Ultrasound Guided IV Access in a Pediatric Emergency Department

Difficult Intravenous Access in Pediatrics Clinical Trial

— USgIV  

Official title:

A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125552
• Other study ID #: 13-010758
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2018
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 2017
• Est. primary completion date: December 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Intravenous Access in Pediatrics
• Emergencies

Intervention

Procedure:
• Ultrasound guidance
The ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group
• Traditional intravenous access
Placement by experienced nurse using standard IV techniques

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: J Intraven Nurs 1998 Jul-Aug;21(4):220. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measure the overall number of IV attempts..	We will record the number of IV attempts made until a patient has a successfully placed IV or further attempts are aborted.	Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Secondary	Time to IV access.	The time from enrollment until successful IV access is obtained will be measured.	Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Secondary	Patient & family satisfaction with IV placement method.	A survey will be given to parents and patients over age 12 years to ask them about their experience with the IV placement.	Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Secondary	Compare the survival (in length of time) of IV access	We will track the IVs placed as part of the study through the electronic medical record to determine when and why they were removed and if there were any associated complications.	Participants will be followed through the duration of hospital stay, expected average of 5 days