A Study to Evaluate SimPull for Lateral Patient Transfer

Single-site, Pilot Study Evaluating SimPull as a Primary Means of Lateral Patient Transfer

The purpose of this research is to test an investigational device called SimPull to see if it is a more efficient method of transferring a patient from one bed to another compared to that of current methods. The purpose of this research is to gather information on the safety and effectiveness of the SimPull device.

Study Overview

• Status: Recruiting
• Conditions: Lateral Patient Transfer
• Intervention / Treatment: Device: SimPull Lateral Transfer Device

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
      • Contact: Deanna Covelli, MSN; Phone Number: 480-342-1528; Email: covelli.deanna@mayo.edu
      • Contact: Jillian Amoroso, APRN; Phone Number: 480-301-6680; Email: amoroso.jillian@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients requiring lateral transfer for an invasive cardiac procedure to and from gurney to exam table.
• Patients requiring lateral transfer for an invasive cardiac procedure to and from exam table to gurney.
• Patient does not have compound fractures or cervical fractures present.
• Patient does not have skin damage or open wounds to the dorsal cavity.
• Patient or legally authorized representative (LAR) must be able/present to sign consent.

Exclusion Criteria:

• Patients who do not require lateral transfer for an invasive cardiac procedure to and from gurney to exam table.
• Patients who do not require lateral transfer for an invasive cardiac procedure to and from exam table to gurney.
• Patient has compound fractures or cervical fractures present.
• Patient has skin damage or open wounds to the dorsal cavity.
• Patient or legally authorized representative (LAR) are unable/present to sign consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Transfer; After cardiac catheterization lab or electrophysiology lab procedure, the subject will be moved from one bed to another using the current standard of practice lateral patient transfer methods by nursing staff.
Experimental: SimPull Device Transfer; After cardiac catheterization lab or electrophysiology lab procedure, the subject will be moved from one bed to another using the SimPull device.	Device: SimPull Lateral Transfer Device; Automated lateral transfer device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete lateral transfer	Total time to complete in seconds each lateral transfer	Baseline
Force needed for transfer	Calculated by patient weight and the number of clinicians engaged during manual transfers. Example: Patient weight: 265 lbs., five clinicians: 53 lbs. per clinician (51% higher than the 35 lb. OSHA mandate).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Satisfaction	Number of clinicians satisfied with the transfer method	Baseline
Clinician perception of injury risk	Measured by a post transfer survey where clinicians indicate how likely they feel they are to be injured during lateral patient transfer using standard transfer methods versus SimPull on a scale of "Not at all likely", "Not likely", "Neutral", "Likely", or "Very Likely"	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: The Patient Company, LLC
• Investigators: Principal Investigator: Deanna Covelli, MSN, RN, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 22-004929

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: Yes