Ultrasound Guided IV Access in a Pediatric Emergency Department

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Difficult Intravenous Access in Pediatrics

Intervention / Treatment
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* Procedure: Ultrasound guidance
* Procedure: Traditional intravenous access


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided intravenous access<br>This group will have their IV placed by ultrasound guidance. | Procedure: Ultrasound guidance<br>* The ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group<br>|
| Placebo Comparator: Traditional intravenous access<br>The patients randomized to traditional IV access will have their IVs placed by standard technique. | Procedure: Traditional intravenous access<br>* Placement by experienced nurse using standard IV techniques<br>* Other names: Standard of Care arm;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular access device, ultrasonography