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

This study has been terminated.
(Funding Stopped)
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00914069
First received: June 1, 2009
Last updated: March 2, 2017
Last verified: March 2017
June 1, 2009
March 2, 2017
June 2009
July 2013   (Final data collection date for primary outcome measure)
  • 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.
First attempt IV success rate, time of procedure [ Time Frame: Immediate peri-procedure ]
Complete list of historical versions of study NCT00914069 on ClinicalTrials.gov Archive Site
  • 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.
Number of attempts required to complete a successful IV start [ Time Frame: Immediate peri-procedure ]
Not Provided
Not Provided
 
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Vascular Access Complication
  • Device: RIVS vascular access
    Access to peripheral vasculature
  • Device: Conventional vascular access
    Vascular access using conventional venous access device
  • Experimental: RIVS vascular access
    RIVS vascular access
    Intervention: Device: RIVS vascular access
  • Active Comparator: Conventional vascular access
    Conventional vascular access
    Intervention: Device: Conventional vascular access
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
175
August 2013
July 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
5 Years to 90 Years   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00914069
62009123
Yes
Not Provided
Plan to Share IPD: No
C. R. Bard
C. R. Bard
Not Provided
Principal Investigator: Jeffrey S Stuart, MD Washington Outpatient Surgery Center
C. R. Bard
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP