Ultrasound Guided IV Access in a Pediatric Emergency Department

NCT ID: NCT02125552

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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The proposed study is a randomized trial of ultrasound guided IV access compared to traditional IV access in patients determined to have difficult IV access based on the Difficult Intravenous Access (DIVA) scale. Patients enrolled in the study will be randomized to traditional IV access or ultrasound guided IV access. If randomized to ultrasound guided IV access, the IV will be placed under direct visualization. Following IV placement or when attempts at IV access have ceased, the patient and family will be asked to complete a series of questions related to their satisfaction regarding IV placement. The follow-up phase examining duration of the IV and any related complications will continue until the IV placed as part of the study has been removed.

Conditions

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Difficult Intravenous Access in Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound guided intravenous access

This group will have their IV placed by ultrasound guidance.

Group Type EXPERIMENTAL

Ultrasound guidance

Intervention Type PROCEDURE

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

Traditional intravenous access

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

Group Type PLACEBO_COMPARATOR

Traditional intravenous access

Intervention Type PROCEDURE

Placement by experienced nurse using standard IV techniques

Interventions

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Ultrasound guidance

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

Intervention Type PROCEDURE

Traditional intravenous access

Placement by experienced nurse using standard IV techniques

Intervention Type PROCEDURE

Other Intervention Names

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Standard of Care arm

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph J Zorc, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10429137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9652275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18347490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22092893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19262420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10577399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22795988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19836193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20006193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22409596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23415740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19561750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17591303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19371518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16271677 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 14651305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19912132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17392522 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31126618 (View on PubMed)

Other Identifiers

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13-010758

Identifier Type: -

Identifier Source: org_study_id

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