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

Evaluation of the Safety and Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter for Peripheral Intravenous (PIV) Insertion in Children, Oncology Patients and Elderly: a Controlled Randomized Trial

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.

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.

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)