Optical Detection of Intravenous Infiltration:A Pilot Study

ivWatch, LLC243 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

243

Conditions

Infiltration of Peripheral IV Therapy

Interventions

ivWatch Model 400DEVICE

The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Time Infiltration Detected by Nurse

The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.

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

Infiltration Sensitivity

The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.

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

Notification Rate of ivWatch Device

The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.

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

Data from ClinicalTrials.gov

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