Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
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|ClinicalTrials.gov Identifier: NCT00914069|
Recruitment Status : Terminated (Funding Stopped)
First Posted : June 4, 2009
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Vascular Access Complication||Device: RIVS vascular access Device: Conventional vascular access||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914069
|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|
|Principal Investigator:||Jeffrey S Stuart, MD||Washington Outpatient Surgery Center|