ivWatch Sensor: Device Validation for Infiltrated Tissues

Not Applicable

Completed

• Conditions: Infiltration of Peripheral IV Therapy
• Interventions: Device: ivWatch Model 400 with SmartTouch Sensor; Device: ivWatch Model 400 with Fiber Optic Sensor

• Registration Number: NCT04064229
• Lead Sponsor: ivWatch, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-03
• Primary Completion: 2019-04-09
• Study Completion: 2019-04-09
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Results First Submitted: 2022-04-19
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-31
• Last Update Submitted: 2022-05-31
• Results First Posted: 2022-06-24
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Informed Consent
• Pass health screen by clinician
• 18 years or older

Exclusion Criteria

• Fail health screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infiltrated Tissue	ivWatch Model 400 with Fiber Optic Sensor	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.
Infiltrated Tissue	ivWatch Model 400 with SmartTouch Sensor	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.

Primary Outcome Measures

Name	Time	Method
Red Notification Sensitivity to Infiltrated Tissues	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 Outcome Measures

Name	Time	Method
Yellow Notification Sensitivity to Infiltrated Tissues	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 yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
Infiltrated Volume When Red Notification Issued	After each participant has been infiltrated, an expected average of 1 hour	The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.
Infiltrated Volume When Yellow Notification Issued	After each participant has been infiltrated, an expected average of 1 hour	The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.
Significant Skin Irritation or Disruption to Skin Integrity	After each participant has been infiltrated, an expected average of 1 hour	The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.

Trial Locations

Locations (1)

ivWatch, LLC; 🇺🇸 Williamsburg, Virginia, United States