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

NCT03505957 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-03-05

No results posted yet for this study

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.

Conditions

  • IV Dislodgement

Interventions

DEVICE

SafeBreak Vascular

SafeBreak Vascular will be installed in all the IV lines of consenting participants for up to 7 days.

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • Barnes-Jewish Hospital

    collaborator OTHER

  • Lineus Medical

    lead INDUSTRY

Principal Investigators

  • Kelly Bochicchio, RN, MS · Washington University School of Medicine

  • Stacey Reese, RN, MS · Washington University of St. Louis

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2018-09-23
Completion
2018-09-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505957 on ClinicalTrials.gov