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| Name | Class |
|---|---|
| The Patient Company, LLC | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Standard of Care Transfer | No Intervention | 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. | |
| Group 2: SimPull Device Transfer | Experimental | After cardiac catheterization lab or electrophysiology lab procedure, the subject will be moved from one bed to another using the SimPull device. |
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| Group 3: Clinicians | Active Comparator | Study clinicians complete a survey after conducting intervention or standard of care on participants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SimPull Lateral Transfer Device | Device | Automated lateral transfer device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Lateral Transfer | The average total time (minutes) it took to complete a lateral transfer. | Baseline |
| The Number of Staff Involved in a Transfer | The average number of staff members engaged during transfers | Baseline |
| Average Weight of Participants | The average weight (kilograms) of participants who underwent a lateral transfer | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Satisfaction | Number of survey responses where clinicians indicated they were satisfied with the transfer method | Baseline |
| The Number of Survey Responses From Clinicians Who Indicated They Were Very Likely to Experience Injury During Transfers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deanna Covelli, MSN, RN | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Clinical Trials | View source |
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Only Group 1 and Group 2 were actual participants who were enrolled in the study. Data was only collected for Group 1 and Group 2. Group 3 consisted of clinicians (provided the intervention or standard of care to Group 1 and Group 2 participants). Group 3 did not receive any intervention nor were they enrolled in the study. Group 3 only participated in the post intervention/standard of care survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 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. |
| FG001 | Group 2: 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. SimPull Lateral Transfer Device: Automated lateral transfer device |
| FG002 | Group 3: Clinicians | Study clinicians complete a survey after conducting intervention or standard of care on participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Group 3 was not enrolled in the study. They participated in the evaluation of this intervention as providers. This group did not receive the study intervention nor standard of care, and no demographic data was collected from this group. Only data from Group 1 and Group 2 is reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 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. |
| BG001 | Group 2: SimPull Device Transfer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Complete Lateral Transfer | The average total time (minutes) it took to complete a lateral transfer. | Posted | Mean | Standard Deviation | minutes | Baseline |
|
Adverse events were collected from the time of informed consent through study completion, approximately 1 hour.
CTCAE version 5.0. Group 3 did not participate in the intervention or standard of care and were not enrolled in the study. Adverse events were not collected from the clinician participants in Group 3.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deanna Covelli | Mayo Clinic | 480-342-5284 | covelli.deanna@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2024 | Aug 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Survey | Other | Complete Survey |
|
Measured by a post transfer survey where clinicians indicated 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 |
After cardiac catheterization lab or electrophysiology lab procedure, the subject will be moved from one bed to another using the SimPull device. SimPull Lateral Transfer Device: Automated lateral transfer device |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | The Number of Staff Involved in a Transfer | The average number of staff members engaged during transfers | Posted | Mean | Standard Deviation | staff members | Baseline |
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| Primary | Average Weight of Participants | The average weight (kilograms) of participants who underwent a lateral transfer | Posted | Mean | Standard Deviation | kilograms | Baseline |
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| Secondary | Clinician Satisfaction | Number of survey responses where clinicians indicated they were satisfied with the transfer method | A survey was provided to every study clinician who participated in a standard of care lateral transfer or a SimPull lateral transfer. A survey was provided to every study clinician who participated in a standard of care lateral transfer or a SimPull lateral transfer. There were 14 more survey responses in the SimPull group because some of the SimPull transfers required the involvement of more than one of the study clinicians to complete the transfer of the patient. | Posted | Count of Units | Survey Responses | Baseline | Survey Responses | Survey Responses |
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| Secondary | The Number of Survey Responses From Clinicians Who Indicated They Were Very Likely to Experience Injury During Transfers | Measured by a post transfer survey where clinicians indicated 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." | A survey was provided to every study clinician who participated in a standard of care lateral transfer or a SimPull lateral transfer. There were 14 more survey responses in the SimPull group because some of the SimPull transfers required the involvement of more than one of the study clinicians to complete the transfer of the patient. | Posted | Count of Units | Survey Responses | Baseline | Survey Responses | Survey Responses |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Group 2: 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. SimPull Lateral Transfer Device: Automated lateral transfer device | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | Group 3: Clinicians | Group 3 participants were not enrolled to the study and participated only in study evaluation. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| SimPull Device Transfer-subject moved using the SimPull automated lateral transfer device |
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| SimPull Device Transfer-subject moved using the SimPull automated lateral transfer device |
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