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

C. R. Bard175 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

175

Conditions

Vascular Access Complication

Interventions

RIVS vascular accessDEVICE

Access to peripheral vasculature

Conventional vascular accessDEVICE

Vascular access using conventional venous access device

Eligibility

Sex: ALLMin age: 5 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (3)

Washington Outpatient Surgery Center

Fremont, California, United States

St. Vincent's Medical Center

Jacksonville, Florida, United States

University Hospital Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt

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.

Time frame: An access attempt usually ranges from 0 to 45 minutes in duration.

Summary of Major Complications

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.

Time frame: Post-PIV placement until catheter removal (usually within 4 days)

Secondary Outcomes

Time Required to Obtain Access

A secured flushed IV will be indicative of a successful PIV placement.

Time frame: An access attempt usually ranges from 0 to 45 minutes in duration.

Second Stick Success Rate

A secured flushed IV will be indicative of a successful PIV placement.

Time frame: An access attempt usually ranges from 0 to 45 minutes in duration.

Summary of Minor Complications

Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.

Time frame: Post-PIV placement until catheter removal (usually within 4 days)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.