IV SafeLock Device Functionality in Emergency Department

NCT ID: NCT05695183

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-22

Study Completion Date

2023-10-06

Brief Summary

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

Detailed Description

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Conditions

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Intravenous Access

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Emergency Department Nurses

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

Group Type EXPERIMENTAL

IV SafeLock

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kara J. Bragg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kara Bragg, APRN, DNP

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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Bragg K, Albus M, Bragg B, Beste RM, Simon LV. Evaluation of the Functionality in an Emergency Department Setting of an Intravenous Protection Device to Prevent Self-Injection. Med Devices (Auckl). 2024 Mar 19;17:135-142. doi: 10.2147/MDER.S451439. eCollection 2024.

Reference Type DERIVED
PMID: 38529519 (View on PubMed)

Related Links

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Other Identifiers

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22-012282

Identifier Type: -

Identifier Source: org_study_id

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