AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use

NCT ID: NCT01943474

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-10-31

Brief Summary

The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to conventional IV catheters.

Detailed Description

This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.

Conditions

Vascular Access Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AccuCath IV Catheter Device

AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal

Group Type: EXPERIMENTAL

AccuCath IV Catheter Device

Intervention Type: DEVICE

Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.

Conventional IV Catheter Device

Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal

Group Type: ACTIVE_COMPARATOR

Conventional IV Catheter Device

Intervention Type: DEVICE

Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.

Interventions

AccuCath IV Catheter Device

Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.

Intervention Type: DEVICE

Conventional IV Catheter Device

Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.

Intervention Type: DEVICE

Other Intervention Names

Rapid Intravascular Start System (RIVS); AccuCath System; AccuCath IV device; AccuCath; AccuCath PIV; AccuCath Short IV; AccuCath IV Catheter; Insyte Autoguard; Insyte Autoguard PIV; Insyte Autoguard IV Catheter; Insyte Autoguard IV device

Eligibility Criteria

Inclusion Criteria

1. Male or female, age ≥ 18 years or ≤ 89 years old;

2. Capable and willing to give informed consent;

3. English speaking;

4. Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;

5. Admitted to study inpatient unit.

Exclusion Criteria

1. Male or female, < 18 years old or > 89 years old;

2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);

3. Previous venous grafts or surgery at the target vessel access site;

4. Currently involved in other investigational clinical trials (unless permission is granted by other study principal investigator [PI]);

5. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Rowbottom, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Bette Idemoto, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

DDVP-001/VPW-STP-00004

Identifier Type: -

Identifier Source: org_study_id