ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

Not Applicable

Completed

• Conditions: Infiltration of Peripheral IV Therapy
• Interventions: Device: ivWatch Model 400 with SmartTouch and fiber optic sensor

• Registration Number: NCT04065373
• Lead Sponsor: ivWatch, LLC

Brief Summary

A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch and fiber optic sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-25
• Primary Completion: 2019-06-21
• Study Completion: 2019-06-21
• Status Verified: 2019-08
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Study First Posted: 2019-08-22
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Informed consent
• Pass health screen
• 18 years or older

Exclusion Criteria

• Fail health screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-Infiltrated Tissue	ivWatch Model 400 with SmartTouch and fiber optic sensor	The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored a common peripheral IV site over a 24 hour observation period.

Primary Outcome Measures

Name	Time	Method
Normal Tissue Red Notification Rate	24 Hours	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 a negative binomial regression model.

Secondary Outcome Measures

Name	Time	Method
Normal Tissue Yellow Notification Rate	24 Hours	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 a negative binomial regression model.
Significant Skin Irritation or Disruption to Skin Integrity	24 Hours	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.

Trial Locations

Locations (1)

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