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

Not Applicable

Terminated

• Conditions: Vascular Access Complication
• Interventions: Device: RIVS vascular access; Device: Conventional vascular access

• Registration Number: NCT00914069
• Lead Sponsor: C. R. Bard

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Results First Submitted: 2016-11-14
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Results First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIVS vascular access	RIVS vascular access	RIVS vascular access
Conventional vascular access	Conventional vascular access	Conventional vascular access

Primary Outcome Measures

Name	Time	Method
IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt	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.
Summary of Major Complications	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

Name	Time	Method
Time Required to Obtain Access	An access attempt usually ranges from 0 to 45 minutes in duration.	A secured flushed IV will be indicative of a successful PIV placement.
Second Stick Success Rate	An access attempt usually ranges from 0 to 45 minutes in duration.	A secured flushed IV will be indicative of a successful PIV placement.
Summary of Minor Complications	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.

Trial Locations

Locations (3)

St. Vincent's Medical Center; 🇺🇸 Jacksonville, Florida, United States

Washington Outpatient Surgery Center; 🇺🇸 Fremont, California, United States

University Hospital Case Medical Center; 🇺🇸 Cleveland, Ohio, United States