Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter

C. R. Bard

Status

Terminated

Conditions

Vascular Access Complication

Treatments

Device: Conventional vascular access

Device: RIVS vascular access

Study type

Interventional

Funder types

Industry

Identifiers

NCT00914069

62009123

Details and patient eligibility

About

The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.

Full description

The hypothesis to be statistically tested was that the RIVS system will have a higher rate of successful first attempt peripheral intravenous placement success as compared to conventional peripheral intravenous catheters without a significant increase in device related complications and procedure time.

Enrollment

175 patients

Sex

All

Ages

5 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Any type of oncology patients undergoing chemotherapy or post-chemotherapy (without a port/cannula), or over 65 years
Requires peripheral IV as determined by examining physician
Requires the IV when a study nurse or resident is available
Able to sign an informed consent

Exclusion Criteria

Active systemic or cutaneous infection or inflammation;
Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline International Normalized Ratio (INR) ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
Currently involved in any other investigational clinical trials;
Previous vascular grafts or surgery at the target vessel access site;
Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
Central line available
Requirement for immediate IV placement (patient's condition would potentially be compromised if there is a time delay in IV placement)