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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| Barnes-Jewish Hospital | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SafeBreak Vascular Intervention | Experimental | Every study participant will have SafeBreak Vasculars installed in each of their IV lines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SafeBreak Vascular | Device | SafeBreak Vascular will be installed in all the IV lines of consenting participants for up to 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 7 days. |
| Device related adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Bochicchio, RN, MS | Washington University School of Medicine | Study Director |
| Stacey Reese, RN, MS | Washington University of St. Louis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26557487 | Background | 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. | |
| 25871866 | Background | Helm 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. |
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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.
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Collection of any adverse events related to SafeBreak Vascular
| Up to 7 days |