Evaluating the Role of the Guidewire in Peripheral Intravenous Access

NCT04949854 | Withdrawn FDA Device

• 1 other identifier: 2021-049
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to demonstrate that the control ultralong intravenous catheter without the guide wire is equivalent to the experimental catheter with the guide wire. The hypothesis of this study is that the 6.35 cm 20G ultralong Ultrasound Guided Peripheral Intravenous (USPIV) will have no difference in survival compared to the 5.71 cm ultralong with wire USPIV.

Conditions

Peripheral Intravenous Vein Catheter Phlebitis; Intravenous Infection

Keywords

PIV; BBraun Ultra Long Catheter; BD Accucath; Phlebitis; IV Infection

Outcome Measures

Primary Outcomes (1)

• Catheter survival

  Survival in hours or days of the catheter will be evaluated by functionality of catheter for intravenous therapy prior to patient discharge. The event of interest is failure of functionality identified during follow-up assessment during hospitalization.

  During hospitalization, up to 60 days

Secondary Outcomes (6)

• First-stick success.

  First day of hospitalization

• Time to insertion

  First day of hospitalization

• Provider proficiency

  Study period, a maximum of 1 year

• Total cost for all vascular access needs during hospitalization.

  During hospitalization, up to 60 days

• Catheter-associated thrombosis

  During hospitalization, up to 60 days

Other Outcomes (1)

• Inflammatory complications by clinical assessment

  During hospitalization, up to 60 days

Study Arms (2)

Control Arm B.Braun 6.35 cm 20 Gauge catheter

ACTIVE COMPARATOR

Device 6.35 cm 20 Gauge B. Braun catheter without guidewire

Device: B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter

Experimental Arm B.D. Accucath 5.71 cm 20 Gauge catheter

EXPERIMENTAL

Device BD 5.71 cm Accucath IV catheter with guidewire

Device: B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter

Interventions

B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter DEVICE

control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire

Control Arm B.Braun 6.35 cm 20 Gauge catheter

B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter DEVICE

Experimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire

Experimental Arm B.D. Accucath 5.71 cm 20 Gauge catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Eligible patients must be: 1. ≥ than 18 years old 2. Vascular Access Score 4 or 5. Clinicians Eligibility Criteria: 1. Clinician working in the emergency room (physician, advanced practice provider, nurse, technician) OR clinician working on the inpatient vascular access team (advanced practice provider, nurse) 2. Greater than 6 months experience in ultrasound guided IV insertions Patients are excluded: 1. \<18 years old 2. Restricted mobility of elbow joint 3. Cognitively impaired

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• Amit Bahl, MD.

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, parallel, non-blinded, two-arm randomized (like the flip of a coin) controlled trial of catheter failure evaluating the impact of a built-in guide wire. This study plans to enroll 360 participants (two equally sized groups of 180 participants in each arm).

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: July 2, 2021
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)