Lateral Patient Transfer
Conditions
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.
Interventions
DEVICESimPull Lateral Transfer Device
Automated lateral transfer device
OTHERSurvey
Complete Survey
Sponsors
The Patient Company, LLC
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Lateral Transfer | Baseline | The average total time (minutes) it took to complete a lateral transfer. |
| The Number of Staff Involved in a Transfer | Baseline | The average number of staff members engaged during transfers |
| Average Weight of Participants | Baseline | The average weight (kilograms) of participants who underwent a lateral transfer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Satisfaction | Baseline | Number of survey responses where clinicians indicated they were satisfied with the transfer method |
| The Number of Survey Responses From Clinicians Who Indicated They Were Very Likely to Experience Injury During Transfers | Baseline | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Group 2: SimPull Device Transfer | Total | Group 1: Standard of Care Transfer |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 33 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 67 Participants | 33 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 17 Participants | 30 Participants | 13 Participants |
| Sex: Female, Male Male | 33 Participants | 70 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 0 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 0 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 0 |
Outcome results
Primary
Average Weight of Participants
The average weight (kilograms) of participants who underwent a lateral transfer
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Standard of Care Transfer | Average Weight of Participants | 86.24 kilograms | Standard Deviation 20.23 |
| Group 2: SimPull Device Transfer | Average Weight of Participants | 89.47 kilograms | Standard Deviation 22.57 |
Primary
The Number of Staff Involved in a Transfer
The average number of staff members engaged during transfers
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Standard of Care Transfer | The Number of Staff Involved in a Transfer | 4.98 staff members | Standard Deviation 0.87 |
| Group 2: SimPull Device Transfer | The Number of Staff Involved in a Transfer | 4.92 staff members | Standard Deviation 0.88 |
Primary
Time to Complete Lateral Transfer
The average total time (minutes) it took to complete a lateral transfer.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Standard of Care Transfer | Time to Complete Lateral Transfer | 33.40 minutes | Standard Deviation 121.4 |
| Group 2: SimPull Device Transfer | Time to Complete Lateral Transfer | 4.094 minutes | Standard Deviation 1.688 |
Secondary
Clinician Satisfaction
Number of survey responses where clinicians indicated they were satisfied with the transfer method
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Group 1: Standard of Care Transfer | Clinician Satisfaction | Standard of Care-subject moved using the standard of practice lateral patient transfer methods | 44 Survey Responses |
| Group 1: Standard of Care Transfer | Clinician Satisfaction | SimPull Device Transfer-subject moved using the SimPull automated lateral transfer device | 40 Survey Responses |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Group 1: Standard of Care Transfer | The Number of Survey Responses From Clinicians Who Indicated They Were Very Likely to Experience Injury During Transfers | Standard of Care-subject moved using the standard of practice lateral patient transfer methods | 0 Survey Responses |
| Group 1: Standard of Care Transfer | The Number of Survey Responses From Clinicians Who Indicated They Were Very Likely to Experience Injury During Transfers | SimPull Device Transfer-subject moved using the SimPull automated lateral transfer device | 2 Survey Responses |