InfiltrationNCT01800552
Ultrasound Detection of Peripheral IV Infiltration
An observational study of Infiltration and IV Infiltration, run by ivWatch, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine whether commercial ultrasound imaging systems can discern normal from infiltrated tissue near a peripheral intravenous site. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infiltration, IV Infiltration
- What is being tested?
- Intentional infiltration of a peripheral IV site
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers (18 years or older) that were friends, family members, or employees of ivWatch, LLC participated in this study.
Who may be able to join
- 18 years or older
- signed consent
- health form approved by professional practitioner
Who cannot join
- abnormal bleeding or hemophilia
- absence of sensation in arms
- anemia
- cardiopulmonary disorders
- clotting disorders
- dehydration
Show all 20Show fewer
- dizziness or fainting
- hepatitis
- high blood pressure (>160 systolic or > 115 diastolic)
- HIV / AIDS
- immune deficiency disorders
- known history of difficult venous access
- lymphedema
- major surgery or scar tissue which would complicate venous access
- recent radiation or chemotherapy
- received IV therapy in past 30 days
- history of seizures
- history of strokes
- sick or had infection in past 30 days
- high temperature (>99.6F)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether commercial ultrasound imaging systems can discern normal from infiltrated tissue near a peripheral intravenous site.
Read the detailed description
Peripheral intravenous (PIV) therapy is one of the most common invasive procedures performed in US hospitals. A majority of hospital patients require intravenous therapy each year in the United States. Despite widespread use, a number of potential complications can occur during PIV therapy. One of the most common causes of IV complications is IV infiltration or extravasation. Infiltration is the leakage of non-vesicant fluids like saline into the surrounding tissue. Extravasation is the leakage of vesicant fluids, which include cytotoxic drugs, intravenous nutrition, and calcium, potassium, and bicarbonate solutions. If not detected and corrected early, infiltration and extravasation can lead to significant complications such as severe inflammation, compartment syndrome, and skin necrosis.
ivWatch, LLC has developed an investigational device that may detect IV infiltration and extravasation occurrences using a near infrared light sensor. Previous studies have evaluated the performance of the ivWatch device by comparing to a nurse's diagnosis. The nursing standard of care relies on tactile and visual indicators to diagnose an infiltration event. The ivWatch product often signals an infiltration event before these indicators are apparent to clinicians. Consequently, comparisons to the nurse's diagnosis often lead to questionable false positives for the ivWatch device. A better reference is required to evaluate the performance of the ivWatch device.
The purpose of this research study is to evaluate the ability of ultrasound to detect PIV infiltrations. Ultrasound is a depth-resolved imaging technique for evaluating tissue microstructure. Researchers have used ultrasound to examine exogenous fluids injected into cutaneous and subcutaneous tissue. Ultrasound has been used to detect small volumes of fluids such as cosmetic fillers and subcutaneous injections. These studies suggest ultrasound may be a potential reference standard for future evaluation of ivWatch devices.
- Conditions
- Infiltration, IV Infiltration
- Being tested
- Intentional infiltration of a peripheral IV site
- Keywords
- Infiltration, Extravasation, Leaking, PIV Infiltration, IV Infiltration, Ultrasound Detection of Infiltration, Ultrasound Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intentional infiltration of a peripheral IV siteProcedure or surgery
An intentional infiltration of isotonic saline solution is performed by pushing the needle through the vein wall into the subcutaneous tissue. A total volume less than or equal to 5 cc of saline is infiltrated into the tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
Test diagnostic performance of ultrasound imaging for detection of peripheral IV infiltration.
Ultrasound images are acquired before and after the induced infiltration on the test arm. Two additional ultrasound images are acquired from the normal control arm. At the end of the study, the before and after images from the test and control arms are evaluated and classified by clinicians blinded to the state of the tissue. Sensitivity and specificity metrics are used to evaluate the performance of ultrasound imaging for assessing peripheral IV infiltration.
Measured: Within 15 minutes of intentional PIV infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
- Study completionFeb 2013
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
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ivWatch, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Garret T Bonnema, Ph.D., Principal investigator, ivWatch, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800552
- Sponsor's protocol ID
- IVWUS-001
- Status last verified
- Feb 2013
- First submitted
- 22 Feb 2013
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Detection of Peripheral IV Infiltration
- ClinicalTrials.gov ID
- NCT01800552
- Acronym / sponsor ID
- IVWUS-001
- Conditions
- Infiltration, IV Infiltration
- Keywords
- Infiltration, Extravasation, Leaking, PIV Infiltration, IV Infiltration, Ultrasound Detection of Infiltration, Ultrasound Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ivWatch, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Feb 2013 (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 is to determine whether commercial ultrasound imaging systems can discern normal from infiltrated tissue near a peripheral intravenous site.
Detailed description
Peripheral intravenous (PIV) therapy is one of the most common invasive procedures performed in US hospitals. A majority of hospital patients require intravenous therapy each year in the United States. Despite widespread use, a number of potential complications can occur during PIV therapy. One of the most common causes of IV complications is IV infiltration or extravasation. Infiltration is the leakage of non-vesicant fluids like saline into the surrounding tissue. Extravasation is the leakage of vesicant fluids, which include cytotoxic drugs, intravenous nutrition, and calcium, potassium, and bicarbonate solutions. If not detected and corrected early, infiltration and extravasation can lead to significant complications such as severe inflammation, compartment syndrome, and skin necrosis.
ivWatch, LLC has developed an investigational device that may detect IV infiltration and extravasation occurrences using a near infrared light sensor. Previous studies have evaluated the performance of the ivWatch device by comparing to a nurse's diagnosis. The nursing standard of care relies on tactile and visual indicators to diagnose an infiltration event. The ivWatch product often signals an infiltration event before these indicators are apparent to clinicians. Consequently, comparisons to the nurse's diagnosis often lead to questionable false positives for the ivWatch device. A better reference is required to evaluate the performance of the ivWatch device.
The purpose of this research study is to evaluate the ability of ultrasound to detect PIV infiltrations. Ultrasound is a depth-resolved imaging technique for evaluating tissue microstructure. Researchers have used ultrasound to examine exogenous fluids injected into cutaneous and subcutaneous tissue. Ultrasound has been used to detect small volumes of fluids such as cosmetic fillers and subcutaneous injections. These studies suggest ultrasound may be a potential reference standard for future evaluation of ivWatch devices.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers (18 years or older) that were friends, family members, or employees of ivWatch, LLC participated in this study.
Key inclusion criteria (3 listed)
- 18 years or older
- signed consent
- health form approved by professional practitioner
Key exclusion criteria (20 listed)
- abnormal bleeding or hemophilia
- absence of sensation in arms
- anemia
- cardiopulmonary disorders
- clotting disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intentional infiltration of a peripheral IV siteAn intentional infiltration of isotonic saline solution is performed by pushing the needle through the vein wall into the subcutaneous tissue. A total volume less than or equal to 5 cc of saline is infiltrated into the tissue. | Procedure or surgery | – |
Primary outcome
Test diagnostic performance of ultrasound imaging for detection of peripheral IV infiltration.
Time frame: Within 15 minutes of intentional PIV infiltration
Ultrasound images are acquired before and after the induced infiltration on the test arm. Two additional ultrasound images are acquired from the normal control arm. At the end of the study, the before and after images from the test and control arms are evaluated and classified by clinicians blinded to the state of the tissue. Sensitivity and specificity metrics are used to evaluate the performance of ultrasound imaging for assessing peripheral IV infiltration.
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 27 Feb 2013.
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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.
Garret T Bonnema, Ph.D. principal investigator
ivWatch, LLC
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 IV Infiltration, 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 20 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 27 Feb 2013. 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 diagnostic performance of ultrasound imaging for detection of peripheral IV infiltration. (time frame: Within 15 minutes of intentional PIV infiltration). 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 27 Feb 2013.