A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications

Not Applicable

Completed

Brief 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 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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
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

Arm && Interventions

Group	Intervention	Description
SafeBreak Vascular Group	SafeBreak Vascular	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.

Primary Outcome Measures

Name	Time	Method
Delay in Therapy	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.

Secondary Outcome Measures

Name	Time	Method
Estimate the Impact for Other Peripheral IV Complications.	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 IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group.