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Clinical Trials/NCT01476293
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

ivWatch, LLC1 site in 1 country139 target enrollmentAugust 2011

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
February 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

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