Infiltration of Peripheral IV TherapyNCT02553421
Optical Detection of Intravenous Infiltration:A Pilot Study
A study testing ivWatch Model 400 in people with Infiltration of Peripheral IV Therapy, run by ivWatch, LLC at 1 site in United States.
Trial summary
This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Infiltration of Peripheral IV Therapy
- What is being tested?
- ivWatch Model 400
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed consent and/or assent
- Newborn to 17 years of age
- Weight > 2.5 kg
Who cannot join
- Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives
- Severe scarring of tissue (excessive IV use)
- Tattoo in area of PIV site
- IV site located in antecubital fossa
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.
- Conditions
- Infiltration of Peripheral IV Therapy
- Being tested
- ivWatch Model 400
- Keywords
- infiltration, extravasation, peripheral intravenous therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivWatch Model 400Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Experimental | 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. Receives: Device: ivWatch Model 400 |
| Non-alarming | Experimental | 150 patients will be enrolled in the non-alarming group. The ivWatch device will monitor the IV sites but will not issue infiltration notifications. Receives: Device: ivWatch Model 400 |
| Alarming | Experimental | 150 patients will be enrolled in the alarming group. The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled. Receives: Device: ivWatch Model 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Infiltration Detected by Nurse
The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.
Measured: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
Infiltration Sensitivity
The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.
Measured: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
Notification Rate of ivWatch Device
The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.
Measured: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infiltration of Peripheral IV TherapyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- ivWatch, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553421
- Sponsor's protocol ID
- IVW-CLR-CS09-400
- Status last verified
- Mar 2017
- First submitted
- 16 Sep 2015
- Last updated
- 6 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Detection of Intravenous Infiltration:A Pilot Study
- ClinicalTrials.gov ID
- NCT02553421
- Acronym / sponsor ID
- IVW-CLR-CS09-400
- Conditions
- Infiltration of Peripheral IV Therapy
- Keywords
- infiltration, extravasation, peripheral intravenous therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- ivWatch, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Posted 5 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilot | Experimental | Device: ivWatch Model 400A 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. |
| Non-alarming | Experimental | Device: ivWatch Model 400150 patients will be enrolled in the non-alarming group. The ivWatch device will monitor the IV sites but will not issue infiltration notifications. |
| Alarming | Experimental | Device: ivWatch Model 400150 patients will be enrolled in the alarming group. The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Signed consent and/or assent
- Newborn to 17 years of age
- Weight > 2.5 kg
Key exclusion criteria (4 listed)
- Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives
- Severe scarring of tissue (excessive IV use)
- Tattoo in area of PIV site
- IV site located in antecubital fossa
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 |
|---|---|---|
| ivWatch Model 400The 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. | Device | Alarming, Non-alarming, Pilot |
Primary outcome
Time Infiltration Detected by Nurse
Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.
Infiltration Sensitivity
Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.
Notification Rate of ivWatch Device
Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ivWatch Model 400 in people with Infiltration of Peripheral IV Therapy, 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 4 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 6 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Infiltration Detected by Nurse (time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week). The study lists 3 primary outcomes in all. 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 6 Apr 2017.