Ultrasound Guided IV Access in a Pediatric Emergency Department (USgIV)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Difficult Intravenous Access in Pediatrics

Treatments: Procedure: Ultrasound guidance; Procedure: Traditional intravenous access

Study type: Interventional

Funder types: Other

Identifiers

NCT02125552

13-010758

Details and patient eligibility

About

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 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.

Enrollment: 163 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups, including a placebo group

Ultrasound guided intravenous access

Experimental group

Description:

This group will have their IV placed by ultrasound guidance.

Treatment:

Procedure: Ultrasound guidance

Traditional intravenous access

Placebo Comparator group

Description:

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

Treatment:

Procedure: Traditional intravenous access