Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters
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Purpose
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 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 | Intervention |
|---|---|
|
Severe Sepsis |
Procedure: Ultrasound guided radial artery catheterization. Procedure: Blind insertion of radial artery catheterization |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters. |
- First pass attempt arterial catheterization success rate [ Time Frame: immediately (approximately 1 minute) ] [ Designated as safety issue: No ]Compare first pass attempt success rate for radial artery catheterization with and without the use of ultrasound localization in an ICU setting.
| Estimated Enrollment: | 214 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All surgical intensive care unit patients at Yale New Haven Hospital in whom the indication for arterial catheterization has been established by the attending physician will be eligible for consented randomization to either the "Palpation" or the "Ultrasound" group.
Exclusion Criteria:
- The patient or his/her surrogate declines to participate or the patient lacks a radial artery into which a catheter can be place.
Contacts and Locations| Contact: Kevin M Schuster, MD | 203-785-2572 | kevin.schuster@yale.edu |
| Contact: Michael F Ditillo, DO | 203-785-2572 | michael.ditillo@yale.edu |
| United States, Connecticut | |
| Yale New Haven Hospital | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Kevin M Schuster, MD 203-785-2572 kevin.schuster@yale.edu | |
| Principal Investigator: Kevin M Schuster, MD | |
| Sub-Investigator: Tobias Zingg, MD | |
| Sub-Investigator: Michael F Ditillo, DO | |
| Sub-Investigator: Linda L Maerz, MD | |
| Sub-Investigator: Matthew Band, PA | |
| Principal Investigator: | Kevin M Schuster, MD | Yale University |
More Information
No publications provided
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01663779 History of Changes |
| Other Study ID Numbers: | 1206010421 |
| Study First Received: | August 8, 2012 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013