A Study to Evaluate SimPull for Lateral Patient Transfer

Not Applicable

Completed

• Conditions: Lateral Patient Transfer
• Interventions: Device: SimPull Lateral Transfer Device

• Registration Number: NCT05856123
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Study Start: 2023-11-16
• Status Verified: 2024-04
• Primary Completion: 2024-08-14
• Study Completion: 2024-08-14
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SimPull Device Transfer	SimPull Lateral Transfer Device	After cardiac catheterization lab or electrophysiology lab procedure, the subject will be moved from one bed to another using the SimPull device.

Primary Outcome Measures

Name	Time	Method
Force needed for transfer	Baseline	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).
Time to complete lateral transfer	Baseline	Total time to complete in seconds each lateral transfer

Secondary Outcome Measures

Name	Time	Method
Clinician Satisfaction	Baseline	Number of clinicians satisfied with the transfer method
Clinician perception of injury risk	Baseline	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"

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States