A single arm trial consisting of 28 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
28
The ivWatch Model 400 with Milky Way Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
ivWatch
Newport News, 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.
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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