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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
99
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.
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.
ivWatch, LLC
Williamsburg, Virginia, United States
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.
Time frame: After each participant has been infiltrated, an expected average of 1 hour
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After each participant has been infiltrated, an expected average of 1 hour
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