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

Conditions

• Intravenous Infection
• Peripheral Intravenous Vein Catheter Phlebitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• B. Braun 6.35cm 20 gauge ultralong intravenous catheter — DEVICE
  B Braun Medical Inc, 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

Study Details

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.

Key Dates

Start date

Nov 7, 2023

Status verified

Jun 2026

Primary completion

Jun 30, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• 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

Primary Outcome Measure

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 [ Time Frame: up to 15 days or the duration of the IV catheter ]

Central Contacts

• Amit Bahl, MD
  248-898-9111
  [email protected]
• Maureen Cooney, RN
  248-551-0099
  [email protected]

Locations (1)

Find similar trials in Royal Oak, MI