Sarah Roberts, Robert Fields, Casey Shumberger, Alexis Bertram
ABSTRACT
Mobilizing intensive care unit patients has been shown to improve their health outcomes by shortening their healing time and length of hospital stay. However, getting these critically ill patients up and moving can be a challenge. Through our work with ICU staff from the Medical University of South Carolina, we have designed an early mobility walker that provides support to the patient and ease of use for the clinician. Unlike our competitors, we have created a design that provides patient access directly from the bed, collapsibility for easy storage in limited hospital space, and support for a variety of medical equipment commonly found in the ICU.
BACKGROUND
The National Institute of Health describes critical care as “care [that] helps people with life-threatening injuries and illnesses…[which] usually takes place in an intensive care unit (ICU) or trauma center.” In America alone, more than four million patients are admitted to an ICU annually, costing over 80 billion dollars in 2005. (1). The Medical University of South Carolina Medical Center admitted 35,538 patients in 2012, approximately 1,000 of which were placed in the ICU (2). Critical care patients also account for a disproportionately large percentage of mortality. Early ambulation and mobilization programs (EAP) have been proven to reduce patient mortality and morbidity, decrease length of stay (LOS), and improve patient outcomes (3,4,5,6). Early ambulation is a paradigm for combating the pathologies that arise from periods of immobility including ulcers, muscle atrophy, and respiratory compromise.
The medical device industry is addressing the importance of early mobilization in the ICU. Products exist to help in all stages of EAP such as the Phoneris/Aeroflux System from Medline, which protects against disconnections between the patient and the ventilator during ambulation; the Rifton Tram, which is a multi-purpose ambulatory aide; and the LIVENGOOD MPCE, which facilitates movement despite bulky medical equipment. The MPCE is designed to consolidate nearly all of the life-sustaining equipment necessary for a patient under intensive care in a single mobile platform. This consolidation facilitates the late stages of EAP’s such as short distance ambulation, affording hospitalized individuals a higher quality of life, and placing them at a lower risk for secondary complications associated with immobility.
Our clinical stakeholders, Dr. Dee Ford and Dr. Andrew Goodwin, are associated with an early ambulation program at the Medical University of South Carolina (MUSC) as part of a pilot study about the benefits of early mobility in the ICU. Through direct observation and conversations with clinicians in the ICU, we have discovered that one of the main problems with current mobility platforms at MUSC is that the bases of most platforms are too bulky to fit under the hospital beds, which have just a few inches of clearance. This makes it difficult to get the platform very close to the bed, which can make transfers from the bed to standing more challenging and therefore less safe both for the patient and ICU staff involved. Furthermore, storage space is very limited in the ICU; mobility platforms take up too much space when they aren’t in use.
Needs Statement and Criteria
Based on our clinical observations as well as interactions with our clinical stakeholders, we have concluded that there is a need to create a mobilization platform that improves patient accessibility and that takes up less storage space compared to existing platforms. This new mobility platform must meet or exceed current levels of patient accessibility, must meet or exceed patient support and safety provided by current platforms, and must take up less storage space than current platforms. Based on our clinicians’ suggestions, the new mobility platform should include hand supports for the patient, a seat or other mechanism to catch patient if they fall, and holders for vital equipment like IV bags, oxygen tanks, and monitors to maximize the patient’s mobility potential.
Market Need
An assessment of both the clinical and customer needs for ICU patient mobility devices is essential in order to understand the overall market need for our proposed product. ICU early mobility programs have been shown to improve muscle strength, functional mobility, and quality of life while reducing patient mortality and morbidity. Early mobility programs enabled by ICU patient mobility devices can address the clinical need to improve patient outcomes in the ICU. Early ambulation rehabilitation protocols can also result in significant cost savings by reducing hospital and/or ICU length of stay (LOS), hospital readmissions, and duration of mechanical ventilation. The Society of Critical Care Medicine reported on a controlled trial of 330 acute respiratory failure patients who were prescribed either early mobility rehabilitation or usual care strategies. Financial data acquired from this experiment revealed that “the average cost per patient in the mobility group was $41,142 compared with $44,302 in the usual care group” (7). In addition, the researchers conducting this trial found that “the mobility group also had lower absolute costs ($6.8 million vs. $7.3 million)” (7). ICU patient mobility devices that facilitate implementation of early mobility programs can tackle the need to minimize operating costs incurred by healthcare facilities.
METHODS & APPROACH
As an attempt to distinguish our product from competitors, our ICU patient mobility platform includes a few novel design features meant to address the limitations of devices currently on the market. The first unique quality that we have implemented in the design of our product is low-profile ball transfer wheels on the back of the device to allow greater patient accessibility during transitions between the critical care bed and the walker. The walkers currently in use at MUSC feature back wheels that are too tall, and consequently, they cannot fit under the ICU beds.
Another innovation that has been included in the design of our device is an easily disassembled frame to promote easy storage. Currently, there is an array of medical devices that must be able to fit within the narrow confines of the ICU. To avoid contributing to the preexisting clutter of the ICU, walkers and platforms must be designed to be compact and easily stored. We have included a mechanism in our device that allows the front piece to be easily separated from the sides, allowing for completely collapsed storage. In future prototype versions, this feature could also allow for different sized pieces to accommodate patients of various heights and widths.
The final innovation we have included in our design is the ability to support a variety of medical equipment. Critical care patients require a lot of monitoring and support to sustain them, and almost all of this equipment is vital, meaning that it cannot be left at the bed when the patient gets up to move around. In order to accommodate this, our walker includes storage options for important pieces of equipment. Specifically, the device includes a site for a detachable IV pole, hooks to support oxygen tanks and various monitors, and a shelf to hold miscellaneous items. These features reduce the number of staff needed to accompany a patient and free up valuable walkway space.
EVALUATION
Preliminary computer model testing using SolidWorksTM indicates that our device will be structurally sound and able to support the weight of a patient, as well as about 100 pounds of medical equipment.
Additional testing of the physical prototype is set to begin Monday, April 21st and will include evaluations of mobility, supportiveness, and ease of disassembly.
ACKNOWLEDGEMENTS
We would like to thank the Clemson University Department of Bioengineering for their support and guidance. Special thanks to the following people for their direct mentorship and instruction with regards to this project.
Clemson University Department of Bioengineering Mentors
Dr. John DesJardins, Kayode Karunwi, Dr. Hai Yao, Dr. Tong Ye, Angela Alexander, Feng Wei, Wenjun He
Medical University of South Carolina Clinical Partners
Dr. Andrew Goodwin, Dr. Dee Ford, Medical ICU nursing and physical therapy staff
AUTHOR CONTACT INFORMATION
Sarah Roberts
1622 Piedmont Park Rd. Ext.
Greenville, SC 29609
srober5@clemson.edu
REFERENCES
- “Critical Care Statistics.” SCCM. Society of Critical Care Medicine, n.d. Web. 05 Dec. 2013.
- Needham, Dale M., FCA, MD, PhD, and Ann Parker, MD. “The Importance of Early Rehabilitation and Mobility in the ICU.” SCCM. Society of Critical Care Medicine, n.d. Web. 05 Dec. 2013.
- Zomorodi, M., D. Topley, and M. McAnaw, Developing a mobility protocol for early mobilization of patients in a surgical/trauma ICU. Crit Care Res Pract, 2012. 2012: p. 964547.
- Adler, J. and D. Malone, Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J, 2012. 23(1): p. 5-13.
- Fisher, S.R., et al., Early ambulation and length of stay in older adults hospitalized for acute illness. Arch Intern Med, 2010. 170(21): p. 1942-3.
- Creditor, M.C., Hazards of hospitalization of the elderly. Ann Intern Med, 1993. 118(3): p. 219-23.Andolfi, Alexander S. Patient Transfer Walker. Alexander S. Andolfi, assignee. Patent US 5411044 A. 2 May 1995. Print.
- Razon, Eli. Sit Down and Stand Up Walker with Seat Assembly. Eli Razon, assignee. Patent US 20120000496 A1. 5 Jan. 2012. Print.