Use of Ultrasound Guidance to Facilitate Obtaining Peripheral Intravenous Access

Use of Ultrasound Guidance to Facilitate Insertion of Peripheral Intravenous Catheter in Pediatric Patients

The purpose of this study is to determine if the use of ultrasound guidance to insert peripheral intravenous catheters will decrease the number of punctures required to successful insertion. The hypothesis is that fewer attempts will be required with the use of ultrasound potentially leading to preservation of vessels, decreased patient pain scores and increased patient/parent satisfaction.

Study Overview

Detailed Description

Patients with known or current difficult venous access will be referred to the Vascular Access Team for peripheral intravenous catheter insertion. The Vascular Access Team will randomize patients to ultrasound guidance or non-ultrasound guidance for placement of the peripheral intravenous catheter.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients 0-17 years of age requiring peripheral intravenous access
  • have not had PIV attempt in preceding 24 hours

Exclusion Criteria:

  • patients who are medically unstable
  • patients who require emergent intravenous access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ultrasound guidance
Ultrasound guidance used to facilitate insertion of PIV catheter.
Ultrasound guidance used to facilitate insertion of PIV catheter
ACTIVE_COMPARATOR: Non-ultrasound guidance
Ultrasound guidance will not be used for insertion of PIV catheter.
Ultrasound guidance will not be used for insertion of PIV catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of attempts to successful peripheral intravenous access cannulation.
Time Frame: 1 time - baseline visit
1 time - baseline visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient pain score rating for PIV access attempt.
Time Frame: 1 time - baseline visit
1 time - baseline visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent satisfaction with child's PIV access experience.
Time Frame: 1 time - baseline visit
1 time - baseline visit
PIV extravasations.
Time Frame: 1 time - baseline visit
Cincinnati Children's Hospital has an initiative to reduce the number of PIV extravasations. The investigators will measure the number of extravasations in the study participants to determine if ultrasound guidance has an effect on this number.
1 time - baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sharon A Dwyer, ADN, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

May 3, 2021

First Posted (ACTUAL)

May 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • CIN001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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