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Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

NCT01476293 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 139

Last updated 2012-02-20

No results posted yet for this study

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

Sponsors & Collaborators

  • ivWatch, LLC

    lead INDUSTRY

Principal Investigators

  • Darcy Doellman, RN · Children's Hospital Medical Center, Cincinnati

  • Sylvia Rineair, MSHA, BSN · Children's Hospital Medical Center, Cincinnati

  • Neil Johnson, MD · Children's Hospital Medical Center, Cincinnati

  • Michael Spigarelli, MD, PhD · Children's Hospital Medical Center, Cincinnati

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01476293 on ClinicalTrials.gov