Ultrasound-Guided Peripheral Venous Access Using AccuCath

NCT02469038 | Completed Results

• 1 other identifier: IRB15-0548
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intravenous Access

Outcome Measures

Primary Outcomes (1)

• First Attempt Success Rate

  Rate of success of first attempt for IV access

  During length of stay in emergency room up to 24 hours

Secondary Outcomes (1)

• IV Procedure Time

  During length of stay in emergency room up to 24 hours

Other Outcomes (5)

• Total Number of Percutaneous Punctures

  During length of stay in emergency room up to 24 hours

• Total Number of IV Catheters

  During length of stay in emergency room up to 24 hours

• Patient Satisfaction Data

  During length of stay in emergency room up to 24 hours

Study Arms (2)

AccuCath catheter

EXPERIMENTAL

We use the AccuCath catheter with ultrasound guidance for IV access for patients in the experimental group.

Device: AccuCath catheter

Control

ACTIVE COMPARATOR

We will use ultrasound-guided conventional IV for patients in the control group.

Device: Control

Interventions

AccuCath catheter DEVICE

Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.

Also known as: Group A

AccuCath catheter

Control DEVICE

Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.

Also known as: Group B, conventional IV catheter

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with IV access need

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead

Related Publications (21)

• Adhikari S, Blaivas M, Morrison D, Lander L. Comparison of infection rates among ultrasound-guided versus traditionally placed peripheral intravenous lines. J Ultrasound Med. 2010 May;29(5):741-7. doi: 10.7863/jum.2010.29.5.741.

  PMID: 20427786 BACKGROUND

• Au AK, Rotte MJ, Grzybowski RJ, Ku BS, Fields JM. Decrease in central venous catheter placement due to use of ultrasound guidance for peripheral intravenous catheters. Am J Emerg Med. 2012 Nov;30(9):1950-4. doi: 10.1016/j.ajem.2012.04.016. Epub 2012 Jul 15.

  PMID: 22795988 BACKGROUND

• Fields JM, Piela NE, Au AK, Ku BS. Risk factors associated with difficult venous access in adult ED patients. Am J Emerg Med. 2014 Oct;32(10):1179-82. doi: 10.1016/j.ajem.2014.07.008. Epub 2014 Jul 30.

  PMID: 25171796 BACKGROUND

• Elia F, Ferrari G, Molino P, Converso M, De Filippi G, Milan A, Apra F. Standard-length catheters vs long catheters in ultrasound-guided peripheral vein cannulation. Am J Emerg Med. 2012 Jun;30(5):712-6. doi: 10.1016/j.ajem.2011.04.019. Epub 2011 Jun 23.

  PMID: 21703801 BACKGROUND

• Lapostolle F, Catineau J, Garrigue B, Monmarteau V, Houssaye T, Vecci I, Treoux V, Hospital B, Crocheton N, Adnet F. Prospective evaluation of peripheral venous access difficulty in emergency care. Intensive Care Med. 2007 Aug;33(8):1452-7. doi: 10.1007/s00134-007-0634-y. Epub 2007 Jun 7.

  PMID: 17554524 BACKGROUND

• Mahler SA, Wang H, Lester C, Skinner J, Arnold TC, Conrad SA. Short- vs long-axis approach to ultrasound-guided peripheral intravenous access: a prospective randomized study. Am J Emerg Med. 2011 Nov;29(9):1194-7. doi: 10.1016/j.ajem.2010.07.015. Epub 2010 Oct 15.

  PMID: 20951527 BACKGROUND

• Dargin JM, Rebholz CM, Lowenstein RA, Mitchell PM, Feldman JA. Ultrasonography-guided peripheral intravenous catheter survival in ED patients with difficult access. Am J Emerg Med. 2010 Jan;28(1):1-7. doi: 10.1016/j.ajem.2008.09.001.

  PMID: 20006193 BACKGROUND

• McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.

  PMID: 12646670 BACKGROUND

• Legler D, Nugent M. Doppler localization of the internal jugular vein facilitates central venous cannulation. Anesthesiology. 1984 May;60(5):481-2. doi: 10.1097/00000542-198405000-00016. No abstract available.

  PMID: 6711857 BACKGROUND

• Yonei A, Nonoue T, Sari A. Real-time ultrasonic guidance for percutaneous puncture of the internal jugular vein. Anesthesiology. 1986 Jun;64(6):830-1. doi: 10.1097/00000542-198606000-00033. No abstract available.

  PMID: 3717653 BACKGROUND

• Miller AH, Roth BA, Mills TJ, Woody JR, Longmoor CE, Foster B. Ultrasound guidance versus the landmark technique for the placement of central venous catheters in the emergency department. Acad Emerg Med. 2002 Aug;9(8):800-5. doi: 10.1111/j.1553-2712.2002.tb02168.x.

  PMID: 12153885 BACKGROUND

• Denys BG, Uretsky BF, Reddy PS. Ultrasound-assisted cannulation of the internal jugular vein. A prospective comparison to the external landmark-guided technique. Circulation. 1993 May;87(5):1557-62. doi: 10.1161/01.cir.87.5.1557.

  PMID: 8491011 BACKGROUND

• Costantino TG, Parikh AK, Satz WA, Fojtik JP. Ultrasonography-guided peripheral intravenous access versus traditional approaches in patients with difficult intravenous access. Ann Emerg Med. 2005 Nov;46(5):456-61. doi: 10.1016/j.annemergmed.2004.12.026.

  PMID: 16271677 BACKGROUND

• Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. doi: 10.1097/00003246-199612000-00020.

  PMID: 8968276 BACKGROUND

• Mallory DL, McGee WT, Shawker TH, Brenner M, Bailey KR, Evans RG, Parker MM, Farmer JC, Parillo JE. Ultrasound guidance improves the success rate of internal jugular vein cannulation. A prospective, randomized trial. Chest. 1990 Jul;98(1):157-60. doi: 10.1378/chest.98.1.157.

  PMID: 2193776 BACKGROUND

• 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.

  BACKGROUND

• Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.

  PMID: 10577399 BACKGROUND

• 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.

  BACKGROUND

• Catney MR, Hillis S, Wakefield B, Simpson L, Domino L, Keller S, Connelly T, White M, Price D, Wagner K. Relationship between peripheral intravenous catheter Dwell time and the development of phlebitis and infiltration. J Infus Nurs. 2001 Sep-Oct;24(5):332-41. doi: 10.1097/00129804-200109000-00008.

  PMID: 11575049 BACKGROUND

• Gregg SC, Murthi SB, Sisley AC, Stein DM, Scalea TM. Ultrasound-guided peripheral intravenous access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. doi: 10.1016/j.jcrc.2009.09.003. Epub 2009 Oct 15.

  PMID: 19836193 BACKGROUND

• 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.

  BACKGROUND

Results Point of Contact

• Title: Melanie Norstrom
• Organization: University of Chicago

mnorstrom@medicine.bsd.uchicago.edu

773-702-1991

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 11, 2015
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 30, 2020
• Results First Posted: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share