IV SafeLock Device Functionality in Emergency Department

Overview

The purpose of this research study is to evaluate the functionality of the IV SafeLock in the clinical emergency department setting.

Full Title of Study: “Functionality of the IV SafeLock Device in Emergency Department Setting”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2023

Interventions

  • Device: IV SafeLock
    • Designed to prevent patient access to intravenous lines in the hospital setting. The device locks with an institution specific key and protects the hub as well as all tubing access points.

Arms, Groups and Cohorts

  • Experimental: Emergency Department Nurses
    • Registered nurses will use the IV SafeLock Device on patients during care in the emergency department.

Clinical Trial Outcome Measures

Primary Measures

  • Functionality of the IV SafeLock
    • Time Frame: Baseline
    • Measured on a likert scale for nurse evaluation of IV SafeLock

Participating in This Clinical Trial

Inclusion Criteria

  • Emergency Department nurses who are consenting and willing to perform tasks. – Their patient population will include stable patients 18 or over, who present through triage, are medically stable, are able to verbally consent and require intravenous access. Exclusion Criteria:

  • Emergency Department nurses who are unwilling to consent to use IV SafeLock on their patient population. – The patient population will exclude pregnant patients, children, prisoners, patients with dementia, or any member of protected class as specified by IRB. – The patients must be medically stable and not include patients presenting with acute stroke, acute myocardial infarction, severe sepsis or shock.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kara J. Bragg, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Kara Bragg, APRN, DNP, Principal Investigator, Mayo Clinic

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