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

Lineus Medical

Status: Completed

Conditions: IV Catheter-Related Infection or Complication

Treatments: Device: SafeBreak Vascular

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04469218

P002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Control Group

No Intervention group

Description:

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

SafeBreak Vascular Group

Experimental group

Description:

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.

Treatment:

Device: SafeBreak Vascular