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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ ≥ 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.

Locations
United States
Michigan
Beaumont Hospital - Royal Oak
RECRUITING
Royal Oak
Contact Information
Primary
Amit Bahl, MD
amit.bahl@corewellhealth.org
248-898-9111
Backup
Maureen Cooney, RN
maureen.cooney@corewellhealth.org
248-551-0099
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2026-05
Participants
Target number of participants: 360
Treatments
Active_comparator: Arm 1 (6.35cm 20 gauge ultralong intravenous catheter)
Arm 1 Device: B. Braun 6.35cm 20 gauge ultralong intravenous catheter
Experimental: Arm 2 (5.71 cm 20 gauge Accucath)
Arm 2 Device: BD 5.71 cm 20 gauge Accucath, ultralong intravenous catheter with guide wire
Related Therapeutic Areas
Sponsors
Leads: William Beaumont Hospitals

This content was sourced from clinicaltrials.gov