- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01476293
Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation
February 17, 2012 updated by: ivWatch, LLC
Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids
The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events.
Infiltration is an indication that the PIV is leaking fluids outside of the vascular system.
The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
139
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be recruited from Cincinnati Children's Hospital Medical Center.
Description
Inclusion Criteria:
- signed consent
- patient age under 12
- PIV with continuous fluids
Exclusion Criteria:
- no consent
- patient age over 12
- PIV fluids not continuous
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Test performance of optical device for monitoring intravenous infusion site for infiltration.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Darcy Doellman, RN, Children's Hospital Medical Center, Cincinnati
- Principal Investigator: Sylvia Rineair, MSHA, BSN, Children's Hospital Medical Center, Cincinnati
- Principal Investigator: Michael Spigarelli, MD, PhD, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
November 9, 2011
First Submitted That Met QC Criteria
November 17, 2011
First Posted (Estimate)
November 22, 2011
Study Record Updates
Last Update Posted (Estimate)
February 20, 2012
Last Update Submitted That Met QC Criteria
February 17, 2012
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ivWatch-CT-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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