A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population

Completed · Not applicable

Conditions studied: IV Dislodgement

In brief

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.

Key facts

Study ID

NCT03505957

Run by

Lineus Medical

People needed

40

Starts

2018-05-07

Expected to finish

2018-09-23

Last updated by the study team

2020-03-05

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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