NCT01476293

Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 139 (actual)
• Sponsor: ivWatch, LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infiltration
• Extravasation
• IV Infiltration
• IV Extravasation
• Extravasation of Diagnostic and Therapeutic Materials

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-11-22
• Last updated: 2012-02-20

Locations

1 site across 1 country: United States