A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population
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|ClinicalTrials.gov Identifier: NCT03505957|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2018
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|IV Dislodgement||Device: SafeBreak Vascular||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population|
|Actual Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||September 7, 2018|
|Estimated Study Completion Date :||October 7, 2018|
Experimental: SafeBreak Vascular Intervention
Every study participant will have SafeBreak Vasculars installed in each of their IV lines.
Device: SafeBreak Vascular
SafeBreak Vascular will be installed in all the IV lines of consenting participants for up to 7 days.
Other Name: SafeBreak
- 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%.
- IV restarts [ Time Frame: Up to 7 days. ]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
- Device related adverse events [ Time Frame: Up to 7 days ]Collection of any adverse events related to SafeBreak Vascular
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505957
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Study Director:||Kelly Bochicchio, RN, MS||Washington University School of Medicine|
|Study Director:||Stacey Reese, RN, MS||Washington University of St. Louis|