Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ivWatch, LLC
ClinicalTrials.gov Identifier:
NCT01476293
First received: November 9, 2011
Last updated: February 17, 2012
Last verified: November 2011
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids

Further study details as provided by ivWatch, LLC:

Primary Outcome Measures:
  • Test performance of optical device for monitoring intravenous infusion site for infiltration. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 139
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from Cincinnati Children's Hospital Medical Center.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476293

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
ivWatch, LLC
Investigators
Principal Investigator: Darcy Doellman, RN Children's Hospital Medical Center, Cincinnati
Principal Investigator: Sylvia Rineair, MSHA, BSN Children's Hospital Medical Center, Cincinnati
Principal Investigator: Neil Johnson, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Michael Spigarelli, MD, PhD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: ivWatch, LLC
ClinicalTrials.gov Identifier: NCT01476293     History of Changes
Other Study ID Numbers: ivWatch-CT-001
Study First Received: November 9, 2011
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by ivWatch, LLC:
Infiltration
Extravasation
Leaking
PIV Infiltration
IV Infiltration
Optical Detection of Infiltration
Optical Monitoring

Additional relevant MeSH terms:
Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014