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

Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)

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.

Study Overview

• Status: Completed
• Conditions: IV Catheter-Related Infection or Complication
• Intervention / Treatment: Device: SafeBreak Vascular

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.
Experimental: 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.	Device: 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.; Other Names: Patient safety disconnect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the Impact for Other Peripheral IV Complications.	A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart 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

Collaborators and Investigators

• Sponsor: Lineus Medical
• Collaborators: Hartford Hospital; Hartford HealthCare; Technomics Research
• Investigators: Principal Investigator: Lee Steere, Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: IV Care; IV Complication
• Additional Relevant MeSH Terms: Infections; Catheter-Related Infections
• Other Study ID Numbers: P002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes