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A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Infiltrated Tissue | Experimental | The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivWatch Model 400 | Device | The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Check IV notification rate per day | The ivWatch Model 400 issues Check IV 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 a negative binomial regression model. | 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Naramore CTO, MS | Contact | (855) 489-2824 | jason.naramore@ivwatch.com | |
| Marisa Brown, BS | Contact | (855) 489-2824 | marisa.brown@ivwatch.com |
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