Recruiting

Ultrasound-Guided Catheter

Sponsor:

Corewell Health East

Code:

NCT06107361

Conditions

Peripheral Intravenous Vein Catheter Phlebitis

Intravenous Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

B. Braun 6.35cm 20 gauge ultralong intravenous catheter

BD 5.71 cm 20 gauge Accucath

Study Details

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

Peripheral Intravenous Vein Catheter Phlebitis

Intravenous Infection

Study ID

NCT06107361

Start date

Nov 7, 2023

Status verified date

Jun, 2026

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Participants Inclusion Criteria:

≥ than 18 years old Vascular Access Score of 4 or 5

Vascular Access Score:

1. Visible with distention and easily palpable
2. Visible and easily palpable
3. Not visible and easily palpable
4. Visible and poorly palpable
5. Not visible and poorly or non-palpable

Study participants exclusion criteria:

<18 years old Restricted mobility of elbow joint Cognitively impaired. Skin complications that limit access to the potential IV site

Clinician Participants Inclusion Criteria:

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.

Clinician participants exclusion criteria:

None

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

B. Braun 6.35cm 20 gauge ultralong intravenous catheter

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

BD 5.71 cm 20 gauge Accucath

Bard Access Systems, Inc, BD 5.71 cm 20 gauge 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 ]
  • Time to insertion [ Time Frame: First day of hospitalization ]
  • First-stick success rate [ Time Frame: First day of hospitalization ]

Central Contacts and Locations

Central contacts

Amit Bahl, MD

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

Maureen Cooney, RN

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

Locations

Beaumont Hospital - Royal Oak

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Amit Bahl, MD

2488989111amit.bahl@corewellhealth.org

More Information

Sponsor

Corewell Health East

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corewell Health East on 2026-06-10.