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

Primary Purpose

Severe Sepsis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound guided radial artery catheterization.
Blind insertion of radial artery catheterization
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound radial artery catheter

Palpation based artery catheterization

Arm Description

Ultrasound guided radial artery catheterization.

Blind insertion of radial artery catheterization

Outcomes

Primary Outcome Measures

First Pass Success When Attempting Arterial Catheterization.
first pass success when attempting arterial catheterization of the artery

Secondary Outcome Measures

Full Information

First Posted
August 8, 2012
Last Updated
August 5, 2015
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01663779
Brief Title
Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters
Official Title
Comparison of Ultrasound-guided Versus Blind Insertion of Radial Artery Catheters.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit further.
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study will be conducted in a prospective randomized design on the patient population of the Surgical Intensive Care Unit (SICU) at Yale New Haven Hospital. All SICU patients 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. Once consent from the patient or his/her surrogate has been obtained, eligible patients will be randomized to either the "Palpation" or the "Ultrasound" group. Sequentially numbered sealed envelopes will be maintained in the SICU. Catheter insertion: The side of insertion (left/right arm) is chosen by the operator. The wrist is positioned by the operator, the skin disinfected and the area draped in a sterile fashion. "Palpation" group": The artery is punctured after location by palpation only. "Ultrasound" group": The artery is punctured under real-time ultrasound only with the probe draped in a sterile sheath. The time from the first skin puncture to confirmed intra-arterial position of the catheter by observing blood return from the catheter is measured with a chronometer by a second person. An arterial pressure waveform must be observed on the monitor to validate intra-arterial catheter placement. Radial artery cannulation will be performed using the "Radial Artery Catheterization Set with Integral Needle Protection" (Ref. RA-04020-SP, Arrows International Inc., Reading PA 19605, USA) containing a 20G catheter on a 22 gauge (22G) puncture needle and a 0.46 mm spring-wire guide. For ultrasound-guided catheter insertion, operators will use the "Site-Rite 6 Ultrasound System" with a linear vascular access probe (5-10 MHz) (Bard Access Systems Inc., 605 North 5600 West, Salt Lake City, UT 84116, USA). Operators: RA catheterization is a typical teaching procedure frequently performed in the ICU. In our unit, arterial lines are placed by either post graduate year 2 (PGY-2) residents (surgery & anesthesia) rotating through the SICU on a monthly basis, or by mid-level providers who are in the unit for indeterminate periods of time. For our study, this will be an important point, as one of our goals will be to demonstrate a learning effect, which is less likely to be observable among the PGY-2 residents who will be present in the unit for a month only. All operators will get instructions (lecture and hands-on training on vascular phantom at the beginning of their SICU rotation) on the use of ultrasound for vascular access and will at all times have the opportunity to exercise their skills on a vessel phantom. Each successful vessel puncture on the vessel phantom must be recorded by the operator, including time and date. For each operator performing the ultrasound-guided insertion on a patient, one of the investigators will be present for supervision and data collection, but not for assistance with insertion, unless required for failure after having used both methods. Cross-over: After three failed attempts at catheterization with the allocated first method, the alternative method must be used; the operator can opt to puncture the RA on the opposite arm. Timing of the first method ends when the operator decides to abandon the third attempt. Timing for the new method starts at the new first skin puncture. Follow up: All catheters will be monitored daily and on days 1 and 3 with clinical and ultrasound examination for the development of complications. The catheter will be followed daily for functional outcomes defined as the quality of the arterial waveform on the monitor and the ability to draw blood from the catheter. The day on which the catheter ceases to function for each of these purposes will be recorded as well as the day of catheter removal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound radial artery catheter
Arm Type
Experimental
Arm Description
Ultrasound guided radial artery catheterization.
Arm Title
Palpation based artery catheterization
Arm Type
Active Comparator
Arm Description
Blind insertion of radial artery catheterization
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided radial artery catheterization.
Intervention Description
Radial artery catheters will be placed with the assistance of bedside ultrasound.
Intervention Type
Procedure
Intervention Name(s)
Blind insertion of radial artery catheterization
Intervention Description
Radial artery catheters will be placed by the palpation technique only.
Primary Outcome Measure Information:
Title
First Pass Success When Attempting Arterial Catheterization.
Description
first pass success when attempting arterial catheterization of the artery
Time Frame
Immediate, upon study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin M Schuster, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34637140
Citation
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.
Results Reference
derived

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

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