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

NCT00914069 | Terminated Results DMC

• 1 other identifier: 62009123
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Vascular Access Complication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Time Required to Obtain Access

  An access attempt usually ranges from 0 to 45 minutes in duration.

• Second Stick Success Rate

  An access attempt usually ranges from 0 to 45 minutes in duration.

• Summary of Minor Complications

  Post-PIV placement until catheter removal (usually within 4 days)

Study Arms (2)

RIVS vascular access

EXPERIMENTAL

RIVS vascular access

Device: RIVS vascular access

Conventional vascular access

ACTIVE COMPARATOR

Conventional vascular access

Device: Conventional vascular access

Interventions

RIVS vascular access DEVICE

Access to peripheral vasculature

RIVS vascular access

Conventional vascular access DEVICE

Vascular access using conventional venous access device

Conventional vascular access

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (3)

Washington Outpatient Surgery Center

Fremont, California, 94538, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

University Hospital Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Results Point of Contact

• Title: Gina Gilbert
• Organization: Bard Access Systems, Inc.

Gina.Gilbert@crbard.com

407-489-0835

Study Officials

• Jeffrey S Stuart, MD

  Washington Outpatient Surgery Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 4, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)