ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
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|ClinicalTrials.gov Identifier: NCT02120443|
Recruitment Status : Completed
First Posted : April 22, 2014
Results First Posted : June 23, 2014
Last Update Posted : July 2, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Infiltration of Peripheral IV Therapy||Device: ivWatch Model 400||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Informed consent
- Pass health screen
- 18 years or older
- Fail health screen
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
|United States, Virginia|
|Williamsburg, Virginia, United States, 23185|
|Responsible Party:||Garret Bonnema, Chief Science Officer, ivWatch, LLC|
|Other Study ID Numbers:||
|First Posted:||April 22, 2014 Key Record Dates|
|Results First Posted:||June 23, 2014|
|Last Update Posted:||July 2, 2014|
|Last Verified:||June 2014|
peripheral intravenous therapy