RAUST: Radial Artery Access With Ultrasound Trial

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01605292
• Collaborator: Lenox Hill Hospital (Other), Jamaica Hospital Medical Center (Other), Oklahoma City VA Medical Center (U.S. Fed)
• Enrollment: 698
• Locations: 6
• Arms: 2
• Duration (Months): 15
• Patients Per Site: 116.3
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Procedure: Ultrasound guidance; Procedure: Palpation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 698 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Radial Artery Access With Ultrasound Trial
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Palpation Manual palpation of radial pulse, as sole guide to needle cannulation.	Procedure: Palpation; Manual palpation for localizing radial artery for inserting needle.
Experimental: Ultrasound Real-time ultrasound guidance to facilitate needle cannulation of artery.	Procedure: Ultrasound guidance; Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. First-pass Success Rate [Immediate]

   Proportion of procedures achieving access on the first attempt

Other Outcome Measures

1. 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

2. Difficult Access Procedures >= 5 Attempts [Immediately during procedure (within 30 min)]

   Difficult procedures were defined as either requiring >= 5 attempts

3. Difficult Access >= 5 Minutes [Immediate (within 30 minutes)]

   Access that requires >= 5 minutes from first attempt to sheath insertion

4. Bleeding Complication [After procedure (within 24 hours)]

   Any hematoma >2 cm or bleeding requiring intervention

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach VA Medical Center	Long Beach	California	United States	90822
2	University of California Irvine Medical Center	Orange	California	United States	92868
3	Baptist Hospital of Miami	Miami	Florida	United States	33176
4	Jamaica Hospital	Jamaica	New York	United States	11418
5	Lenox Hill Hospital	New York	New York	United States	10075
6	Oklahoma VA Medical Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of California, Irvine
• Lenox Hill Hospital
• Jamaica Hospital Medical Center
• Oklahoma City VA Medical Center

Investigators

• Principal Investigator: Arnold H Seto, MD, MPA, University of California, Irvine and Long Beach VA Medical Center
• Principal Investigator: Zoran Lasic, MD, Lenox Hill Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arnold Seto, Assistant Clinical Professor, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT01605292
• Other Study ID Numbers: 2011-8432
• First Posted: May 24, 2012
• Last Update Posted: Feb 26, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Arnold Seto, Assistant Clinical Professor, University of California, Irvine: Transradial catheterization; Ultrasound; Radial artery
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Period Title: Overall Study
STARTED	351	347
COMPLETED	351	347
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Palpation	Ultrasound	Total
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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 of all reporting groups
Overall Participants	351	347	698
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (10.6)	61.5 (11.5)	61.9 (11.1)
Sex: Female, Male (Count of Participants)
Female	89 25.4%	93 26.8%	182 26.1%
Male	262 74.6%	254 73.2%	516 73.9%
Outpatient (participants) [Number]
Outpatient	141 40.2%	139 40.1%	280 40.1%
Inpatient or admitted	210 59.8%	208 59.9%	418 59.9%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.2 (7.2)	30.4 (6.9)	30.3 (7.0)
Obesity, BMI >= 30 (participants) [Number]
Obese	153 43.6%	149 42.9%	302 43.3%
Nonobese	198 56.4%	198 57.1%	396 56.7%
Hypertension (participants) [Number]
HTN	305 86.9%	292 84.1%	597 85.5%
Non-HTN	46 13.1%	55 15.9%	101 14.5%
Hypercholesterolemia (participants) [Number]
Hypercholesterolemia	265 75.5%	254 73.2%	519 74.4%
Normal cholesterol	86 24.5%	93 26.8%	179 25.6%
Diabetes mellitus (participants) [Number]
DM	151 43%	149 42.9%	300 43%
No DM	200 57%	198 57.1%	398 57%
Tobacco (participants) [Number]
Tobacco use	107 30.5%	128 36.9%	235 33.7%
No tobacco use	244 69.5%	219 63.1%	463 66.3%
Peripheral vascular disease (participants) [Number]
PVD	16 4.6%	14 4%	30 4.3%
No PVD	335 95.4%	333 96%	668 95.7%
Barbeau class B or C (participants) [Number]
Barbeau's Class A	95 27.1%	93 26.8%	188 26.9%
Barbeau's Class B or C	54 15.4%	56 16.1%	110 15.8%

Outcome Measures

1. Primary Outcome

Title	Number of Attempts
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	237	236
Mean (Standard Deviation) [forward attempts]	3.05 (3.4)	1.65 (1.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Palpation, Ultrasound
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Time to Sheath Insertion (Seconds)
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	351	347
Mean (Standard Deviation) [seconds]	108 (112)	88 (78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Palpation, Ultrasound
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	First-pass Success Rate
Description	Proportion of procedures achieving access on the first attempt
Time Frame	Immediate

Outcome Measure Data

Analysis Population Description

Subgroup of patients with accurate number of attempts measured

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	237	236
Successful first-pass	104 29.6%	153 44.1%
Unsuccessful first-pass	133 37.9%	83 23.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Palpation, Ultrasound
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

4. Other Pre-specified Outcome

Title	Radial Artery Spasm
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	351	347
Number [participants]	12 3.4%	15 4.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Palpation, Ultrasound
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	Fisher Exact
	Comments

5. Other Pre-specified Outcome

Title	Difficult Access Procedures >= 5 Attempts
Description	Difficult procedures were defined as either requiring >= 5 attempts
Time Frame	Immediately during procedure (within 30 min)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	237	236
>=5 attempts	44 12.5%	6 1.7%
<5 attempts	193 55%	230 66.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Palpation, Ultrasound
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

6. Other Pre-specified Outcome

Title	Difficult Access >= 5 Minutes
Description	Access that requires >= 5 minutes from first attempt to sheath insertion
Time Frame	Immediate (within 30 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	351	347
>= 5 minutes	24 6.8%	13 3.7%
< 5 minutes	327 93.2%	334 96.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Palpation, Ultrasound
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Chi-squared
	Comments

7. Other Pre-specified Outcome

Title	Bleeding Complication
Description	Any hematoma >2 cm or bleeding requiring intervention
Time Frame	After procedure (within 24 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	351	347
Number [participants]	4 1.1%	5 1.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Palpation, Ultrasound
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.75
	Comments
	Method	Fisher Exact
	Comments

8. Post-Hoc Outcome

Title	Crossover to Ultrasound Rescue Attempts After 5 Minutes
Description	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

Outcome Measure Data

Analysis Population Description

Only patients randomized to palpation could potentially cross over to ultrasound technique.

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	10	0
Successful rescue with ultrasound	8 2.3%
Unsuccessful rescue with ultrasound	2 0.6%

9. Post-Hoc Outcome

Title	Failure of Radial Sheath Insertion With Original Randomized Technique
Time Frame	Immediate

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	351	347
Number [participants]	15 4.3%	3 0.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Palpation, Ultrasound
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Fisher Exact
	Comments

10. Other Pre-specified Outcome

Title	Pain Score
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Palpation	Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.	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.
Measure Participants	351	347
Median (Inter-Quartile Range) [units on a scale]	0	0

Adverse Events

Arm/Group Title	Palpation		Ultrasound
Arm/Group Description	Manual palpation of radial pulse, as sole guide to needle cannulation. Palpation: Manual palpation for localizing radial artery for inserting needle.		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.
All Cause Mortality
	Palpation		Ultrasound
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Palpation		Ultrasound
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/351 (0%)		0/347 (0%)
Other (Not Including Serious) Adverse Events
	Palpation		Ultrasound
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/351 (0%)		0/347 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.