Cardiac Catheterization, Peripheral Vascular Disease, Vascular Access Complications
Conditions
Keywords
Ultrasound guidance, Vascular access, Vascular complications
Brief 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.
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.
Interventions
DEVICEReal-time Ultrasound Guidance (Site-Rite 5 or 6 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.
Sponsors
C. R. Bard
University of Oklahoma
US Department of Veterans Affairs
Long Beach Memorial Medical Center
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful Sheath Insertion. | Immediate | 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. |
| Number of Patients With Accidental Femoral Venipunctures. | Immediate | 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. |
| Number of Participants With Vascular Complications | Immediate and up to 1 month after procedure. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations | At angiogram analysis | Patients found to have femoral artery bifurcations occurring over the femoral head were prospectively defined as having a high femoral bifurcation. This subgroup was prespecified for analysis during the trial designed, as it was suspected that operators would have particular difficulty inserting the sheath accurately in this population. |
Countries
United States
Participant flow
Recruitment details
Between April 2008 and February 2009, 1014 patients presenting for elective or urgent (but not emergent) cardiac or peripheral catheterization were enrolled.
Pre-assignment details
10 patients (6 control, 4 US) were excluded after randomization but before procedure for no longer meeting the inclusion criteria, including cancellation of the procedure, lack of a dual-trained operator, or change in access site. Baseline and procedural data were not recorded in this group, and these were not included in any analysis.
Participants by arm
| Arm | Count |
|---|---|
| Control The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access. | 501 |
| Ultrasound Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access. | 503 |
| Total | 1,004 |
Baseline characteristics
| Characteristic | Ultrasound | Total | Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 230 Participants | 476 Participants | 246 Participants |
| Age, Categorical Between 18 and 65 years | 273 Participants | 528 Participants | 255 Participants |
| Age Continuous | 63.5 years STANDARD_DEVIATION 12.4 | 63.8 years STANDARD_DEVIATION 11.9 | 64.2 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 503 participants | 1004 participants | 501 participants |
| Sex: Female, Male Female | 132 Participants | 267 Participants | 135 Participants |
| Sex: Female, Male Male | 371 Participants | 737 Participants | 366 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 501 | 7 / 503 |
| serious Total, serious adverse events | 0 / 501 | 0 / 503 |
Outcome results
Primary
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.
Time frame: Immediately, during procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography | 408 participants |
| Ultrasound | Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography | 431 participants |
Secondary
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.
Time frame: Immediate and up to 1 month after procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Participants With Vascular Complications | 17 participants |
| Ultrasound | Number of Participants With Vascular Complications | 7 participants |
Secondary
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.
Time frame: Immediate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Patients With Accidental Femoral Venipunctures. | 79 participants |
| Ultrasound | Number of Patients With Accidental Femoral Venipunctures. | 12 participants |
Secondary
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.
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Time to Successful Sheath Insertion. | 213 seconds | Standard Deviation 194 |
| Ultrasound | Time to Successful Sheath Insertion. | 185 seconds | Standard Deviation 175 |
Other Pre-specified
Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations
Patients found to have femoral artery bifurcations occurring over the femoral head were prospectively defined as having a high femoral bifurcation. This subgroup was prespecified for analysis during the trial designed, as it was suspected that operators would have particular difficulty inserting the sheath accurately in this population.
Time frame: At angiogram analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations | 111 participants |
| Ultrasound | Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations | 123 participants |