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

NCT04469218 | Completed Results FDA Device

• 1 other identifier: P002
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

IV Catheter-Related Infection or Complication

Keywords

IV Care; IV Complication

Outcome Measures

Primary Outcomes (1)

• Delay in Therapy

  A comparison in delays in therapy between the control group and the intervention group.

  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

Secondary Outcomes (1)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.

SafeBreak Vascular Group

EXPERIMENTAL

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.

Device: SafeBreak Vascular

Interventions

SafeBreak Vascular DEVICE

SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails.

Also known as: Patient safety disconnect

SafeBreak Vascular Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lineus Medical: lead
• Hartford HealthCare: collaborator
• Hartford Hospital: collaborator
• Technomics Research: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Results Point of Contact

• Title: CEO
• Organization: Lineus Medical

vance@lineusmed.com

844-546-3728

Study Officials

• Lee Steere

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The use of devices is randomly assigned to subjects in the study, but it is not possible to blind the patient, the care providers, the investigators or the outcomes assessor as to which group received the study device.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized clinical trial with a control group receiving the standard of care peripheral IV treatment and a second group that utilizes SafeBreak Vascular, a break-away connector, in the peripheral IV.

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: July 14, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)