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Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01476293
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Observational
Actual Enrollment : 139 participants
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
Study Start Date : August 2011
Primary Completion Date : February 2012
Study Completion Date : February 2012
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Test performance of optical device for monitoring intravenous infusion site for infiltration. [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ivWatch, LLC
ClinicalTrials.gov Identifier: NCT01476293     History of Changes
Other Study ID Numbers: ivWatch-CT-001
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: November 2011

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