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OpenTrials
Completed

NCT Number: NCT04469218

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital

Hartford, Connecticut, 06102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SafeBreak Vascular

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.

Other names: Patient safety disconnect

Primary outcomes

  1. Delay in Therapy

    Time frame: 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

    A comparison in delays in therapy between the control group and the intervention group.

Secondary outcomes

  1. Estimate the Impact for Other Peripheral IV Complications.

    Time frame: 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

    A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group.

Sponsors and collaborators

Lead sponsor

Lineus Medical

Industry

Collaborators

  • Hartford HealthCare
  • Hartford Hospital
  • Technomics Research

Registry information

Official study title

Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)

Acronym: DIPPER

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2020
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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