CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 148 enrolled
Drug / intervention
SafeBreak Vasculardevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04469218
NCT04469218N/ACompleted

Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)

Lineus Medical·interventional·Posted Jul 13, 2020·Updated Jan 16, 2024

In Brief

A clinical study evaluating SafeBreak Vascular for IV Catheter-Related Infection or Complication. Completed, enrolled 148 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 13, 2020
Enrollment StartJul 14, 2020
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.0 years ago

Interventions

SafeBreak Vasculardevice

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.