Optical Detection of Intravenous Infiltration:A Pilot Study
NCT ID: NCT02553421
Last Updated: 2017-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
243 participants
INTERVENTIONAL
2015-08-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Pilot
A non-alarming ivWatch device will monitor the IV sites of these subjects. The goal of this small pilot study is to give clinicians an opportunity to perform the protocol and operate the ivWatch device and to give researchers the ability to make adjustments prior to starting the subsequent non-alarming group.
ivWatch Model 400
The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Non-alarming
150 patients will be enrolled in the non-alarming group. The ivWatch device will monitor the IV sites but will not issue infiltration notifications.
ivWatch Model 400
The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Alarming
150 patients will be enrolled in the alarming group. The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.
ivWatch Model 400
The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Interventions
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ivWatch Model 400
The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
Eligibility Criteria
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Inclusion Criteria
* Newborn to 17 years of age
* Weight \> 2.5 kg
Exclusion Criteria
* Severe scarring of tissue (excessive IV use)
* Tattoo in area of PIV site
* IV site located in antecubital fossa
17 Years
ALL
No
Sponsors
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ivWatch, LLC
INDUSTRY
Responsible Party
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Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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IVW-CLR-CS09-400
Identifier Type: -
Identifier Source: org_study_id
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