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

NCT06107361 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-01-16

No results posted yet for this study

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

  • Peripheral Intravenous Vein Catheter Phlebitis
  • Intravenous Infection

Interventions

DEVICE

B. Braun 6.35cm 20 gauge ultralong intravenous catheter

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

DEVICE

BD 5.71 cm 20 gauge Accucath

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

Sponsors & Collaborators

  • Corewell Health East

    lead OTHER

Principal Investigators

  • Amit Bahl, MD · Corewell Health East

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2026-03-31
Completion
2026-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06107361 on ClinicalTrials.gov