Trial Outcomes & Findings for Radial Artery Access With Ultrasound Trial (NCT NCT01605292)
NCT ID: NCT01605292
Last Updated: 2015-02-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
698 participants
Primary outcome timeframe
Immediately during procedure. (up to 30 minutes)
Results posted on
2015-02-26
Participant Flow
Participant milestones
| Measure |
Palpation
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
351
|
347
|
|
Overall Study
COMPLETED
|
351
|
347
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radial Artery Access With Ultrasound Trial
Baseline characteristics by cohort
| Measure |
Palpation
n=351 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=347 Participants
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.
|
Total
n=698 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
61.5 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
61.9 years
STANDARD_DEVIATION 11.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
182 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
262 Participants
n=93 Participants
|
254 Participants
n=4 Participants
|
516 Participants
n=27 Participants
|
|
Outpatient
Outpatient
|
141 participants
n=93 Participants
|
139 participants
n=4 Participants
|
280 participants
n=27 Participants
|
|
Outpatient
Inpatient or admitted
|
210 participants
n=93 Participants
|
208 participants
n=4 Participants
|
418 participants
n=27 Participants
|
|
BMI
|
30.2 kg/m^2
STANDARD_DEVIATION 7.2 • n=93 Participants
|
30.4 kg/m^2
STANDARD_DEVIATION 6.9 • n=4 Participants
|
30.3 kg/m^2
STANDARD_DEVIATION 7.0 • n=27 Participants
|
|
Obesity, BMI >= 30
Obese
|
153 participants
n=93 Participants
|
149 participants
n=4 Participants
|
302 participants
n=27 Participants
|
|
Obesity, BMI >= 30
Nonobese
|
198 participants
n=93 Participants
|
198 participants
n=4 Participants
|
396 participants
n=27 Participants
|
|
Hypertension
HTN
|
305 participants
n=93 Participants
|
292 participants
n=4 Participants
|
597 participants
n=27 Participants
|
|
Hypertension
Non-HTN
|
46 participants
n=93 Participants
|
55 participants
n=4 Participants
|
101 participants
n=27 Participants
|
|
Hypercholesterolemia
Hypercholesterolemia
|
265 participants
n=93 Participants
|
254 participants
n=4 Participants
|
519 participants
n=27 Participants
|
|
Hypercholesterolemia
Normal cholesterol
|
86 participants
n=93 Participants
|
93 participants
n=4 Participants
|
179 participants
n=27 Participants
|
|
Diabetes mellitus
DM
|
151 participants
n=93 Participants
|
149 participants
n=4 Participants
|
300 participants
n=27 Participants
|
|
Diabetes mellitus
No DM
|
200 participants
n=93 Participants
|
198 participants
n=4 Participants
|
398 participants
n=27 Participants
|
|
Tobacco
Tobacco use
|
107 participants
n=93 Participants
|
128 participants
n=4 Participants
|
235 participants
n=27 Participants
|
|
Tobacco
No tobacco use
|
244 participants
n=93 Participants
|
219 participants
n=4 Participants
|
463 participants
n=27 Participants
|
|
Peripheral vascular disease
PVD
|
16 participants
n=93 Participants
|
14 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
Peripheral vascular disease
No PVD
|
335 participants
n=93 Participants
|
333 participants
n=4 Participants
|
668 participants
n=27 Participants
|
|
Barbeau class B or C
Barbeau's Class A
|
95 participants
n=93 Participants
|
93 participants
n=4 Participants
|
188 participants
n=27 Participants
|
|
Barbeau class B or C
Barbeau's Class B or C
|
54 participants
n=93 Participants
|
56 participants
n=4 Participants
|
110 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Palpation
n=237 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=236 Participants
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.
|
|---|---|---|
|
Number of Attempts
|
3.05 forward attempts
Standard Deviation 3.4
|
1.65 forward attempts
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Palpation
n=351 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=347 Participants
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.
|
|---|---|---|
|
Time to Sheath Insertion (Seconds)
|
108 seconds
Standard Deviation 112
|
88 seconds
Standard Deviation 78
|
SECONDARY outcome
Timeframe: ImmediatePopulation: Subgroup of patients with accurate number of attempts measured
Proportion of procedures achieving access on the first attempt
Outcome measures
| Measure |
Palpation
n=237 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=236 Participants
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.
|
|---|---|---|
|
First-pass Success Rate
Successful first-pass
|
104 participants
|
153 participants
|
|
First-pass Success Rate
Unsuccessful first-pass
|
133 participants
|
83 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately during procedure (within 30 min)Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation
Outcome measures
| Measure |
Palpation
n=351 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=347 Participants
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.
|
|---|---|---|
|
Radial Artery Spasm
|
12 participants
|
15 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately during procedure (within 30 min)Difficult procedures were defined as either requiring \>= 5 attempts
Outcome measures
| Measure |
Palpation
n=237 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=236 Participants
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.
|
|---|---|---|
|
Difficult Access Procedures >= 5 Attempts
>=5 attempts
|
44 participants
|
6 participants
|
|
Difficult Access Procedures >= 5 Attempts
<5 attempts
|
193 participants
|
230 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediate (within 30 minutes)Access that requires \>= 5 minutes from first attempt to sheath insertion
Outcome measures
| Measure |
Palpation
n=351 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=347 Participants
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.
|
|---|---|---|
|
Difficult Access >= 5 Minutes
>= 5 minutes
|
24 participants
|
13 participants
|
|
Difficult Access >= 5 Minutes
< 5 minutes
|
327 participants
|
334 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After procedure (within 24 hours)Any hematoma \>2 cm or bleeding requiring intervention
Outcome measures
| Measure |
Palpation
n=351 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=347 Participants
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.
|
|---|---|---|
|
Bleeding Complication
|
4 participants
|
5 participants
|
POST_HOC outcome
Timeframe: 5 minutesPopulation: Only patients randomized to palpation could potentially cross over to ultrasound technique.
Patients randomized to palpation-guided access could have their procedure changed to ultrasound at operator discretion after 5 minutes of palpation-guided attempts.
Outcome measures
| Measure |
Palpation
n=10 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
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.
|
|---|---|---|
|
Crossover to Ultrasound Rescue Attempts After 5 Minutes
Successful rescue with ultrasound
|
8 participants
|
—
|
|
Crossover to Ultrasound Rescue Attempts After 5 Minutes
Unsuccessful rescue with ultrasound
|
2 participants
|
—
|
POST_HOC outcome
Timeframe: ImmediateOutcome measures
| Measure |
Palpation
n=351 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=347 Participants
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.
|
|---|---|---|
|
Failure of Radial Sheath Insertion With Original Randomized Technique
|
15 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-8 hours after procedurePatient-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.
Outcome measures
| Measure |
Palpation
n=351 Participants
Manual palpation of radial pulse, as sole guide to needle cannulation.
Palpation: Manual palpation for localizing radial artery for inserting needle.
|
Ultrasound
n=347 Participants
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.
|
|---|---|---|
|
Pain Score
|
0 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 1.0
|
Adverse Events
Palpation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place