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Ultrasound Guided IV Access in a Pediatric Emergency Department

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02125552
Acronym
USgIV
Enrollment
163
Registered
2014-04-29
Start date
2014-05-31
Completion date
2017-03-31
Last updated
2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Intravenous Access in Pediatrics

Keywords

vascular access device, ultrasonography

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.

Interventions

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

PROCEDURETraditional intravenous access

Placement by experienced nurse using standard IV techniques

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success of Initial IV Placement AttemptParticipants will be followed through the duration of emergency department stay, an expected average of 4 hoursPatients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment. The IV will be placed directly following enrollment.

Secondary

MeasureTime frameDescription
Measure the overall number of IV attempts..Participants will be followed through the duration of emergency department stay, an expected average of 4 hoursWe 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.Participants will be followed through the duration of emergency department stay, an expected average of 4 hoursThe time from enrollment until successful IV access is obtained will be measured.
Patient & family satisfaction with IV placement method.Participants will be followed through the duration of emergency department stay, an expected average of 4 hoursA 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 accessParticipants will be followed through the duration of hospital stay, expected average of 5 daysWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026