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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01663779
First received: August 8, 2012
Last updated: June 13, 2014
Last verified: June 2014
  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 (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 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.

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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: 75
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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663779

Contacts
Contact: Kevin M Schuster, MD 203-785-2572 kevin.schuster@yale.edu
Contact: Michael F Ditillo, DO 203-785-2572 michael.ditillo@yale.edu

Locations
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         
Sponsors and Collaborators
Yale University
Investigators
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: June 13, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014