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

• ClinicalTrials.gov Identifier: NCT00914069
• Recruitment Status: Terminated
• First Posted: June 4, 2009
• Results First Posted: April 13, 2017
• Last Update Posted: April 13, 2017
• Sponsor: C. R. Bard
• Information provided by (Responsible Party): C. R. Bard

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vascular Access Complication	Device: RIVS vascular access; Device: Conventional vascular access	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 175 participants
• 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
• Study Start Date: June 2009
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 90 Years (Child, Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 62009123
• First Posted: June 4, 2009
• 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