IV SafeLock Device Functionality in Emergency Department

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05695183

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intravenous Access	Device: IV SafeLock	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Functionality of the IV SafeLock Device in Emergency Department Setting

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Emergency Department Nurses

Registered nurses will use the IV SafeLock Device on patients during care in the emergency department.

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.

Outcome Measures

Primary Outcome Measures

Functionality of the IV SafeLock [Baseline]
Measured on a likert scale for nurse evaluation of IV SafeLock

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Kara Bragg, APRN, DNP, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Kara J. Bragg, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05695183

Other Study ID Numbers:

22-012282

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of Jan 23, 2023