Back to resultsIV SafeLock Device Functionality in Emergency Department
Primary Purpose
Intravenous Access
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IV SafeLock
Sponsored by
About this trial
This is an interventional device feasibility trial for Intravenous Access
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Emergency Department Nurses
Arm Description
Registered nurses will use the IV SafeLock Device on patients during care in the emergency department.
Outcomes
Primary Outcome Measures
Functionality of the IV SafeLock
Measured on a likert scale for nurse evaluation of IV SafeLock
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05695183
Brief Title
IV SafeLock Device Functionality in Emergency Department
Official Title
Functionality of the IV SafeLock Device in Emergency Department Setting
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 2023 (Actual)
Primary Completion Date
October 6, 2023 (Actual)
Study Completion Date
October 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to evaluate the functionality of the IV SafeLock in the clinical emergency department setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravenous Access
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emergency Department Nurses
Arm Type
Experimental
Arm Description
Registered nurses will use the IV SafeLock Device on patients during care in the emergency department.
Intervention Type
Device
Intervention Name(s)
IV SafeLock
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functionality of the IV SafeLock
Description
Measured on a likert scale for nurse evaluation of IV SafeLock
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara Bragg, APRN, DNP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
IV SafeLock Device Functionality in Emergency Department
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