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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vascular Access Complication

Intervention / Treatment
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* Device: RIVS vascular access
* Device: Conventional vascular access


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIVS vascular access<br>RIVS vascular access | Device: RIVS vascular access<br>* Access to peripheral vasculature<br>|
| Active Comparator: Conventional vascular access<br>Conventional vascular access | Device: Conventional vascular access<br>* Vascular access using conventional venous access device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Post-PIV placement until catheter removal (usually within 4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Required to Obtain Access | A secured flushed IV will be indicative of a successful PIV placement. | 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. | 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. | Post-PIV placement until catheter removal (usually within 4 days) |