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Clinical Trials/NCT02125552
NCT02125552
Completed
Not Applicable

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

Children's Hospital of Philadelphia1 site in 1 country163 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Difficult Intravenous Access in Pediatrics
Sponsor
Children's Hospital of Philadelphia
Enrollment
163
Locations
1
Primary Endpoint
Success of Initial IV Placement Attempt
Status
Completed
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
March 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (1)

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