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

IV Catheter-Related Infection or Complication Clinical Trial

— DIPPER  

Official title:

Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469218
• Other study ID #: P002
• Status: Completed
• Phase: N/A
• Start date: July 14, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2023
• Source: Lineus Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Catheter-Related Infections
• IV Catheter-Related Infection or Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
Lineus Medical	Hartford HealthCare, Hartford Hospital, Technomics Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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