Coronary Artery Disease
Conditions
Keywords
Transradial catheterization, Ultrasound, Radial artery
Brief summary
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.
Interventions
PROCEDUREUltrasound guidance
Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.
PROCEDUREPalpation
Manual palpation for localizing radial artery for inserting needle.
Sponsors
Lenox Hill Hospital
Jamaica Hospital Medical Center
Oklahoma City VA Medical Center
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients presenting for cardiac or peripheral catheterization with planned radial approach. * Barbeau's or Allen's test indicating at least some degree of collateral circulation in palmar vessels * Functional ultrasound equipment with ultrasound trained attending operator
Exclusion criteria
* Inability to provide informed consent * Femoral access * Emergency procedure (Shock, STEMI) * End-stage renal disease on hemodialysis * Previous ipsilateral puncture within 1 week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts | Immediately during procedure. (up to 30 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Sheath Insertion (Seconds) | Immediately during procedure (within 30 minutes) | 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. |
| First-pass Success Rate | Immediate | Proportion of procedures achieving access on the first attempt |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Complication | After procedure (within 24 hours) | Any hematoma \>2 cm or bleeding requiring intervention |
| Radial Artery Spasm | Immediately during procedure (within 30 min) | Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation |
| Pain Score | 2-8 hours after procedure | 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. |
| Difficult Access Procedures >= 5 Attempts | Immediately during procedure (within 30 min) | Difficult procedures were defined as either requiring \>= 5 attempts |
| Difficult Access >= 5 Minutes | Immediate (within 30 minutes) | Access that requires \>= 5 minutes from first attempt to sheath insertion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Palpation Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle. | 351 |
| 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. | 347 |
| Total | 698 |
Baseline characteristics
| Characteristic | Ultrasound | Total | Palpation |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 11.5 | 61.9 years STANDARD_DEVIATION 11.1 | 62.3 years STANDARD_DEVIATION 10.6 |
| Barbeau class B or C Barbeau's Class A | 93 participants | 188 participants | 95 participants |
| Barbeau class B or C Barbeau's Class B or C | 56 participants | 110 participants | 54 participants |
| BMI | 30.4 kg/m^2 STANDARD_DEVIATION 6.9 | 30.3 kg/m^2 STANDARD_DEVIATION 7 | 30.2 kg/m^2 STANDARD_DEVIATION 7.2 |
| Diabetes mellitus DM | 149 participants | 300 participants | 151 participants |
| Diabetes mellitus No DM | 198 participants | 398 participants | 200 participants |
| Hypercholesterolemia Hypercholesterolemia | 254 participants | 519 participants | 265 participants |
| Hypercholesterolemia Normal cholesterol | 93 participants | 179 participants | 86 participants |
| Hypertension HTN | 292 participants | 597 participants | 305 participants |
| Hypertension Non-HTN | 55 participants | 101 participants | 46 participants |
| Obesity, BMI >= 30 Nonobese | 198 participants | 396 participants | 198 participants |
| Obesity, BMI >= 30 Obese | 149 participants | 302 participants | 153 participants |
| Outpatient Inpatient or admitted | 208 participants | 418 participants | 210 participants |
| Outpatient Outpatient | 139 participants | 280 participants | 141 participants |
| Peripheral vascular disease No PVD | 333 participants | 668 participants | 335 participants |
| Peripheral vascular disease PVD | 14 participants | 30 participants | 16 participants |
| Sex: Female, Male Female | 93 Participants | 182 Participants | 89 Participants |
| Sex: Female, Male Male | 254 Participants | 516 Participants | 262 Participants |
| Tobacco No tobacco use | 219 participants | 463 participants | 244 participants |
| Tobacco Tobacco use | 128 participants | 235 participants | 107 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 351 | 0 / 347 |
| serious Total, serious adverse events | 0 / 351 | 0 / 347 |
Outcome results
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.
Time frame: Immediately during procedure. (up to 30 minutes)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palpation | Number of Attempts | 3.05 forward attempts | Standard Deviation 3.4 |
| Ultrasound | Number of Attempts | 1.65 forward attempts | Standard Deviation 1.2 |
p-value: <0.0001t-test, 2 sided
Secondary
First-pass Success Rate
Proportion of procedures achieving access on the first attempt
Time frame: Immediate
Population: Subgroup of patients with accurate number of attempts measured
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palpation | First-pass Success Rate | Successful first-pass | 104 participants |
| Palpation | First-pass Success Rate | Unsuccessful first-pass | 133 participants |
| Ultrasound | First-pass Success Rate | Successful first-pass | 153 participants |
| Ultrasound | First-pass Success Rate | Unsuccessful first-pass | 83 participants |
p-value: <0.0001Fisher Exact
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.
Time frame: Immediately during procedure (within 30 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Palpation | Time to Sheath Insertion (Seconds) | 108 seconds | Standard Deviation 112 |
| Ultrasound | Time to Sheath Insertion (Seconds) | 88 seconds | Standard Deviation 78 |
p-value: 0.006t-test, 2 sided
Other Pre-specified
Bleeding Complication
Any hematoma \>2 cm or bleeding requiring intervention
Time frame: After procedure (within 24 hours)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palpation | Bleeding Complication | 4 participants |
| Ultrasound | Bleeding Complication | 5 participants |
p-value: 0.75Fisher Exact
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.
Time frame: 5 minutes
Population: Only patients randomized to palpation could potentially cross over to ultrasound technique.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palpation | Crossover to Ultrasound Rescue Attempts After 5 Minutes | Successful rescue with ultrasound | 8 participants |
| Palpation | Crossover to Ultrasound Rescue Attempts After 5 Minutes | Unsuccessful rescue with ultrasound | 2 participants |
Other Pre-specified
Difficult Access >= 5 Minutes
Access that requires \>= 5 minutes from first attempt to sheath insertion
Time frame: Immediate (within 30 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palpation | Difficult Access >= 5 Minutes | < 5 minutes | 327 participants |
| Palpation | Difficult Access >= 5 Minutes | >= 5 minutes | 24 participants |
| Ultrasound | Difficult Access >= 5 Minutes | >= 5 minutes | 13 participants |
| Ultrasound | Difficult Access >= 5 Minutes | < 5 minutes | 334 participants |
p-value: 0.07Chi-squared
Other Pre-specified
Difficult Access Procedures >= 5 Attempts
Difficult procedures were defined as either requiring \>= 5 attempts
Time frame: Immediately during procedure (within 30 min)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palpation | Difficult Access Procedures >= 5 Attempts | >=5 attempts | 44 participants |
| Palpation | Difficult Access Procedures >= 5 Attempts | <5 attempts | 193 participants |
| Ultrasound | Difficult Access Procedures >= 5 Attempts | >=5 attempts | 6 participants |
| Ultrasound | Difficult Access Procedures >= 5 Attempts | <5 attempts | 230 participants |
p-value: <0.0001Fisher Exact
Post Hoc
Failure of Radial Sheath Insertion With Original Randomized Technique
Time frame: Immediate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palpation | Failure of Radial Sheath Insertion With Original Randomized Technique | 15 participants |
| Ultrasound | Failure of Radial Sheath Insertion With Original Randomized Technique | 3 participants |
p-value: 0.007Fisher Exact
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.
Time frame: 2-8 hours after procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palpation | Pain Score | 0 units on a scale |
| Ultrasound | Pain Score | 0 units on a scale |
Other Pre-specified
Radial Artery Spasm
Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation
Time frame: Immediately during procedure (within 30 min)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palpation | Radial Artery Spasm | 12 participants |
| Ultrasound | Radial Artery Spasm | 15 participants |
p-value: 0.56Fisher Exact