Status:
COMPLETED
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
Lead Sponsor:
Lineus Medical
Collaborating Sponsors:
Hartford HealthCare
Hartford Hospital
Conditions:
IV Catheter-Related Infection or Complication
Eligibility:
All Genders
18+ years
Phase:
NA
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 curren...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04469218
Start Date
July 14 2020
End Date
December 31 2020
Last Update
January 16 2024
Active Locations (1)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06102