ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

ivWatch, LLC45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Infiltration of Peripheral IV Therapy

Interventions

ivWatch Model 400 with SmartTouch and fiber optic sensorDEVICE

The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored tissue at common IV sites over a 24 hour period.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent * Pass health screen * 18 years or older Exclusion Criteria: * Fail health screen

Locations (1)

ivWatch, LLC

Williamsburg, Virginia, United States

Outcomes

Primary Outcomes

Normal Tissue Red Notification Rate

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.

Time frame: 24 Hours

Secondary Outcomes

Normal Tissue Yellow Notification Rate

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.

Time frame: 24 Hours

Significant Skin Irritation or Disruption to Skin Integrity

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.

Time frame: 24 Hours

Data from ClinicalTrials.gov

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