- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695183
IV SafeLock Device Functionality in Emergency Department
October 6, 2023 updated by: Kara J. Bragg, Mayo Clinic
Functionality of the IV SafeLock Device in Emergency Department Setting
The purpose of this research study is to evaluate the functionality of the IV SafeLock in the clinical emergency department setting.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Emergency Department Nurses
Registered nurses will use the IV SafeLock Device on patients during care in the emergency department.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functionality of the IV SafeLock
Time Frame: Baseline
|
Measured on a likert scale for nurse evaluation of IV SafeLock
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kara Bragg, APRN, DNP, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2023
Primary Completion (Actual)
October 6, 2023
Study Completion (Actual)
October 6, 2023
Study Registration Dates
First Submitted
January 12, 2023
First Submitted That Met QC Criteria
January 12, 2023
First Posted (Actual)
January 23, 2023
Study Record Updates
Last Update Posted (Estimated)
October 9, 2023
Last Update Submitted That Met QC Criteria
October 6, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-012282
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
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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