IV DislodgementNCT03505957
A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population
A study testing SafeBreak Vascular in people with IV Dislodgement, run by Lineus Medical at 1 site in United States.
Trial summary
SafeBreak Vascular is a medical device indicated for fluid flow control during the administration of IV fluids/medication to the patient's vascular system and to aid in the prevention of unintended disruption and dislodgment of IVs. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- IV Dislodgement
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 23 Sep 2018
- Phase
- Interventional
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Geriatric trauma patients (> or equal to age 55)
- Participants able to provide informed consent or have a legally authorized representative (LAR) provide consent
- The patients must have IV access (existing central venous catheter, peripherally inserted central catheter, or peripheral IV's) or need IV access
- The patients must be at least 55 years of age.
Who cannot join
- Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
- Age less than or equal to 54
- Patient on comfort care only
- Predicted to have less than 24 hours survival
- Patient enrolled in an investigational drug or device study at the time of enrollment
- Investigator discretion that patient is not suitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
SafeBreak Vascular is a medical device indicated for fluid flow control during the administration of IV fluids/medication to the patient's vascular system and to aid in the prevention of unintended disruption and dislodgment of IVs. SafeBreak Vascular may be used for any hospitalized patient with gravity tubing or IV pumps, for intermittent infusion or continuous infusion.The primary objective of this study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing.
Read the detailed description
Study participants will have a SafeBreak Vascular installed in each of their existing or newly installed IV lines. The clinical literature shows in prospective observational studies that a mean of 9.2% of patients dislodge their peripheral IVs. SafeBreak Vascular is a medical device designed to aid in the prevention of unintended disruption and dislodgement of IVs, such as peripheral IVs, peripherally inserted central lines, central lines, etc. SafeBreak IV will be installed in each IV line between the study participant's catheter and the IV tubing that goes to the IV bag or IV pump. When a harmful force is placed on the IV line, SafeBreak Vascular is designed to separate so that the harmful force is removed from the line and IV dislodgement is prevented. SafeBreak Vascular has a valve in each end of the device. Upon separation, each valves closes, stopping the flow of fluid. The primary objective of the study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing. The number of IV dislodgements and IV restarts will be recorded. The study will also collect data for analysis concerning the following:
- device design characteristics
- certain human factors (patient or operator) associated with the use of the device
- the impact of this device usage on clinician workflow
- any unknown safety concerns
- obtain preliminary data for use in designing a subsequent pivotal study of the device.
- Conditions
- IV Dislodgement
- Being tested
- SafeBreak Vascular
- Keywords
- IV Dislodgement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeBreak VascularDevice
Also called SafeBreak
SafeBreak Vascular will be installed in all the IV lines of consenting participants for up to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| SafeBreak Vascular Intervention | Experimental | Every study participant will have SafeBreak Vasculars installed in each of their IV lines. Receives: Device: SafeBreak Vascular |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV dislodgement rate
Compare the study intervention's rate of IV dislodgement to the clinical literature's prospective observational studies that have a mean dislodgement of 17.5% and median of 9.2%.
Measured: Up to 7 days
Secondary outcomes (2)
IV restarts
Comparison of the study's intervention to the clinical literature's rates for IV failure, which is 46% of IVs fail before the end of their intended use
Measured: Up to 7 days.
Device related adverse events
Collection of any adverse events related to SafeBreak Vascular
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start7 May 2018
- Primary completion23 Sep 2018
- Study completion23 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IV DislodgementStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SafeBreak Vascular works with all IVs. The study participants will have SafeBreak Vasculars installed in all of their existing IV lines or new IV lines that are installed during their enrollment in the study.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lineus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine, Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Kelly Bochicchio, RN, MS, Study director, Washington University School of MedicineStacey Reese, RN, MS, Study director, Washington University of St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505957
- Sponsor's protocol ID
- v001 03.09.2018
- Status last verified
- Mar 2020
- First submitted
- 13 Apr 2018
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.
PubMed 26557487Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs. 2015 May-Jun;38(3):189-203. doi: 10.1097/NAN.0000000000000100.
PubMed 25871866
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population
- ClinicalTrials.gov ID
- NCT03505957
- Acronym / sponsor ID
- v001 03.09.2018
- Conditions
- IV Dislodgement
- Keywords
- IV Dislodgement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lineus MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine, Barnes-Jewish Hospital
- Study start
- 7 May 2018 (actual)
- Primary completion
- 23 Sep 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 23 Apr 2018 (actual)
- 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.
SafeBreak Vascular is a medical device indicated for fluid flow control during the administration of IV fluids/medication to the patient's vascular system and to aid in the prevention of unintended disruption and dislodgment of IVs. SafeBreak Vascular may be used for any hospitalized patient with gravity tubing or IV pumps, for intermittent infusion or continuous infusion.The primary objective of this study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing.
Detailed description
Study participants will have a SafeBreak Vascular installed in each of their existing or newly installed IV lines. The clinical literature shows in prospective observational studies that a mean of 9.2% of patients dislodge their peripheral IVs. SafeBreak Vascular is a medical device designed to aid in the prevention of unintended disruption and dislodgement of IVs, such as peripheral IVs, peripherally inserted central lines, central lines, etc. SafeBreak IV will be installed in each IV line between the study participant's catheter and the IV tubing that goes to the IV bag or IV pump. When a harmful force is placed on the IV line, SafeBreak Vascular is designed to separate so that the harmful force is removed from the line and IV dislodgement is prevented. SafeBreak Vascular has a valve in each end of the device. Upon separation, each valves closes, stopping the flow of fluid. The primary objective of the study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing. The number of IV dislodgements and IV restarts will be recorded. The study will also collect data for analysis concerning the following:
- device design characteristics
- certain human factors (patient or operator) associated with the use of the device
- the impact of this device usage on clinician workflow
- any unknown safety concerns
- obtain preliminary data for use in designing a subsequent pivotal study of the device.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SafeBreak Vascular works with all IVs. The study participants will have SafeBreak Vasculars installed in all of their existing IV lines or new IV lines that are installed during their enrollment in the study.
| Arm | Type | Receives |
|---|---|---|
| SafeBreak Vascular Intervention | Experimental | Device: SafeBreak VascularEvery study participant will have SafeBreak Vasculars installed in each of their IV lines. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Geriatric trauma patients (> or equal to age 55)
- Participants able to provide informed consent or have a legally authorized representative (LAR) provide consent
- The patients must have IV access (existing central venous catheter, peripherally inserted central catheter, or peripheral IV's) or need IV access
- The patients must be at least 55 years of age.
Key exclusion criteria (6 listed)
- Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
- Age less than or equal to 54
- Patient on comfort care only
- Predicted to have less than 24 hours survival
- Patient enrolled in an investigational drug or device study at the time of enrollment
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: SafeBreakSafeBreak Vascular will be installed in all the IV lines of consenting participants for up to 7 days. | Device | SafeBreak Vascular Intervention |
Primary outcome
IV dislodgement rate
Time frame: Up to 7 days
Compare the study intervention's rate of IV dislodgement to the clinical literature's prospective observational studies that have a mean dislodgement of 17.5% and median of 9.2%.
2 secondary outcomes
IV restarts
Time frame: Up to 7 days.
Device related adverse events
Time frame: Up to 7 days
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 5 Mar 2020.
- Background: PubMed 26557487Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.
- Background: PubMed 25871866Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs. 2015 May-Jun;38(3):189-203. doi: 10.1097/NAN.0000000000000100.
- 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.
Kelly Bochicchio, RN, MS study director
Washington University School of Medicine
Stacey Reese, RN, MS study director
Washington University of St. Louis
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 Dislodgement, 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 4 inclusion and 6 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 5 Mar 2020. 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?
IV dislodgement rate (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505957, which also lists 2 linked publications.
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 5 Mar 2020.