ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

Study Overview
=================
Brief Summary
-----------------
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Official Title
-----------------
ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

Conditions
-----------------
Infiltration of Peripheral IV Therapy

Intervention / Treatment
-----------------
* Device: ivWatch Model 400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Pass health screen 18 years or older Exclusion Criteria: Fail health screen

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Infiltrated Tissue<br>The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. | Device: ivWatch Model 400<br>* The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal Tissue Red Notification Rate | The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using the Clopper-Pearson method. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal Tissue Yellow Notification Rate | The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method. | 24 hours | 
| Significant Skin Irritation or Disruption to Skin Integrity | The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval. | 24 hours | 

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