InfiltrationNCT01476293
Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation
An observational study of Infiltration and Extravasation, run by ivWatch, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Infiltration, Extravasation, IV Infiltration
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Subjects will be recruited from Cincinnati Children's Hospital Medical Center.
Who may be able to join
- signed consent
- patient age under 12
- PIV with continuous fluids
Who cannot join
- no consent
- patient age over 12
- PIV fluids not continuous
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
- Conditions
- Infiltration, Extravasation, IV Infiltration, IV Extravasation, Extravasation of Diagnostic and Therapeutic Materials
- Keywords
- Infiltration, Extravasation, Leaking, PIV Infiltration, IV Infiltration, Optical Detection of Infiltration, Optical Monitoring
- Medical subject headings
- Extravasation of Diagnostic and Therapeutic Materials
What is being measured
The primary outcome is the main question the study is designed to answer.
Test performance of optical device for monitoring intravenous infusion site for infiltration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfiltrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- ivWatch, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darcy Doellman, RN, Principal investigator, Children's Hospital Medical Center, CincinnatiSylvia Rineair, MSHA, BSN, Principal investigator, Children's Hospital Medical Center, CincinnatiNeil Johnson, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiMichael Spigarelli, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476293
- Sponsor's protocol ID
- ivWatch-CT-001
- Status last verified
- Nov 2011
- First submitted
- 9 Nov 2011
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids
- ClinicalTrials.gov ID
- NCT01476293
- Acronym / sponsor ID
- ivWatch-CT-001
- Conditions
- Infiltration, Extravasation, IV Infiltration, IV Extravasation, Extravasation of Diagnostic and Therapeutic Materials
- Keywords
- Infiltration, Extravasation, Leaking, PIV Infiltration, IV Infiltration, Optical Detection of Infiltration, Optical Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- ivWatch, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects will be recruited from Cincinnati Children's Hospital Medical Center.
Key inclusion criteria (3 listed)
- signed consent
- patient age under 12
- PIV with continuous fluids
Key exclusion criteria (3 listed)
- no consent
- patient age over 12
- PIV fluids not continuous
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test performance of optical device for monitoring intravenous infusion site for infiltration.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darcy Doellman, RN principal investigator
Children's Hospital Medical Center, Cincinnati
Sylvia Rineair, MSHA, BSN principal investigator
Children's Hospital Medical Center, Cincinnati
Neil Johnson, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infiltration and Extravasation, run by ivWatch, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test performance of optical device for monitoring intravenous infusion site for infiltration. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2012.