Glenn J Butler, Scott Gorenstein, Edward Golembe, Bok Lee
New Clinical Evaluations Support Research
In 2008, Medicare declined to reimburse for care costs related to hospital acquired pressure (HAPU) ulcers. As a result, a wide range of powered mattress systems were developed and sold as the standard of care at that time for Pressure Ulcer prevention. Our research and clinical trial experience demonstrates that the majority (90%+) of acute and sub-acute patients are sensate, semi-ambulatory and capable of functional normal active hyperemia and by definition, do not require, or benefit from powered mattress systems.
Our clinical evaluations also confirm career nursing experience that the heat, noise and movement of powered mattress systems can promote insomnia and induce significant sleep deprivation that may require medication and can retard rehabilitation and increased Length of Stay. Clearly, powered mattress systems are not clinically required for all patients. However, a meaningful, scientific method of determining relative pressure injury risk and objectively evaluating and designing clinical mattress systems is needed.
The authors developed a real-time, simultaneous pressure mapping / deep tissue blood perfusion – oxygen tension measurement system in order to evaluate patient adaption to interface pressures, mattress pressure induced ischemia and relative Injury / ulcer risk. This new technology is patent pending.
Sixteen (16) commercially available alternating, low air loss and non-powered Mattress systems were evaluated during 200+ manned tests from 2008-2015. These studies simultaneously compared total patient / mattress interfacial pressures and deep tissue oxygen tensions in up to 8 anatomical locations considered at greatest risk for pressure injury and ulcer development. These locations included the occipital, scapula, elbows, trochanter, ischium, and sacrum and the heals. The scapula, ischium, sacrum and heal were eventually determined to be at greatest risk for pressure injury and became the standard test locations. Tests were conducted with subjects in supine, 30°, and 70°positions. Twenty (20) test subjects, 8 Females and 12 Males ranging from 18-65 years of age, including 2 paraplegic patients were studied.
Figure 1 Tests were conducted using non-invasive tissue oxygen measurements at four different anatomical locations on a 6’3′, 240 lb. healthy male subject resting on the OXY-MATTM. Results were taken and averaged on 5 different Alternating Mattresses and 6 different Low Air Mattress designs Reference 5
In two independent clinical trials, a total of 103 inpatients were evaluated on powered mattress systems and then transferred to the newly developed non-powered mattress system.(Reference 5) A 17 patient hospital trial published data demonstrated a $48,000 annual (2013) reduction in powered mattress rentals and without the need for heel boots. The same study also demonstrated a Hospital Acquired Pressure Ulcer (HAPU) incidence reduction from 5.5% at the start of 2013 trial and down to 1.24% by the third quarter. (Figure 2. Reference 6)
Figure 2: Reference 6
Another Nursing and Rehabilitation Center trial of 83 patients (Reference 7) demonstrated the new non-powered mattress system (Figure 1. Reference 4,5) improved sleep, had no new skin breakdowns, existing Stage 3-4 ulcers were stable or improving and existing rash-dermatitis improved to clearing. Four patients had a reduction in pain medication. Two patients preferred to return back to powered beds. This 440-bed institution has recommended the non-powered mattress system as the standard resident mattress and is converting. (Figure 1. Reference 4,5)
As of November 2016, several other major (100+ bed) trials are in progress with similar outcomes resulting in a reduction in powered mattress utilization, rental costs with improved patient satisfaction and clinical outcomes according to independent medical staffs.
Figure 3: Normal Active Hyperemia demonstrated:
This Simultaneous Interface Pressure / Oxygen Graph displays Ischium Pressure / deep tissue Oxygen values only for clarity. Standard Studies include scapula, ischium, sacrum, trochanter, and heels. The subject changed position from a standing to a supine position, elevated to a 70 degree recline and returned to a standing position in 20 minute intervals. In both standing and Supine positions, ischium tissue oxygen averaged 55% while the ischium pressure averaged 26mmHg in the supine position. At the 70 degree position, the subject’s weight transferred to the ischium.
The average interface pressure rose to 99mmHg while the ischium oxygen tension decreased to 51%. The net pressure from the supine to sitting position increased over 280%, but the oxygen only decreased by 6.5%. This is an example of human body auto-regulating blood perfusion (normal active hyperemia) This is a typical example of how pressure and blood perfusion are not inversely proportional in the majority (90%+) of patients that are able to perform clinically meaningful auto regulation/active hyperemia. Such patients do not require powered mattress systems which unnecessarily increase costs, insomnia and can affect length of Stay. Reference 4
- For over 60 years, healthcare mattress systems have been designed solely on patient/mattress interfacial pressure mapping and subjective comfort. Our research and clinical trials support the predominant literature that pressure mapping alone is not a reliable real-time indicator of mattress design superiority.
- The 2008 assumption that placing all patients on elaborate powered mattress systems would mitigate pressure ulcers has demonstrated to be largely incorrect. The over-utilization of powered mattress systems has resulted in multiple millions of dollars in unnecessary healthcare costs for powered mattress equipment and can affect Length of Stay.
- It is estimated that 90%+ of all hospital and long-term care facility patients are capable of clinically functional normal active hyperemia and should only be placed on non-powered equalizing mattress systems to improve restorative sleep and lower cost of care. Only Patients incapable of semi-ambulatory movement and able to induce normal active hyperemia should be placed in powered mattresses systems that induce involuntary movement.
- Tissue interface pressure and blood perfusion are not inversely proportional. Simultaneous pressure/oxygen saturation testing indicates that there is no positive correlation between increased patient/mattress interface pressures and decreased blood perfusion in tissue as measured by blood oxygen saturation oximetry.
- The pathophysiology of pressure ulcer development is just beginning to be understood. The true dynamics of repetitive ischemia/reperfusion injury as they relate to deep-tissue oxygen/nutrient supply and cell metabolite management are critical to pressure injury prevention, ulcer development, and wound care.
- The time and tissue interface pressures required to induce an ischemic / reperfusion injury event vary significantly from patient to patient with age, co-morbidities, and functional circulatory auto-regulation as major factors.
- In extensive laboratory testing and clinical trials, the Oxy- Mat™ was shown to be functionally superior to Group 2 powered mattresses by consistently lowering averaged interface pressures and permitting increased natural deep tissue oxygen values as compared to 16 commercially available powered and non-powered mattress systems.
- Agency for Healthcare Research and Quality, Rockville, MD, January 2015 http://www.ahrq.gov/professionals/systems/long-term-care/resources/pressure-ulcers/index.html
- McInnes E, Dumville JC, Jammali-Blasi A, Bell-Syer SEM. Support surfaces for treating pressure ulcers. Cochrane Database of Systematic Reviews 2011, Issue 12. Art. No.:CD009490. DOI: 10.1002/14651858.CD009490
- Zamboni WA, Stephenson LL, Roth AC, et al. Ischemia-reperfusion injury in skeletal muscle: CD 18-dependant neutrophil-endothelial adhesion and arteriolar vasoconstriction. Plast Reconstr Surg 1997;99(7):2002–7.
- Butler G, Kenyon D, Golembe E, et al. Oxy-Mat Mattress System Development Utilizing Simultaneous Measurement of Interface Pressure and Deep Tissue Oxygen Saturation. Surg Tech Int. 2015; XXVI:71-82
- OXY-MAT ™ CMS / Medicare Homecare #EO373 Advance Pressure Reducing Mattress;USA & Foreign Patents Awarded #9,295,599 & Patent Pending #7,761,945 – US20130281804-A1, Meets Canadian Bed Entrapment Standards
- Donatelli E, Rogers C, Adler, M. New York Presbyterian Hudson Valley Hospital – Cost Savings and Pressure Injury / Ulcer Reduction in a 7-week Clinical Trial of a Non-Powered Pressure Redistribution Mattress System Design. Magnet Hospital Innovation Report 2013, SAWC-Fall 2016 Poster Presentation.
- Quality Assurance / Performance Improvement Report – Effectiveness of OXY-MAT Therapeutic Mattress February 2014, Gurwin Jewish Nursing and Rehabilitation Center.
Glenn J Butler1, Scott Gorenstein2, Edward Golembe3, Bok Lee4
1Life Support Technologies group, 2Winthrop University Hospital, 3Westchester Medical Center, 4 New York Medical College
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580 White Plains Road, Suite 110 Tarrytown NY 10591