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Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters

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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
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:

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
Severe Sepsis Procedure: Ultrasound guided radial artery catheterization. Procedure: Blind insertion of radial artery catheterization

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters.
Study Start Date : August 2012
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. First Pass Success When Attempting Arterial Catheterization. [ Time Frame: Immediate, upon study entry ]
    first pass success when attempting arterial catheterization of the artery



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663779


Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kevin M Schuster, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01663779     History of Changes
Other Study ID Numbers: 1206010421
First Posted: August 13, 2012    Key Record Dates
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes