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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-08-31

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.

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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.

Conditions

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Vascular Access Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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RIVS vascular access

Group Type EXPERIMENTAL

RIVS vascular access

Intervention Type DEVICE

Access to peripheral vasculature

Conventional vascular access

Group Type ACTIVE_COMPARATOR

Conventional vascular access

Intervention Type DEVICE

Vascular access using conventional venous access device

Interventions

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RIVS vascular access

Access to peripheral vasculature

Intervention Type DEVICE

Conventional vascular access

Vascular access using conventional venous access device

Intervention Type DEVICE

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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes