate location in the artery. The time for insertion, number of passes, complications, and position of the insertion catheter on the femoral angiogram will be analyzed in the setting of patient factors including age, body mass index, and presence of peripheral vascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access. |
| Ultrasound | Experimental | Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 and over
- Patients undergoing left heart catheterization or peripheral arterial angiography from the retrograde femoral approach
- Willingness and ability to sign consent form
- Scheduled to have procedure performed by operator trained in the ultrasound technique
Key exclusion criteria (8 listed)
- Access from a site other than the common femoral artery
- Nonpalpable femoral pulses
- Creatinine > 3.0 mg/dl, unless already on dialysis
- Prisoners
- Pregnant women
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 |
|---|---|---|
| Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)Also: Site-Rite 5 or 6 ultrasound machine.Real-time ultrasound guidance will be used to aid in femoral artery cannulation. This will occur with a 7 MHz ultrasound probe covered with a sterile cover. | Device | Ultrasound |
Primary outcome
Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography
Time frame: Immediately, during procedure.
Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses. Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers.
3 secondary outcomes
Time to Successful Sheath Insertion.
Time frame: Immediate
Number of Patients With Accidental Femoral Venipunctures.
Time frame: Immediate
Number of Participants With Vascular Complications
Time frame: Immediate and up to 1 month after procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20650437Seto AH, Abu-Fadel MS, Sparling JM, Zacharias SJ, Daly TS, Harrison AT, Suh WM, Vera JA, Aston CE, Winters RJ, Patel PM, Hennebry TA, Kern MJ. Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: FAUST (Femoral Arterial Access With Ultrasound Trial). JACC Cardiovasc Interv. 2010 Jul;3(7):751-8. doi: 10.1016/j.jcin.2010.04.015.
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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.
Arnold H Seto, MD, MPA principal investigator
University of California, Irvine
Morton Kern, MD principal investigator
University of California, Irvine
Mazen Abu-Fadel, MD principal investigator
Oklahoma Veteran's Administration Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine) in people with Vascular Access Complications and Cardiac Catheterization, run by University of California, Irvine at 4 sites 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 16 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography (time frame: Immediately, during procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00667381, which also lists 1 linked publication.
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 16 Nov 2010.