Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

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.

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Key information

Conditions

Infiltration Extravasation Extravasation of Diagnostic and Therapeutic Materials IV Extravasation IV Infiltration Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

signed consent
patient age under 12
PIV with continuous fluids

Exclusion criteria

no consent
patient age over 12
PIV fluids not continuous

Treatment and study plan

Primary outcomes

Test performance of optical device for monitoring intravenous infusion site for infiltration.

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

ivWatch, LLC

Industry

Registry information

Official study title

Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Nov 22, 2011
Registry last updated: Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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