CompletedNot Applicable

Optical Detection of Intravenous Infiltration:A Pilot Study

United States243 participantsStarted 2015-08

Plain-language summary

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.

Who can participate

Age range17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed consent and/or assent * Newborn to 17 years of age * Weight \> 2.5 kg Exclusion Criteria: * 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

What they're measuring

Time Infiltration Detected by Nurse

Timeframe: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week

Infiltration Sensitivity

Timeframe: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week

Notification Rate of ivWatch Device

Timeframe: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week

Trial details

NCT IDNCT02553421

SponsorivWatch, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-07

Results submitted2016-11-04

View on ClinicalTrials.gov More Infiltration of Peripheral IV Therapy trials