IV Catheter-Related Infection or ComplicationDIPPERNCT04469218
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
A study testing SafeBreak Vascular in people with IV Catheter-Related Infection or Complication, run by Lineus Medical at 1 site in United States.
Trial summary
A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no SafeBreak Vascular) to determine SafeBreak Vascular's impact on IV clinical care and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IV Catheter-Related Infection or Complication
- What is being tested?
- SafeBreak Vascular
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2020to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted into the participating hospital units
- Patients of any gender may participate
- Participants able to provide informed consent or have a legally authorized representative immediately available to provide informed consent
- Patients must have peripheral IV catheter access or need and are planned to have peripheral IV catheter access placed that is anticipated to last a minimum of 24 hours.
- Patients must be receiving intermittent or continuous infusion or have immediate plans to begin an intermittent or continuous infusion
- The patients must be at least 18 years of age with no upper age limit
Who cannot join
- Unable to obtain informed consent or without an available Legally Authorized Representative or Next of Kin to provide surrogate informed consent
- Age less than or equal to 17
- Patient on comfort care only
- Predicted to have an IV infusion that lasts less than 24 hours
- Patient admitted from the Emergency Department refuses to have new peripheral IV catheter placed by IV team
- Patient has two or more peripheral IV catheters at the same time
Show all 10Show fewer
- Patient enrolled in a subject drug or device study at the time of enrollment
- Investigator discretion that patient is not suitable for the study
- Patient is COVID-19 positive
- Patient is receiving an IV infusion with gravity tubing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)
A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no SafeBreak Vascular) to determine SafeBreak Vascular's impact on IV clinical care and complications.
Read the detailed description
This randomized clinical trial's goal is to determine SafeBreak Vascular's impact, a break-away connector that separates when a harmful force is placed on a peripheral IV line, on IV clinical care and complications.
- Being tested
- SafeBreak Vascular
- Keywords
- IV Care, IV Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeBreak VascularDevice
Also called Patient safety disconnect
SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital. |
| SafeBreak Vascular Group | Experimental | Subjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line. Receives: Device: SafeBreak Vascular |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in Therapy
A comparison in delays in therapy between the control group and the intervention group.
Measured: Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first
Secondary outcomes (1)
Estimate the Impact for Other Peripheral IV Complications.
A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group.
Measured: Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start14 Jul 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 IV Catheter-Related Infection or ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical trial with a control group receiving the standard of care peripheral IV treatment and a second group that utilizes SafeBreak Vascular, a break-away connector, in the peripheral IV.
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lineus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hartford HealthCare, Hartford Hospital, Technomics Research
- Responsible party
- Sponsor
- Investigators
- Lee Steere, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469218
- Sponsor's protocol ID
- P002
- Acronym
- DIPPER
- Status last verified
- Dec 2023
- First submitted
- 8 Jul 2020
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)
- ClinicalTrials.gov ID
- NCT04469218
- Acronym / sponsor ID
- DIPPER / P002
- Keywords
- IV Care, IV Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Lineus MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Hartford HealthCare, Hartford Hospital, Technomics Research
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no SafeBreak Vascular) to determine SafeBreak Vascular's impact on IV clinical care and complications.
Detailed description
This randomized clinical trial's goal is to determine SafeBreak Vascular's impact, a break-away connector that separates when a harmful force is placed on a peripheral IV line, on IV clinical care and complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized clinical trial with a control group receiving the standard of care peripheral IV treatment and a second group that utilizes SafeBreak Vascular, a break-away connector, in the peripheral IV.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital. |
| SafeBreak Vascular Group | Experimental | Device: SafeBreak VascularSubjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients admitted into the participating hospital units
- Patients of any gender may participate
- Participants able to provide informed consent or have a legally authorized representative immediately available to provide informed consent
- Patients must have peripheral IV catheter access or need and are planned to have peripheral IV catheter access placed that is anticipated to last a minimum of 24 hours.
- Patients must be receiving intermittent or continuous infusion or have immediate plans to begin an intermittent or continuous infusion
Key exclusion criteria (10 listed)
- Unable to obtain informed consent or without an available Legally Authorized Representative or Next of Kin to provide surrogate informed consent
- Age less than or equal to 17
- Patient on comfort care only
- Predicted to have an IV infusion that lasts less than 24 hours
- Patient admitted from the Emergency Department refuses to have new peripheral IV catheter placed by IV team
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 |
|---|---|---|
| SafeBreak VascularAlso: Patient safety disconnectSafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails. | Device | SafeBreak Vascular Group |
Primary outcome
Delay in Therapy
Time frame: Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first
A comparison in delays in therapy between the control group and the intervention group.
1 secondary outcome
Estimate the Impact for Other Peripheral IV Complications.
Time frame: Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Lee Steere principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeBreak Vascular in people with IV Catheter-Related Infection or Complication, run by Lineus Medical 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 6 inclusion and 10 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 16 Jan 2024. 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 16 Jan 2024). 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?
Delay in Therapy (time frame: Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first). 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 16 Jan 2024.