Ultrasound Guided Vascular Access in Pediatric Intensive Care Patients

NCT00207883 | Completed Results

• 1 other identifier: 04-130
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how fast and accurate two different techniques used by physicians to insert catheters in children are. Catheters are tiny tubes which carry fluids, blood and sometimes liquid food into a person's vein. The technique currently used relies on the physical landmarks and using fingers to feel the anatomy in which to place the catheter in the vein or artery. The investigators are changing to a technique where they will use ultrasound at the patient's bedside to help physicians with placing the catheter into the blood vessel. They are comparing the use of these two methods to determine which is faster and requires fewer needle sticks.

Conditions

Critical Illness

Keywords

Vascular Access; Ultrasound; Pediatric; Pediatric intensive care patient

Outcome Measures

Primary Outcomes (1)

• Central Line Placement Success

  Success was defined as central venous catheter being able to thread into the vessel over the guide wire.

  immediate

Secondary Outcomes (1)

• Time to Successful Central Line Placement

  immediate

Study Arms (2)

Landmark

Procedure/Surgery: Use of landmarks for central line placement

Ultrasound guided

Procedure/Surgery: Use of ultrasound for central line placement

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the Pediatric Intensive care Unit (PICU) at Children's Healthcare of Atlanta at Egleston

You may qualify if:

• All patients admitted to the pediatric intensive care unit (PICU) who require vascular access.

You may not qualify if:

• Age greater than 18 years.
• Any vascular catheter placed outside of the pediatric intensive care unit at Egleston.
• Any vascular catheter placed by a physician other than a member of the pediatric critical care team.

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

Related Publications (23)

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  PMID: 3947185 BACKGROUND

• Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001 Jan;2(1):57-62. doi: 10.1097/00130478-200101000-00012.

  PMID: 12797890 BACKGROUND

• Stenzel JP, Green TP, Fuhrman BP, Carlson PE, Marchessault RP. Percutaneous femoral venous catheterizations: a prospective study of complications. J Pediatr. 1989 Mar;114(3):411-5. doi: 10.1016/s0022-3476(89)80559-1.

  PMID: 2921683 BACKGROUND

• Venkataraman ST, Thompson AE, Orr RA. Femoral vascular catheterization in critically ill infants and children. Clin Pediatr (Phila). 1997 Jun;36(6):311-9. doi: 10.1177/000992289703600601.

  PMID: 9196229 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

• Milling TJ Jr, Rose J, Briggs WM, Birkhahn R, Gaeta TJ, Bove JJ, Melniker LA. Randomized, controlled clinical trial of point-of-care limited ultrasonography assistance of central venous cannulation: the Third Sonography Outcomes Assessment Program (SOAP-3) Trial. Crit Care Med. 2005 Aug;33(8):1764-9. doi: 10.1097/01.ccm.0000171533.92856.e5.

  PMID: 16096454 BACKGROUND

• Leung J, Duffy M, Finckh A. Real-time ultrasonographically-guided internal jugular vein catheterization in the emergency department increases success rates and reduces complications: a randomized, prospective study. Ann Emerg Med. 2006 Nov;48(5):540-7. doi: 10.1016/j.annemergmed.2006.01.011. Epub 2006 Feb 21.

  PMID: 17052555 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

• Keenan SP. Use of ultrasound to place central lines. J Crit Care. 2002 Jun;17(2):126-37. doi: 10.1053/jcrc.2002.34364.

  PMID: 12096376 BACKGROUND

• Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.

  PMID: 12919984 BACKGROUND

• Shojania KG, Duncan BW, McDonald KM, Wachter RM, Markowitz AJ. Making health care safer: a critical analysis of patient safety practices. Evid Rep Technol Assess (Summ). 2001;(43):i-x, 1-668.

  PMID: 11510252 BACKGROUND

• American College of Emergency Physicians.. American College of Emergency Physicians. Use of ultrasound imaging by emergency physicians. Ann Emerg Med. 2001 Oct;38(4):469-70. doi: 10.1067/mem.2001.118487. No abstract available.

  PMID: 11574809 BACKGROUND

• Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Ultrasound-guided internal jugular venous cannulation in infants: a prospective comparison with the traditional palpation method. Anesthesiology. 1999 Jul;91(1):71-7. doi: 10.1097/00000542-199907000-00013.

  PMID: 10422930 BACKGROUND

• Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Comparison of three techniques for internal jugular vein cannulation in infants. Paediatr Anaesth. 2000;10(5):505-11. doi: 10.1046/j.1460-9592.2000.00554.x.

  PMID: 11012954 BACKGROUND

• Leyvi G, Taylor DG, Reith E, Wasnick JD. Utility of ultrasound-guided central venous cannulation in pediatric surgical patients: a clinical series. Paediatr Anaesth. 2005 Nov;15(11):953-8. doi: 10.1111/j.1460-9592.2005.01609.x.

  PMID: 16238556 BACKGROUND

• Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. doi: 10.1093/bja/aeh134. Epub 2004 Apr 30.

  PMID: 15121722 BACKGROUND

• Pirotte T, Veyckemans F. Ultrasound-guided subclavian vein cannulation in infants and children: a novel approach. Br J Anaesth. 2007 Apr;98(4):509-14. doi: 10.1093/bja/aem041. Epub 2007 Mar 1.

  PMID: 17332002 BACKGROUND

• Iwashima S, Ishikawa T, Ohzeki T. Ultrasound-guided versus landmark-guided femoral vein access in pediatric cardiac catheterization. Pediatr Cardiol. 2008 Mar;29(2):339-42. doi: 10.1007/s00246-007-9066-2. Epub 2007 Sep 13.

  PMID: 17851631 BACKGROUND

• Stenzel JP, Green TP, Fuhrman BP, Carlson PE, Marchessault RP. Percutaneous central venous catheterization in a pediatric intensive care unit: a survival analysis of complications. Crit Care Med. 1989 Oct;17(10):984-8. doi: 10.1097/00003246-198910000-00003.

  PMID: 2791583 BACKGROUND

• Diggle PJ, Liang KY, Zeger S: Analysis of Longitudinal Data. New York, NY, Oxford University Press, 1995, pp 162-168, 185- 189

  BACKGROUND

• Johnson EM, Saltzman DA, Suh G, Dahms RA, Leonard AS. Complications and risks of central venous catheter placement in children. Surgery. 1998 Nov;124(5):911-6.

  PMID: 9823406 BACKGROUND

• Mansfield PF, Hohn DC, Fornage BD, Gregurich MA, Ota DM. Complications and failures of subclavian-vein catheterization. N Engl J Med. 1994 Dec 29;331(26):1735-8. doi: 10.1056/NEJM199412293312602.

  PMID: 7984193 BACKGROUND

• Milling T, Holden C, Melniker L, Briggs WM, Birkhahn R, Gaeta T. Randomized controlled trial of single-operator vs. two-operator ultrasound guidance for internal jugular central venous cannulation. Acad Emerg Med. 2006 Mar;13(3):245-7. doi: 10.1197/j.aem.2005.09.004. Epub 2006 Feb 22.

  PMID: 16495416 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size. Personnel were aware they were being timed which can bias study.

Results Point of Contact

• Title: Jana Stockwell, MD
• Organization: Children's Healthcare of Atlanta / Emory University

jana.stockwell@choa.org

404-785-1600

Study Officials

• Jana A Stockwell, MD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

• Curt Froehlich, MD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 18, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)