ivWatch Sensor: Device Validation for Infiltrated Tissues

Study Overview
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Brief Summary
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A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.

Official Title
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ivWatch Sensor: Device Validation for Infiltrated Tissues

Conditions
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Infiltration of Peripheral IV Therapy

Intervention / Treatment
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* Device: ivWatch Model 400 with SmartTouch Sensor
* Device: ivWatch Model 400 with Fiber Optic Sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Pass health screen by clinician 18 years or older Exclusion Criteria: Fail health screen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infiltrated Tissue<br>The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr. | Device: ivWatch Model 400 with SmartTouch Sensor<br>* The ivWatch Model 400 with SmartTouch Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.<br>Device: ivWatch Model 400 with Fiber Optic Sensor<br>* The ivWatch Model 400 with Fiber Optic Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red Notification Sensitivity to Infiltrated Tissues | The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution. | After each participant has been infiltrated, an expected average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yellow Notification Sensitivity to Infiltrated Tissues | The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution. | After each participant has been infiltrated, an expected average of 1 hour | 
| Infiltrated Volume When Red Notification Issued | The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device. | After each participant has been infiltrated, an expected average of 1 hour | 
| Infiltrated Volume When Yellow Notification Issued | The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device. | After each participant has been infiltrated, an expected average of 1 hour | 
| Significant Skin Irritation or Disruption to Skin Integrity | The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study. | After each participant has been infiltrated, an expected average of 1 hour |