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

NCT01663779 | Terminated Results

• 1 other identifier: 1206010421
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• First Pass Success When Attempting Arterial Catheterization.

  first pass success when attempting arterial catheterization of the artery

  Immediate, upon study entry

Study Arms (2)

Ultrasound radial artery catheter

EXPERIMENTAL

Ultrasound guided radial artery catheterization.

Procedure: Ultrasound guided radial artery catheterization.

Palpation based artery catheterization

ACTIVE COMPARATOR

Blind insertion of radial artery catheterization

Procedure: Blind insertion of radial artery catheterization

Interventions

Ultrasound guided radial artery catheterization. PROCEDURE

Radial artery catheters will be placed with the assistance of bedside ultrasound.

Ultrasound radial artery catheter

Blind insertion of radial artery catheterization PROCEDURE

Radial artery catheters will be placed by the palpation technique only.

Palpation based artery catheterization

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient or his/her surrogate declines to participate or the patient lacks a radial artery into which a catheter can be place.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

  PMID: 34637140 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Kevin M. Schuster
• Organization: Yale School of Medicine

kevin.schuster@yale.edu

203-785-2572

Study Officials

• Kevin M Schuster, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 13, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 31, 2015
• Results First Posted: August 31, 2015

Record last verified: 2015-08

Locations

US (1)