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

This study has been terminated.
(Funding Stopped)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914069
First Posted: June 4, 2009
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C. R. Bard
  Purpose
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.

Condition Intervention
Vascular Access Complication Device: RIVS vascular access Device: Conventional vascular access

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt [ Time Frame: An access attempt usually ranges from 0 to 45 minutes in duration. ]
    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.

  • Summary of Major Complications [ Time Frame: Post-PIV placement until catheter removal (usually within 4 days) ]
    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.


Secondary Outcome Measures:
  • Time Required to Obtain Access [ Time Frame: An access attempt usually ranges from 0 to 45 minutes in duration. ]
    A secured flushed IV will be indicative of a successful PIV placement.

  • Second Stick Success Rate [ Time Frame: An access attempt usually ranges from 0 to 45 minutes in duration. ]
    A secured flushed IV will be indicative of a successful PIV placement.

  • Summary of Minor Complications [ Time Frame: Post-PIV placement until catheter removal (usually within 4 days) ]
    Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.


Enrollment: 175
Study Start Date: June 2009
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RIVS vascular access
RIVS vascular access
Device: RIVS vascular access
Access to peripheral vasculature
Active Comparator: Conventional vascular access
Conventional vascular access
Device: Conventional vascular access
Vascular access using conventional venous access device

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914069


Locations
United States, California
Washington Outpatient Surgery Center
Fremont, California, United States, 94538
United States, Florida
St. Vincent's Medical Center
Jacksonville, Florida, United States, 32204
United States, Ohio
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Jeffrey S Stuart, MD Washington Outpatient Surgery Center
  More Information

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00914069     History of Changes
Other Study ID Numbers: 62009123
First Submitted: June 1, 2009
First Posted: June 4, 2009
Results First Submitted: November 14, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No