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Completed

NCT Number: NCT04065373

ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

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.

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Key information

Conditions

Infiltration of Peripheral IV Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ivWatch, LLC

Williamsburg, Virginia, 23185, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Fail health screen

Treatment and study plan

ivWatch Model 400 with SmartTouch and fiber optic sensor

Device

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

Primary outcomes

  1. Normal Tissue Red Notification Rate

    Time frame: 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 outcomes

  1. Normal Tissue Yellow Notification Rate

    Time frame: 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.

  2. Significant Skin Irritation or Disruption to Skin Integrity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ivWatch, LLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2019
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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