Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters
|ClinicalTrials.gov Identifier: NCT01663779|
Recruitment Status : Terminated (Inability to recruit further.)
First Posted : August 13, 2012
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Arterial catheterization is frequently performed on critically ill patients for invasive blood pressure monitoring and/or frequent blood draws, especially arterial blood gas analysis. The distal part of the radial artery (wrist) is the preferred access site.
The potential complications of the procedure are mostly minor and comprise temporary occlusion of the radial artery (RA), hematoma, local infection or bleeding from the puncture site. Major complications including vessel aneurysm or occlusion with threat to hand viability are rare.
The standard approach to catheterization is "blind" puncture of the RA while locating its pulse by palpation, followed by threading a 20 Gauge (20G) angio-catheter into the vessel. Alternatively ultrasound can be used to locate the vessel and guide needle insertion.
To our knowledge, four prospective randomized trials (PRT)5-8 comparing palpation with ultrasound-guided RA catheterization have been conducted so far and one meta-analysis looked at the pooled data obtained from these. The results showed that ultrasound guidance increased the first-attempt success rate at RA catheterization by 71% compared to palpation. The use of ultrasound also significantly reduced the time to successful catheterization, the number of punctures as well as the amount of catheters required per procedure.
None of the prior randomized trials has been conducted in an ICU setting and in three out of the four studies the arterial lines were placed in patients undergoing elective surgery. The investigators hypothesized that ultrasound could improve first attempt success rate while placing arterial catheters in an ICU setting. Ultrasound may also reduce total time to successful insertion and reduce complications.
The investigators plan to randomize patients to either a palpation technique or ultrasound guided catheter insertion and record the above outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis||Procedure: Ultrasound guided radial artery catheterization. Procedure: Blind insertion of radial artery catheterization||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Ultrasound radial artery catheter
Ultrasound guided radial artery catheterization.
Procedure: Ultrasound guided radial artery catheterization.
Radial artery catheters will be placed with the assistance of bedside ultrasound.
Active Comparator: Palpation based artery catheterization
Blind insertion of radial artery catheterization
Procedure: Blind insertion of radial artery catheterization
Radial artery catheters will be placed by the palpation technique only.
- First Pass Success When Attempting Arterial Catheterization. [ Time Frame: Immediate, upon study entry ]first pass success when attempting arterial catheterization of the artery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663779
|United States, Connecticut|
|Yale New Haven Hospital|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Kevin M Schuster, MD||Yale University|