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

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ClinicalTrials.gov Identifier: NCT03505957
Recruitment Status : Active, not recruiting
First Posted : April 23, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Washington University School of Medicine
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Lineus Medical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
IV Dislodgement Device: SafeBreak Vascular Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: SafeBreak Vascular works with all IVs. The study participants will have SafeBreak Vasculars installed in all of their existing IV lines or new IV lines that are installed during their enrollment in the study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : September 7, 2018
Estimated Study Completion Date : October 7, 2018

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 Name: SafeBreak




Primary Outcome Measures :
  1. IV dislodgement rate [ Time Frame: Up to 7 days ]
    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%.


Secondary Outcome Measures :
  1. IV restarts [ Time Frame: Up to 7 days. ]
    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

  2. Device related adverse events [ Time Frame: Up to 7 days ]
    Collection of any adverse events related to SafeBreak Vascular



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505957


Locations
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United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Lineus Medical
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
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Study Director: Kelly Bochicchio, RN, MS Washington University School of Medicine
Study Director: Stacey Reese, RN, MS Washington University of St. Louis

Publications:
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Responsible Party: Lineus Medical
ClinicalTrials.gov Identifier: NCT03505957     History of Changes
Other Study ID Numbers: v001 03.09.2018
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Lineus Medical:
IV Dislodgement