Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival

NCT06107361 | Recruiting FDA Device

• 1 other identifier: 2023-221
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, parallel, non-blinded, two-arm randomized controlled trial of intravenous catheter failure evaluating the impact of a built-in guide wire. The objective of this study is to demonstrate that the control ultralong intravenous catheter (IV) without the guide wire is non-inferior to the experimental catheter with the guide wire. After obtaining consent, eligible patients will be randomly allocated to control Arm 1 (ultralong intravenous catheter) or experimental Arm 2 (ultralong intravenous catheter with guide wire) in a ratio of 1:1 via a computer-generated randomization schedule. The participants will be followed to collect data until the catheter is removed.

Conditions

Intravenous Infection; Peripheral Intravenous Vein Catheter Phlebitis

Keywords

PIV; BBraun Ultra Long Catheter; BD Accucath; Phlebitis; IV infection; peripheral intravenous

Outcome Measures

Primary Outcomes (3)

• Survival of the BBraun 6.35 centimeter 20 gauge ultralong intravenous catheter compared to the BD 5.71 cm 20 gauge ultralong intravenous catheter with guide wire

  Survival of catheter will be measured in hours from time of insertion to time of removal or failure. Functionality is defined as being able to aspirate blood and/or flush without resistance with 3-5 milliliters of saline. If unable, the catheter is considered to have failed.

  up to 15 days or the duration of the IV catheter

• Time to insertion

  Time to insertion(measured in minutes). Time to insertion is defined as needlestick to dressing application.

  First day of hospitalization

• First-stick success rate

  Number of patients with only one puncture of skin to achieve venous access

  First day of hospitalization

Secondary Outcomes (3)

• Cost for all vascular needs during hospitalization

  up to 15 days or the duration of the IV catheter

• Catheter Associated Thrombosis

  up to 30 days post discharge

• Catheter Associated bloodstream infection

  up to 30 days post discharge

Study Arms (2)

Arm 1 (6.35cm 20 gauge ultralong intravenous catheter)

ACTIVE COMPARATOR

Arm 1 Device: B. Braun 6.35cm 20 gauge ultralong intravenous catheter

Device: B. Braun 6.35cm 20 gauge ultralong intravenous catheter

Arm 2 (5.71 cm 20 gauge Accucath)

EXPERIMENTAL

Arm 2 Device: BD 5.71 cm 20 gauge Accucath, ultralong intravenous catheter with guide wire

Device: BD 5.71 cm 20 gauge Accucath

Interventions

B. Braun 6.35cm 20 gauge ultralong intravenous catheter DEVICE

B Braun Medical Inc, 6.35cm 20 gauge ultralong intravenous catheter

Arm 1 (6.35cm 20 gauge ultralong intravenous catheter)

BD 5.71 cm 20 gauge Accucath DEVICE

Bard Access Systems, Inc, BD 5.71 cm 20 gauge ultralong intravenous catheter with guide wire

Arm 2 (5.71 cm 20 gauge Accucath)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ than 18 years old Vascular Access Score of 4 or 5
• Vascular Access Score:
• Visible with distention and easily palpable
• Visible and easily palpable
• Not visible and easily palpable
• Visible and poorly palpable
• Not visible and poorly or non-palpable

You may not qualify if:

• \<18 years old Restricted mobility of elbow joint Cognitively impaired. Skin complications that limit access to the potential IV site
• Clinician working in the emergency department at Corewell Health William Beaumont University Hospital (physician, advanced practice provider, nurse, technician) Competency in Operation STICK, which is an vascular access training program.
• None

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

RECRUITING

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• Amit Bahl, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Bahl, MD

CONTACT

248-898-9111; amit.bahl@corewellhealth.org

Maureen Cooney, RN

CONTACT

248-551-0099; maureen.cooney@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Emergency Medicine Ultrasound

Model Details: This is a prospective, parallel, non-blinded, two-arm randomized (like the flip of a coin) controlled trial of catheter failure evaluating the impact of a built-in guide wire. This study plans to enroll 360 participants (two equally sized groups of 180 participants in each arm)

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 7, 2023
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)