Optical Detection of Intravenous Infiltration:A Pilot Study

Completed · Not applicable

Conditions studied: Infiltration of Peripheral IV Therapy

In brief

This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.

Key facts

Study ID

NCT02553421

Run by

ivWatch, LLC

People needed

243

Starts

2015-08-01

Expected to finish

2016-07-01

Last updated by the study team

2017-04-06

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed consent and/or assent
• Newborn to 17 years of age
• Weight > 2.5 kg

You may not qualify if…

• Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives
• Severe scarring of tissue (excessive IV use)
• Tattoo in area of PIV site
• IV site located in antecubital fossa

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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