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ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02120443
Recruitment Status : Completed
First Posted : April 22, 2014
Results First Posted : June 23, 2014
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Garret Bonnema, ivWatch, LLC

Study Description
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Brief Summary:
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Condition or disease Intervention/treatment Phase
Infiltration of Peripheral IV Therapy Device: ivWatch Model 400 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-Infiltrated Tissue
The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
 Device: ivWatch Model 400
The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.


Outcome Measures
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Primary Outcome Measures :
  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 the Clopper-Pearson method.


Secondary Outcome Measures :
  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 the Clopper-Pearson method.

  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Fail health screen
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120443


Locations
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United States, Virginia
ivWatch, LLC
Williamsburg, Virginia, United States, 23185
Sponsors and Collaborators
ivWatch, LLC
More Information
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Responsible Party: Garret Bonnema, Chief Science Officer, ivWatch, LLC
ClinicalTrials.gov Identifier: NCT02120443    
Other Study ID Numbers: IVW400CS-05
First Posted: April 22, 2014    Key Record Dates
Results First Posted: June 23, 2014
Last Update Posted: July 2, 2014
Last Verified: June 2014
Keywords provided by Garret Bonnema, ivWatch, LLC:
infiltration
extravasation
peripheral intravenous therapy