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.

Study Overview

• Status: Terminated
• Conditions: Vascular Access Complication
• Intervention / Treatment: Device: RIVS vascular access; Device: Conventional vascular access

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Washington Outpatient Surgery Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospital Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIVS vascular access	Device: RIVS vascular access; Access to peripheral vasculature
Active Comparator: Conventional vascular access	Device: Conventional vascular access; Vascular access using conventional venous access device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt	A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement.	An access attempt usually ranges from 0 to 45 minutes in duration.
Summary of Major Complications	Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others.	Post-PIV placement until catheter removal (usually within 4 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Required to Obtain Access	A secured flushed IV will be indicative of a successful PIV placement.	An access attempt usually ranges from 0 to 45 minutes in duration.
Second Stick Success Rate	A secured flushed IV will be indicative of a successful PIV placement.	An access attempt usually ranges from 0 to 45 minutes in duration.
Summary of Minor Complications	Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.	Post-PIV placement until catheter removal (usually within 4 days)

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Jeffrey S Stuart, MD, Washington Outpatient Surgery Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 62009123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO