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Completed

NCT Number: NCT02125552

Ultrasound Guided IV Access in a Pediatric Emergency Department

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.

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Key information

Conditions

Difficult Intravenous Access in Pediatrics

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guidance

Procedure

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

Traditional intravenous access

Procedure

Placement by experienced nurse using standard IV techniques

Other names: Standard of Care arm

Primary outcomes

  1. 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

  1. Measure the overall number of IV attempts..

    Time frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours

    We will record the number of IV attempts made until a patient has a successfully placed IV or further attempts are aborted.

  2. Time to IV access.

    Time frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours

    The time from enrollment until successful IV access is obtained will be measured.

  3. Patient & family satisfaction with IV placement method.

    Time frame: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours

    A survey will be given to parents and patients over age 12 years to ask them about their experience with the IV placement.

  4. Compare the survival (in length of time) of IV access

    Time frame: Participants will be followed through the duration of hospital stay, expected average of 5 days

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Acronym: USgIV

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 29, 2014
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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