ivWatch Model 400: Device Validation for Infiltrated Tissues

A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.

Study Overview

• Status: Completed
• Conditions: Infiltration of Peripheral IV Therapy
• Intervention / Treatment: Device: The ivWatch Model 400

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Williamsburg, Virginia, United States, 23185
      • ivWatch, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Fail health screen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infiltrated Tissue; The ivWatch Model 400 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.	Device: The ivWatch Model 400; The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red Notification Sensitivity to Infiltrated Tissues	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.	After each participant has been infiltrated, an expected average of 1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ivWatch, LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 28, 2014

Study Record Updates

• Last Update Posted (Estimate): June 27, 2014
• Last Update Submitted That Met QC Criteria: May 27, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: infiltration; extravasation; peripheral intravenous therapy
• Other Study ID Numbers: IVW400CS-06