Ultrasound Guided IV Access in a Pediatric Emergency Department

NCT02125552 | Completed

• 1 other identifier: 13-010758
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. Secondary objectives include determining whether ultrasound-guided IV access lowers the overall number of IV attempts and/or reduces time to IV access. The investigators will also examine the duration of IV access and any complications related to IV access in both the traditional and ultrasound guided IV access group.

Conditions

Difficult Intravenous Access in Pediatrics

Keywords

vascular access device; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Success of Initial IV Placement Attempt

  Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment. The IV will be placed directly following enrollment.

  Participants will be followed through the duration of emergency department stay, an expected average of 4 hours

Secondary Outcomes (4)

• Measure the overall number of IV attempts..

  Participants will be followed through the duration of emergency department stay, an expected average of 4 hours

• Time to IV access.

  Participants will be followed through the duration of emergency department stay, an expected average of 4 hours

• Patient & family satisfaction with IV placement method.

  Participants will be followed through the duration of emergency department stay, an expected average of 4 hours

• Compare the survival (in length of time) of IV access

  Participants will be followed through the duration of hospital stay, expected average of 5 days

Study Arms (2)

Ultrasound guided intravenous access

EXPERIMENTAL

This group will have their IV placed by ultrasound guidance.

Procedure: Ultrasound guidance

Traditional intravenous access

PLACEBO COMPARATOR

The patients randomized to traditional IV access will have their IVs placed by standard technique.

Procedure: Traditional intravenous access

Interventions

Ultrasound guidance PROCEDURE

The ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group

Ultrasound guided intravenous access

Traditional intravenous access PROCEDURE

Placement by experienced nurse using standard IV techniques

Also known as: Standard of Care arm

Traditional intravenous access

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Emergency department patients ages 0-18 years
• Requiring IV access as determined by emergency department attending physician
• Predicted difficult IV access as defined by a revised DIVA score \>3

You may not qualify if:

• Unstable patients triaged as a Level 1 triage acuity
• Patients who refuse IV access
• Non-English speaking parent/guardian
• No study team member available to enroll patient
• Parent/guardian does not consent
• Allergy to ultrasound gel

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (19)

• Fein JA, Callahan JM, Boardman CR, Gorelick MH. Predicting the need for topical anesthetic in the pediatric emergency department. Pediatrics. 1999 Aug;104(2):e19. doi: 10.1542/peds.104.2.e19.

  PMID: 10429137 BACKGROUND

• Frey AM. Success rates for peripheral i.v. insertion in a children's hospital. Financial implications. J Intraven Nurs. 1998 May-Jun;21(3):160-5.

  PMID: 9652275 BACKGROUND

• Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.

  PMID: 18347490 BACKGROUND

• Riker MW, Kennedy C, Winfrey BS, Yen K, Dowd MD. Validation and refinement of the difficult intravenous access score: a clinical prediction rule for identifying children with difficult intravenous access. Acad Emerg Med. 2011 Nov;18(11):1129-34. doi: 10.1111/j.1553-2712.2011.01205.x.

  PMID: 22092893 BACKGROUND

• Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.

  PMID: 19262420 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

• 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

• 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

• 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

• Benkhadra M, Collignon M, Fournel I, Oeuvrard C, Rollin P, Perrin M, Volot F, Girard C. Ultrasound guidance allows faster peripheral IV cannulation in children under 3 years of age with difficult venous access: a prospective randomized study. Paediatr Anaesth. 2012 May;22(5):449-54. doi: 10.1111/j.1460-9592.2012.03830.x. Epub 2012 Mar 12.

  PMID: 22409596 BACKGROUND

• Heinrichs J, Fritze Z, Vandermeer B, Klassen T, Curtis S. Ultrasonographically guided peripheral intravenous cannulation of children and adults: a systematic review and meta-analysis. Ann Emerg Med. 2013 Apr;61(4):444-454.e1. doi: 10.1016/j.annemergmed.2012.11.014. Epub 2013 Feb 15.

  PMID: 23415740 BACKGROUND

• Bair AE, Rose JS, Vance CW, Andrada-Brown E, Kuppermann N. Ultrasound-assisted peripheral venous access in young children: a randomized controlled trial and pilot feasibility study. West J Emerg Med. 2008 Nov;9(4):219-24.

  PMID: 19561750 BACKGROUND

• Aponte H, Acosta S, Rigamonti D, Sylvia B, Austin P, Samolitis T. The use of ultrasound for placement of intravenous catheters. AANA J. 2007 Jun;75(3):212-6.

  PMID: 17591303 BACKGROUND

• Bauman M, Braude D, Crandall C. Ultrasound-guidance vs. standard technique in difficult vascular access patients by ED technicians. Am J Emerg Med. 2009 Feb;27(2):135-40. doi: 10.1016/j.ajem.2008.02.005.

  PMID: 19371518 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

• Lininger RA. Pediatric peripheral i.v. insertion success rates. Pediatr Nurs. 2003 Sep-Oct;29(5):351-4.

  PMID: 14651305 BACKGROUND

• Panebianco NL, Fredette JM, Szyld D, Sagalyn EB, Pines JM, Dean AJ. What you see (sonographically) is what you get: vein and patient characteristics associated with successful ultrasound-guided peripheral intravenous placement in patients with difficult access. Acad Emerg Med. 2009 Dec;16(12):1298-1303. doi: 10.1111/j.1553-2712.2009.00520.x. Epub 2009 Nov 12.

  PMID: 19912132 BACKGROUND

• Schnadower D, Lin S, Perera P, Smerling A, Dayan P. A pilot study of ultrasound analysis before pediatric peripheral vein cannulation attempt. Acad Emerg Med. 2007 May;14(5):483-5. doi: 10.1197/j.aem.2006.12.016.

  PMID: 17392522 BACKGROUND

• Vinograd AM, Chen AE, Woodford AL, Fesnak S, Gaines S, Elci OU, Zorc JJ. Ultrasonographic Guidance to Improve First-Attempt Success in Children With Predicted Difficult Intravenous Access in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jul;74(1):19-27. doi: 10.1016/j.annemergmed.2019.02.019. Epub 2019 May 22.

  PMID: 31126618 DERIVED

Study Officials

• Joseph J Zorc, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

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: April 24, 2014
• First Posted: April 29, 2014
• Study Start: May 1, 2014
• Primary Completion: December 2, 2016
• Study Completion: March 1, 2017
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

US (1)