Clinical trial NCT02125552: Ultrasound Guided IV Access in a Pediatric Emergency Department
Official title: A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intravenous Access in Pediatrics
Keywords: vascular access device
ultrasonography
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 163
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Success of Initial IV Placement Attempt
timeFrame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Secondary outcomes:
measure: Measure the overall number of IV attempts..
timeFrame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
measure: Time to IV access.
timeFrame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
measure: Patient & family satisfaction with IV placement method.
timeFrame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
measure: Compare the survival (in length of time) of IV access
timeFrame: Participants will be followed through the duration of hospital stay, expected average of 5 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Joseph J Zorc, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
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