Ultrasound Guided IV Access in a Pediatric Emergency Department

Overview

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.

Full Title of Study: “A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 2, 2016

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

• Experimental: Ultrasound guided intravenous access
  • This group will have their IV placed by ultrasound guidance.
• Placebo Comparator: Traditional intravenous access
  • The patients randomized to traditional IV access will have their IVs placed by standard technique.

Clinical Trial Outcome Measures

Primary Measures

• Success of Initial IV Placement Attempt
  • Time Frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
  • Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment. The IV will be placed directly following enrollment.

Secondary Measures

• Measure the overall number of IV attempts..
  • Time Frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
  • We will record the number of IV attempts made until a patient has a successfully placed IV or further attempts are aborted.
• Time to IV access.
  • Time Frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
  • The time from enrollment until successful IV access is obtained will be measured.
• Patient & family satisfaction with IV placement method.
  • Time Frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
  • A survey will be given to parents and patients over age 12 years to ask them about their experience with the IV placement.
• Compare the survival (in length of time) of IV access
  • Time Frame: Participants will be followed through the duration of hospital stay, expected average of 5 days
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Children’s Hospital of Philadelphia
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Joseph J Zorc, MD, MSCE, Principal Investigator, Children’s Hospital of Philadelphia

References

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