Optical Detection of Intravenous Infiltration:A Pilot Study

Study Overview
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Brief Summary
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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.

Conditions
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Infiltration of Peripheral IV Therapy

Intervention / Treatment
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* Device: ivWatch Model 400


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilot<br>A non-alarming ivWatch device will monitor the IV sites of these subjects. The goal of this small pilot study is to give clinicians an opportunity to perform the protocol and operate the ivWatch device and to give researchers the ability to make adjustments prior to starting the subsequent non-alarming group. | Device: ivWatch Model 400<br>* 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.<br>|
| Experimental: Non-alarming<br>150 patients will be enrolled in the non-alarming group. The ivWatch device will monitor the IV sites but will not issue infiltration notifications. | Device: ivWatch Model 400<br>* 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.<br>|
| Experimental: Alarming<br>150 patients will be enrolled in the alarming group. The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled. | Device: ivWatch Model 400<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infiltration, extravasation, peripheral intravenous therapy