NCT01476293
Completed
Not Applicable
Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infiltration
- Sponsor
- ivWatch, LLC
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- Test performance of optical device for monitoring intravenous infusion site for infiltration.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •signed consent
- •patient age under 12
- •PIV with continuous fluids
Exclusion Criteria
- •no consent
- •patient age over 12
- •PIV fluids not continuous
Outcomes
Primary Outcomes
Test performance of optical device for monitoring intravenous infusion site for infiltration.
Time Frame: 6 months
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Optical Detection of Intravenous InfiltrationIntravenous InfiltrationExtravasation of Diagnostic and Therapeutic MaterialsNCT01126710CW Optics, Inc.263
Completed
Not Applicable
Optical Detection of Intravenous Infiltration:A Pilot StudyInfiltration of Peripheral IV TherapyNCT02553421ivWatch, LLC243
Completed
Not Applicable
Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous AccessIV CannulationNCT00935909Peter Szmuk603
Completed
Not Applicable
Optical Detection Infiltration/Extravasation in Neonates (ODINE)Extravasation InjuryInfant, Premature, DiseasesNCT05638971Fondazione Policlinico Universitario Agostino Gemelli IRCCS50
Completed
Not Applicable
Tissue Perfusion and Blood Flow Monitoring TechnologyWounds and InjuriesNCT01139567CW Optics, Inc.56