RecruitingNot ApplicableNCT06107361

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


Sponsor

Corewell Health East

Enrollment

360 participants

Start Date

Nov 7, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • ≥ 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
  • 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.

Exclusion Criteria2

  • \<18 years old Restricted mobility of elbow joint Cognitively impaired. Skin complications that limit access to the potential IV site
  • None

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Interventions

DEVICEB. Braun 6.35cm 20 gauge ultralong intravenous catheter

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

DEVICEBD 5.71 cm 20 gauge Accucath

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


Locations(1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

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NCT06107361