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

NCT ID: NCT04469218

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-14
• Study Completion Date: 2020-12-31

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.

Conditions

IV Catheter-Related Infection or Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

SafeBreak Vascular Group

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.

Group Type: EXPERIMENTAL

SafeBreak Vascular

Intervention Type: 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.

Interventions

SafeBreak Vascular

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.

Intervention Type: DEVICE

Other Intervention Names

Patient safety disconnect

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hartford HealthCare

OTHER

Sponsor Role: collaborator

Hartford Hospital

OTHER

Sponsor Role: collaborator

Technomics Research

INDUSTRY

Sponsor Role: collaborator

Lineus Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Steere

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P002

Identifier Type: -

Identifier Source: org_study_id