AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)

C. R. Bard

Status: Completed

Conditions: Vascular Access Complication

Treatments: Device: AccuCath Intravenous Catheter System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01937195

VPW-STP-00002

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 (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.

Full description

Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.

Enrollment: 95 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age > or equal to 18 years or < or equal to 89 years old;
2. Capable and willing to give informed consent;
3. English speaking;
4. Acceptable candidate for an elective, non-emergent PIV 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 PI);
5. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

AccuCath Intravenous Catheter System

Experimental group

Description:

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

Treatment:

Device: AccuCath Intravenous Catheter System