A Study to Evaluate SimPull for Lateral Patient Transfer

Study Overview
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Brief Summary
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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.

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

Conditions
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Lateral Patient Transfer

Intervention / Treatment
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* Device: SimPull Lateral Transfer Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Transfer<br>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<br>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<br>* Automated lateral transfer device<br>|

What is the study measuring?
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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 |