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

C. R. Bard

Status: Completed

Conditions: Vascular Access Complication

Treatments: Device: Conventional IV Catheter Device; Device: AccuCath IV Catheter Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01943474

DDVP-001/VPW-STP-00004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

AccuCath IV Catheter Device

Experimental group

Description:

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

Treatment:

Device: AccuCath IV Catheter Device

Conventional IV Catheter Device

Active Comparator group

Description:

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

Treatment:

Device: Conventional IV Catheter Device