Clinical Trial: Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids

Brief Summary: The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.

Detailed Summary:
Sponsor: ivWatch, LLC

Current Primary Outcome: Test performance of optical device for monitoring intravenous infusion site for infiltration. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: ivWatch, LLC

Dates:
Date Received: November 9, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 17, 2012
Last Verified: November 2011