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

Primary Purpose

Difficult Intravenous Access in Pediatrics

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound guidance
Traditional intravenous access
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Difficult Intravenous Access in Pediatrics focused on measuring vascular access device, ultrasonography

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ultrasound guided intravenous access

Traditional intravenous access

Arm Description

This group will have their IV placed by ultrasound guidance.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2014
Last Updated
May 10, 2018
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT02125552
Brief Title
Ultrasound Guided IV Access in a Pediatric Emergency Department
Acronym
USgIV
Official Title
A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2, 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult Intravenous Access in Pediatrics
Keywords
vascular access device, ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided intravenous access
Arm Type
Experimental
Arm Description
This group will have their IV placed by ultrasound guidance.
Arm Title
Traditional intravenous access
Arm Type
Placebo Comparator
Arm Description
The patients randomized to traditional IV access will have their IVs placed by standard technique.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guidance
Intervention Description
The ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group
Intervention Type
Procedure
Intervention Name(s)
Traditional intravenous access
Other Intervention Name(s)
Standard of Care arm
Intervention Description
Placement by experienced nurse using standard IV techniques
Primary Outcome Measure Information:
Title
Success of Initial IV Placement Attempt
Description
Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment. The IV will be placed directly following enrollment.
Time Frame
Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Secondary Outcome Measure Information:
Title
Measure the overall number of IV attempts..
Description
We will record the number of IV attempts made until a patient has a successfully placed IV or further attempts are aborted.
Time Frame
Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Title
Time to IV access.
Description
The time from enrollment until successful IV access is obtained will be measured.
Time Frame
Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Title
Patient & family satisfaction with IV placement method.
Description
A survey will be given to parents and patients over age 12 years to ask them about their experience with the IV placement.
Time Frame
Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
Title
Compare the survival (in length of time) of IV access
Description
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.
Time Frame
Participants will be followed through the duration of hospital stay, expected average of 5 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph J Zorc, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
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Ultrasound Guided IV Access in a Pediatric Emergency Department

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