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| Name | Class |
|---|---|
| Lenox Hill Hospital | OTHER |
| Jamaica Hospital Medical Center | OTHER |
| Oklahoma City VA Medical Center | FED |
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Radial artery access for cardiac catheterization can require multiple attempts. Multiple attempts increase the time required, patient discomfort, and the risk of arterial spasm. Ultrasound guidance has been shown in other studies to reduce the number of attempts and complications in central venous and femoral artery access. This study will test if the addition of ultrasound guidance reduces the number of attempts and time required to access the radial artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palpation | Active Comparator | Manual palpation of radial pulse, as sole guide to needle cannulation. |
|
| Ultrasound | Experimental | Real-time ultrasound guidance to facilitate needle cannulation of artery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guidance | Procedure | Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Attempts | Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate. | Immediately during procedure. (up to 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Sheath Insertion (Seconds) | Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded. | Immediately during procedure (within 30 minutes) |
| First-pass Success Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Radial Artery Spasm | Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation | Immediately during procedure (within 30 min) |
| Difficult Access Procedures >= 5 Attempts |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnold H Seto, MD, MPA | University of California, Irvine and Long Beach VA Medical Center | Principal Investigator |
| Zoran Lasic, MD | Lenox Hill Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach VA Medical Center | Long Beach | California | 90822 | United States | ||
| University of California Irvine Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25596790 | Result | Seto AH, Roberts JS, Abu-Fadel MS, Czak SJ, Latif F, Jain SP, Raza JA, Mangla A, Panagopoulos G, Patel PM, Kern MJ, Lasic Z. Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial). JACC Cardiovasc Interv. 2015 Feb;8(2):283-291. doi: 10.1016/j.jcin.2014.05.036. Epub 2015 Jan 14. | |
| 34637140 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Palpation | Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle. |
| FG001 | Ultrasound | Real-time ultrasound guidance to facilitate needle cannulation of artery. Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Palpation | Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle. |
| BG001 | Ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Attempts | Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate. | 473 patients of 698 had number of attempts measured correctly by number of forward passes. This subgroup of the whole population was used for analysis of number of attempts. | Posted | Mean | Standard Deviation | forward attempts | Immediately during procedure. (up to 30 minutes) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Palpation | Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle. |
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Blinding was not possible in this study. We cannot exclude a bias in the performance, measurement, or recording of the procedure or clinical data. Time to prepare the US probe was not included in the time to access.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arnold Seto, MD, MPA | Long Beach VA Medical Center | (562) 826-8000 | 5486 | arnold.seto@va.gov |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Palpation | Procedure | Manual palpation for localizing radial artery for inserting needle. |
|
Proportion of procedures achieving access on the first attempt |
| Immediate |
Difficult procedures were defined as either requiring >= 5 attempts
| Immediately during procedure (within 30 min) |
| Difficult Access >= 5 Minutes | Access that requires >= 5 minutes from first attempt to sheath insertion | Immediate (within 30 minutes) |
| Bleeding Complication | Any hematoma >2 cm or bleeding requiring intervention | After procedure (within 24 hours) |
| Pain Score | Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain. | 2-8 hours after procedure |
| Orange |
| California |
| 92868 |
| United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Jamaica Hospital | Jamaica | New York | 11418 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Oklahoma VA Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2. |
Real-time ultrasound guidance to facilitate needle cannulation of artery.
Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Outpatient | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Obesity, BMI >= 30 | Number | participants |
|
| Hypertension | Number | participants |
|
| Hypercholesterolemia | Number | participants |
|
| Diabetes mellitus | Number | participants |
|
| Tobacco | Number | participants |
|
| Peripheral vascular disease | Number | participants |
|
| Barbeau class B or C | Of those patients receiving Barbeau's test. Barbeau's Class A reflects no reduction of arterial waveform on pulse oximetry after radial artery occlusion, indicating robust collateral flow from the ulnar artery. Barbeau's Class B and C reflect delayed but eventual recovery of arterial waveform on pulse oximetry after radial artery occlusion, indicating the presence of some but limited collaterals from the ulnar artery. Barbeau's Class D patients (no demonstrable collaterals) were excluded from the study. | Number | participants |
|
| Ultrasound |
Real-time ultrasound guidance to facilitate needle cannulation of artery. Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted. |
|
|
|
| Secondary | Time to Sheath Insertion (Seconds) | Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded. | Posted | Mean | Standard Deviation | seconds | Immediately during procedure (within 30 minutes) |
|
|
|
|
| Secondary | First-pass Success Rate | Proportion of procedures achieving access on the first attempt | Subgroup of patients with accurate number of attempts measured | Posted | Number | participants | Immediate |
|
|
|
|
| Other Pre-specified | Radial Artery Spasm | Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation | Posted | Number | participants | Immediately during procedure (within 30 min) |
|
|
|
|
| Other Pre-specified | Difficult Access Procedures >= 5 Attempts | Difficult procedures were defined as either requiring >= 5 attempts | Posted | Number | participants | Immediately during procedure (within 30 min) |
|
|
|
|
| Other Pre-specified | Difficult Access >= 5 Minutes | Access that requires >= 5 minutes from first attempt to sheath insertion | Posted | Number | participants | Immediate (within 30 minutes) |
|
|
|
|
| Other Pre-specified | Bleeding Complication | Any hematoma >2 cm or bleeding requiring intervention | Posted | Number | participants | After procedure (within 24 hours) |
|
|
|
|
| Post-Hoc | Crossover to Ultrasound Rescue Attempts After 5 Minutes | Patients randomized to palpation-guided access could have their procedure changed to ultrasound at operator discretion after 5 minutes of palpation-guided attempts. | Only patients randomized to palpation could potentially cross over to ultrasound technique. | Posted | Number | participants | 5 minutes |
|
|
|
| Post-Hoc | Failure of Radial Sheath Insertion With Original Randomized Technique | Posted | Number | participants | Immediate |
|
|
|
|
| Other Pre-specified | Pain Score | Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain. | Posted | Median | Inter-Quartile Range | units on a scale | 2-8 hours after procedure |
|
|
|
| 0 |
| 351 |
| 0 |
| 351 |
| EG001 | Ultrasound | Real-time ultrasound guidance to facilitate needle cannulation of artery. Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted. | 0 | 347 | 0 | 347 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |