ivWatch Sensor: Device Validation for Infiltrated Tissues
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ivWatch, LLC
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Red Notification Sensitivity to Infiltrated Tissues
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Informed Consent
- •Pass health screen by clinician
- •18 years or older
Exclusion Criteria
- •Fail health screen
Arms & Interventions
Infiltrated Tissue
The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
Intervention: ivWatch Model 400 with SmartTouch Sensor (Device)
Infiltrated Tissue
The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
Intervention: ivWatch Model 400 with Fiber Optic Sensor (Device)
Outcomes
Primary Outcomes
Red Notification Sensitivity to Infiltrated Tissues
Time Frame: After each participant has been infiltrated, an expected average of 1 hour
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.
Secondary Outcomes
- Yellow Notification Sensitivity to Infiltrated Tissues(After each participant has been infiltrated, an expected average of 1 hour)
- Infiltrated Volume When Red Notification Issued(After each participant has been infiltrated, an expected average of 1 hour)
- Infiltrated Volume When Yellow Notification Issued(After each participant has been infiltrated, an expected average of 1 hour)
- Significant Skin Irritation or Disruption to Skin Integrity(After each participant has been infiltrated, an expected average of 1 hour)