A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population

SafeBreak Vascular is a medical device indicated for fluid flow control during the administration of IV fluids/medication to the patient's vascular system and to aid in the prevention of unintended disruption and dislodgment of IVs. SafeBreak Vascular may be used for any hospitalized patient with gravity tubing or IV pumps, for intermittent infusion or continuous infusion.The primary objective of this study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing.

Study Overview

• Status: Completed
• Conditions: IV Dislodgement
• Intervention / Treatment: Device: SafeBreak Vascular

Detailed Description

Study participants will have a SafeBreak Vascular installed in each of their existing or newly installed IV lines. The clinical literature shows in prospective observational studies that a mean of 9.2% of patients dislodge their peripheral IVs. SafeBreak Vascular is a medical device designed to aid in the prevention of unintended disruption and dislodgement of IVs, such as peripheral IVs, peripherally inserted central lines, central lines, etc. SafeBreak IV will be installed in each IV line between the study participant's catheter and the IV tubing that goes to the IV bag or IV pump. When a harmful force is placed on the IV line, SafeBreak Vascular is designed to separate so that the harmful force is removed from the line and IV dislodgement is prevented. SafeBreak Vascular has a valve in each end of the device. Upon separation, each valves closes, stopping the flow of fluid. The primary objective of the study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing. The number of IV dislodgements and IV restarts will be recorded. The study will also collect data for analysis concerning the following:

• device design characteristics
• certain human factors (patient or operator) associated with the use of the device
• the impact of this device usage on clinician workflow
• any unknown safety concerns
• obtain preliminary data for use in designing a subsequent pivotal study of the device.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Geriatric trauma patients (> or equal to age 55)
• Participants able to provide informed consent or have a legally authorized representative (LAR) provide consent
• The patients must have IV access (existing central venous catheter, peripherally inserted central catheter, or peripheral IV's) or need IV access
• The patients must be at least 55 years of age.

Exclusion Criteria:

• Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
• Age less than or equal to 54
• Patient on comfort care only
• Predicted to have less than 24 hours survival
• Patient enrolled in an investigational drug or device study at the time of enrollment
• Investigator discretion that patient is not suitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SafeBreak Vascular Intervention; Every study participant will have SafeBreak Vasculars installed in each of their IV lines.	Device: SafeBreak Vascular; SafeBreak Vascular will be installed in all the IV lines of consenting participants for up to 7 days.; Other Names: SafeBreak

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IV dislodgement rate	Compare the study intervention's rate of IV dislodgement to the clinical literature's prospective observational studies that have a mean dislodgement of 17.5% and median of 9.2%.	Up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IV restarts	Comparison of the study's intervention to the clinical literature's rates for IV failure, which is 46% of IVs fail before the end of their intended use	Up to 7 days.
Device related adverse events	Collection of any adverse events related to SafeBreak Vascular	Up to 7 days

Collaborators and Investigators

• Sponsor: Lineus Medical
• Collaborators: Washington University School of Medicine; Barnes-Jewish Hospital
• Investigators: Study Director: Kelly Bochicchio, RN, MS, Washington University School of Medicine; Study Director: Stacey Reese, RN, MS, Washington University of St. Louis

Publications and helpful links

General Publications

• Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs. 2015 May-Jun;38(3):189-203. doi: 10.1097/NAN.0000000000000100.
• Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): September 23, 2018
• Study Completion (Actual): September 23, 2018

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: IV Dislodgement
• Other Study ID Numbers: v001 03.09.2018

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.: No