Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire

The purpose of this study is to compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided peripheral IV placement with modified seldinger technique using a guidewire.

Study Overview

• Status: Completed
• Conditions: Difficult Peripheral IV Access
• Intervention / Treatment: Device: Ultrasound guided peripheral IV placement

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Difficult peripheral IV access (2 failed attempts by nursing staff)
• Prior history of difficult IV access and patient request for ultrasound guided IV

Exclusion Criteria:

• Need for emergent access or central venous access
• Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; Standard of care ultrasound guided peripheral IV placement
Experimental: Experimental; Ultrasound guided peripheral IV placement with the use of a guidewire	Device: Ultrasound guided peripheral IV placement; Accucath™ 20 Gax 5.7cm catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate	First attempt success is defined as ability to place and use the catheter after only one attempt and will be reported by study staff.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall success rate	Overall success is defined as ability to place and use the catheter (after 2 or fewer attempts) and will be reported by study staff.	60 minutes
Number of skin punctures	Number of skin punctures will be recorded by study staff.	60 minutes
Complications including hematoma, IV infiltration, catheter dislodge	Patients will be monitored for complications of IV placement by study staff	3 days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Heidi Kimberly, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimate): April 21, 2015

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2015P000073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO