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Ultrasound-Guided Peripheral Venous Access Using AccuCath (AccuCath)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469038
Recruitment Status : Unknown
Verified December 2016 by University of Chicago.
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2015
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

While peripheral venous cannulation is among the most common procedures performed in clinical settings, it is estimated that PIV insertion fails for 6 million patients annually. Failure to establish peripheral venous access in the emergency department is a costly problem, leading to delays in diagnostics and treatment and requiring alternative sites for vascular access. These alternative methods can lead to higher complications rates, decreased patient satisfaction, and increased utilization of nursing and physician time. Complications from PIV failure also pose a significant financial burden to the healthcare system.

Ultrasound guidance has been shown to greatly improve the process of localizing vessels for cannulation. In a healthcare climate that is increasingly focused on outcomes and cost-effectiveness, ultrasound-guided peripheral venous cannulation has become not only a viable but often the preferred method in patients with difficult venous access. Nevertheless, studies to date on ultrasound-guided peripheral venous cannulation have revealed some shortcomings, such as premature failure and low first attempt success rates.

The purpose of our study is to assess whether ultrasound-guided cannulation of a AccuCath catheter, which has a coiled tip guidewire, is superior to ultrasound-guided cannulation of a conventional peripheral IV catheter across clinical outcomes relevant to the emergency department setting.


Condition or disease Intervention/treatment Phase
Intravenous Access Device: AccuCath catheter Device: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Randomized, Controlled Study of Ultrasound-Guided Peripheral Venous Access Using AccuCath Versus Ultrasound-Guided Conventional Intravenous Catheter in the Emergency Department
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: AccuCath catheter
We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group.
Device: AccuCath catheter
Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.
Other Name: Group A

Active Comparator: Control
We will use ultrasound-guided conventional IV for patients in the control group.
Device: Control
Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
Other Names:
  • Group B
  • conventional IV catheter




Primary Outcome Measures :
  1. First attempt success rate [ Time Frame: During intervention period (11 months) ]
    Rate of success of first attempt for IV access


Secondary Outcome Measures :
  1. IV procedure time [ Time Frame: During intervention period (11 months) ]
    Procedure time from the point of first percutaneous puncture to successful cannulation


Other Outcome Measures:
  1. Total number of percutaneous punctures [ Time Frame: During intervention period (11 months) ]
    Total number of percutaneous punctures required for successful cannulation

  2. Total number of IV catheters [ Time Frame: During intervention period (11 months) ]
    Total number of IV catheters required for successful cannulation

  3. Patient satisfaction data [ Time Frame: During intervention period (11 months) ]
    Patient satisfaction data with each catheter system on a 5-point Likert scale

  4. Provider satisfaction data [ Time Frame: During intervention period (11 months) ]
    Provider satisfaction data with each catheter system on a 5-point Likert scale

  5. Clinical and demographic information [ Time Frame: During intervention period (11 months) ]
    Age, sex, ethnicity, medical history



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients with IV access need

Exclusion Criteria:

  • Lack of decisional capacity (e.g., intoxication, dementia, delirium, developmental delay), prior venous grafts or surgery at target IV site, not an acceptable candidate for ultrasound-guided PIV per Mitchell ED protocol (i.e. 3 failed attempts by nurses- 2 by primary nurse, 1 by senior nurse)

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): NCT02469038


Contacts
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Contact: Yong Suh, MD MBA MSc yong.suh@uchospitals.edu
Contact: Gregg Helland, MD hellandg@uchicago.edu

Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Yong Suh, MD MBA MSc University of Chicago
Principal Investigator: Gregg Helland, MD University of Chicago
Principal Investigator: Thomas Spiegel, MD MBA University of Chicago
Publications:
Rothschild JM. Ultrasound guidance of central vein catheterization: making healthcare safer: a critical analysis of patient safety practices. Agency for Healthcare Research and Quality Publication No. 01-E058. http://www.ahrq.gov/clinic/ptsafety.
Thompson DR, Gualtiere E, Deppe S, et al. Greater success in subclavian vein cannulation using ultrasound for inexperienced operators. Crit Care Med. 1994;22:A189.
Idemoto BK, Rowbottom JR, Reynolds JD, Hickman Jr RL. The AccuCath Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters: A Prospective, Randomized, Controlled Comparison. The Journal of the Association for Vascular Access. 2014;19(2):94-102.

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02469038    
Other Study ID Numbers: IRB15-0548
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No