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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
43
The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.
ivWatch, LLC
Williamsburg, Virginia, United States
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.
Time frame: 24 hours
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.
Time frame: 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.
Time frame: 24 hours
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