Clinical trial NCT00914069: Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Access Complication
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 175
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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)

Primary outcomes:
measure: IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt
timeFrame: An access attempt usually ranges from 0 to 45 minutes in duration.
measure: Summary of Major Complications
timeFrame: Post-PIV placement until catheter removal (usually within 4 days)
Secondary outcomes:
measure: Time Required to Obtain Access
timeFrame: An access attempt usually ranges from 0 to 45 minutes in duration.
measure: Second Stick Success Rate
timeFrame: An access attempt usually ranges from 0 to 45 minutes in duration.
measure: Summary of Minor Complications
timeFrame: Post-PIV placement until catheter removal (usually within 4 days)
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Washington Outpatient Surgery Center
state: California
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
Study officials:
affiliation: Washington Outpatient Surgery Center
name: Jeffrey S Stuart, MD
role: PRINCIPAL_INVESTIGATOR
References: