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

Vascular Access Complication Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00914069
• Other study ID #: 62009123
• Status: Terminated
• Phase: N/A
• First received: June 1, 2009
• Last updated: June 13, 2016
• Start date: June 2009
• Est. completion date: August 2013

Study information

• Verified date: June 2016
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 90 Years

Eligibility

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 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Vascular Access Complication

Intervention

Device:
• RIVS vascular access
Access to peripheral vasculature
• Conventional vascular access
Vascular access using conventional venous access device

Locations

Country	Name	City	State
United States	University Hospital Case Medical Center	Cleveland	Ohio
United States	Washington Outpatient Surgery Center	Fremont	California
United States	St. Vincent's Medical Center	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt IV success rate, time of procedure		Immediate peri-procedure	No
Secondary	Number of attempts required to complete a successful IV start		Immediate peri-procedure	No