NCT05695183

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

January 12, 2023

Last Update Submit

October 6, 2023

Conditions

Intravenous Access

Outcome Measures

Primary Outcomes (1)

  • Functionality of the IV SafeLock

    Measured on a likert scale for nurse evaluation of IV SafeLock

    Baseline

Study Arms (1)

Emergency Department Nurses

EXPERIMENTAL

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

Device: IV SafeLock

Interventions

IV SafeLockDEVICE

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.

Emergency Department Nurses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

  • 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.

    PMID: 38529519DERIVED

Related Links

Study Officials

  • Kara Bragg, APRN, DNP

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

July 22, 2023

Primary Completion

October 6, 2023

Study Completion

October 6, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)