Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285786
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-10-13
Brief Title:
Patient Handling Techniques and New Technology for Health Care Workers
Sponsor:
University of New Brunswick
Organization:
University of New Brunswick
Study Overview
Official Title:
Does Proper Patient Handling Technique Coupled With New Technology Help Reduce Musculoskeletal Demands of Health Care Workers
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patient handling is a major risk-factor for the development of musculoskeletal injuries in healthcare providers To have a significant impact on injury reduction related to patient handling will require the incorporation of technology This project is to investigate a piece of technology that has been designed to facilitate in-bed patient handling The Vendlet
The purpose of this research project is to assess the ability of the Vendlet system outfitted on a Span-America Medical Systems SAMS bed to reduce the physical load on healthcare providers performing patient handling tasks This evidence-based outcomes will be used to support the mitigation of the Vendlet from the European market into the Canadian market The SAMS bed is currently available in North America and has several adjustable features to support patient transfer activities
The project will provide a biomechanical comparison of commonly used patient handling techniques performed using a SAMS bed outfitted with and without a Vendlet patient transfer device This Vendlet technology has the potential to significantly reduce the musculoskeletal and joint strain of healthcare providers while handling patients
The purpose of this research project is to assess the ability of the Vendlet system outfitted on a Span-America Medical Systems SAMS bed to reduce the physical load on healthcare providers performing patient handling tasks This evidence-based outcomes will be used to support the mitigation of the Vendlet from the European market into the Canadian market The SAMS bed is currently available in North America and has several adjustable features to support patient transfer activities
The project will provide a biomechanical comparison of commonly used patient handling techniques performed using a SAMS bed outfitted with and without a Vendlet patient transfer device This Vendlet technology has the potential to significantly reduce the musculoskeletal and joint strain of healthcare providers while handling patients
Detailed Description:
The General Objectives of this project are as followed
1 The first research objective is to build complex movement waveform models to help assess kinematic neuromuscular and force demands related to patient handling and the associated human movement patterns These waveform models will then be used to best answer our two main research questions
2 The second research objective is to build a biomechanical shoulder and back model to determine the cumulative load joint stresses demands related to patient handling as a means to quantify the risk of injury at these highly vulnerable joints These cumulative loading models will then be used to best answer our two main research questions
3 The third and last research objective is to determine the margin of error of a markerless motion capture system compared to a gold standard marker-based motion capture system to determine the feasibility for future research to be conducted in a health care setting and thus increasing the ecological validity of the assessment during a typical working day
This project has the following Research Questions
1 What are the movement technique patterns and physical demands associated with performing patient handling techniques with and without the use of medical bed assistive technology
2 What effect does training have on patient handling techniques Specifically does training help improve the healthcare workers movement patterns as well as reduce physical load demands
This project has the following Research hypotheses
1 It is hypothesized that the use of technology Vendlet system coupled with the SAMS bed will reduce the physical demands of healthcare providers while handling patients
2 Training safe patient handling techniques will result in safer patient handling practices and reduce physical demands while handling patients due to improved movement techniques
Introduction
This project will provide a biomechanical comparison of commonly used patient handling techniques performed using a Span-America Medical Systems SAMS long-term care bed outfitted with and without a Vendlet patient turning system The Vendlet is a powered patient turning aid that replaces the bed-rail system of the hospital bed Using a set of rollers that can be adjusted for height the Vendlet mechanically moves the bed sheet beneath the patient in a controlled manner The system can assist in turning the patient as well as repositioning them in the bed The SAMS long-term care bed is highly adjustable has been designed to facilitate patient handling and was designed around patient safety The researchers will investigate both technologies the Vendlet and SAMS long-term care bed and quantify the reduction physical demands of patient handling when combined
Methods
30 nursing students will be recruited from a regional university and college programs Diversity in participant recruitment will be based on the enrolment proportion in the regional postsecondary programs Each participant will be required to attend two different sessions
1 During the first session participants will receive full instructions on how to use the SAMS Advantage Ready Wide bed and the Vendlet system and will be provided with time to familiarize themselves with the technology Participants will perform 4 different patient repositioning techniques associated with turning the patient 1- reposition the patient vertically to the head of the bed 2- repositioning horizontally in bed from one side to the other side of the bed 3- turning a patient from their back to their side away from the caregiver 4- placing the patient in a sling Each of the techniques will be performed with the two medical bed configurations a the SAMS Advantage Ready Wide hospital bed on its own and b with the Vendlet system mounted on the SAMS bed The order of the repositioning techniques will be randomized and each patient repositioning technique will be performed 3 times
Once the first session is completed each participant will receive the intervention proper training on patient handling care as well as proper training on technology use while handling a patient by a healthcare ergonomist M Léger and an occupational therapist P Beck
2 During the second session participants will return to the laboratory to perform the same 4 different patient repositioning techniques using both bed configurations while applying their new training techniques
Throughout all experimental sessions the following equipment will be used 1- Motion capture system to track individual motions and patient handling performances and develop a biomechanical model to assess joint stress 2- Surface electromyography EMG to monitor neuromuscular activity and effort 3- galvanic skin response system and a heart rate monitor to assess levels of stress 4- Pressure Mats bed and foot mats will be used to measure pressure distributionload demands of handling a patient Participants feedback will also be recorded using exit surveys
Statistical Analysis
A factorial repeated measure mixed analysis of variance ANOVA with a within factors independent variables techniques and two between factor beds and training will be performed to evaluate differences between movement patterns neuromuscular activity perceived discomfort heart rate electrodermal activity foot pressure distribution and bed pressure distribution dependent variables Prior to running the factorial repeated measures ANOVA Skewness and Kutosis will be assessed for normal distribution with a z-score set at 329 The Mulchys test will be used to assess the sphericity assumption When the sphericity assumption is violated the Greenhouse Geiser will be used as a correction The Alpha level will be set at p 05 and if any significant interactions are found the Tukey correction will be used as a post hoc analysis Principal Component Analysis will be incorporated to determine the modes of variation in both the kinematic and kinetic shoulder and joint loads biomechanical motion patterns waveforms while performing the patient handling techniques with and without the incorporated technology
1 The first research objective is to build complex movement waveform models to help assess kinematic neuromuscular and force demands related to patient handling and the associated human movement patterns These waveform models will then be used to best answer our two main research questions
2 The second research objective is to build a biomechanical shoulder and back model to determine the cumulative load joint stresses demands related to patient handling as a means to quantify the risk of injury at these highly vulnerable joints These cumulative loading models will then be used to best answer our two main research questions
3 The third and last research objective is to determine the margin of error of a markerless motion capture system compared to a gold standard marker-based motion capture system to determine the feasibility for future research to be conducted in a health care setting and thus increasing the ecological validity of the assessment during a typical working day
This project has the following Research Questions
1 What are the movement technique patterns and physical demands associated with performing patient handling techniques with and without the use of medical bed assistive technology
2 What effect does training have on patient handling techniques Specifically does training help improve the healthcare workers movement patterns as well as reduce physical load demands
This project has the following Research hypotheses
1 It is hypothesized that the use of technology Vendlet system coupled with the SAMS bed will reduce the physical demands of healthcare providers while handling patients
2 Training safe patient handling techniques will result in safer patient handling practices and reduce physical demands while handling patients due to improved movement techniques
Introduction
This project will provide a biomechanical comparison of commonly used patient handling techniques performed using a Span-America Medical Systems SAMS long-term care bed outfitted with and without a Vendlet patient turning system The Vendlet is a powered patient turning aid that replaces the bed-rail system of the hospital bed Using a set of rollers that can be adjusted for height the Vendlet mechanically moves the bed sheet beneath the patient in a controlled manner The system can assist in turning the patient as well as repositioning them in the bed The SAMS long-term care bed is highly adjustable has been designed to facilitate patient handling and was designed around patient safety The researchers will investigate both technologies the Vendlet and SAMS long-term care bed and quantify the reduction physical demands of patient handling when combined
Methods
30 nursing students will be recruited from a regional university and college programs Diversity in participant recruitment will be based on the enrolment proportion in the regional postsecondary programs Each participant will be required to attend two different sessions
1 During the first session participants will receive full instructions on how to use the SAMS Advantage Ready Wide bed and the Vendlet system and will be provided with time to familiarize themselves with the technology Participants will perform 4 different patient repositioning techniques associated with turning the patient 1- reposition the patient vertically to the head of the bed 2- repositioning horizontally in bed from one side to the other side of the bed 3- turning a patient from their back to their side away from the caregiver 4- placing the patient in a sling Each of the techniques will be performed with the two medical bed configurations a the SAMS Advantage Ready Wide hospital bed on its own and b with the Vendlet system mounted on the SAMS bed The order of the repositioning techniques will be randomized and each patient repositioning technique will be performed 3 times
Once the first session is completed each participant will receive the intervention proper training on patient handling care as well as proper training on technology use while handling a patient by a healthcare ergonomist M Léger and an occupational therapist P Beck
2 During the second session participants will return to the laboratory to perform the same 4 different patient repositioning techniques using both bed configurations while applying their new training techniques
Throughout all experimental sessions the following equipment will be used 1- Motion capture system to track individual motions and patient handling performances and develop a biomechanical model to assess joint stress 2- Surface electromyography EMG to monitor neuromuscular activity and effort 3- galvanic skin response system and a heart rate monitor to assess levels of stress 4- Pressure Mats bed and foot mats will be used to measure pressure distributionload demands of handling a patient Participants feedback will also be recorded using exit surveys
Statistical Analysis
A factorial repeated measure mixed analysis of variance ANOVA with a within factors independent variables techniques and two between factor beds and training will be performed to evaluate differences between movement patterns neuromuscular activity perceived discomfort heart rate electrodermal activity foot pressure distribution and bed pressure distribution dependent variables Prior to running the factorial repeated measures ANOVA Skewness and Kutosis will be assessed for normal distribution with a z-score set at 329 The Mulchys test will be used to assess the sphericity assumption When the sphericity assumption is violated the Greenhouse Geiser will be used as a correction The Alpha level will be set at p 05 and if any significant interactions are found the Tukey correction will be used as a post hoc analysis Principal Component Analysis will be incorporated to determine the modes of variation in both the kinematic and kinetic shoulder and joint loads biomechanical motion patterns waveforms while performing the patient handling techniques with and without the incorporated technology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None