Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

Completed

• Conditions: IV Infiltration; Infiltration; Extravasation; IV Extravasation; Extravasation of Diagnostic and Therapeutic Materials

• Registration Number: NCT01476293
• Lead Sponsor: ivWatch, LLC

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 Description

Not available

Study Timeline

• Study Start: 2011-08
• Status Verified: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• signed consent
• patient age under 12
• PIV with continuous fluids

Exclusion Criteria

• no consent
• patient age over 12
• PIV fluids not continuous

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test performance of optical device for monitoring intravenous infusion site for infiltration.	6 months

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States