Clinical Proof-Sources

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1 October,2001 Prepared by: Clinical Proof-Sources Contents: Tempur-Med Mattress Efficacy in Pressure Management Tempur-Medical, Inc Jaggie Fox Way Lexington, KY (800) Office (859) Fax A comparison of select support surfaces using classic and...1 contemporary measurements of performance Investigating the efficacy of a non-powered pressure reducing therapeutic...2 mattress. A retrospective review of non-related independent studies. A preliminary report of using the Tempur-Med Mattress at HealthSouth...2 Rehabilitation Hospital of Colorado Springs Follow-up report on the conversion to Tempur-Med Mattress at HealthSouth...3 Rehabilitation Hospital of Colorado Springs: Assessing continued attainment of current and ongoing goals nine months after the conversion. A randomised clinical trial using different turning intervals as...4 prevention of pressure ulcers Tempur-Med Efficacy in Multi-system Syndromes The Effects of a Tempur-Pedic Mattress on Reducing Insomnia...5 in Patients with Fibromyalgia: An Exploratory Study Tempur-Med Efficacy in Pain/Sleep Management A polysomnographic study of sleep quality with the TempurPedic mattress...5 Presentation, APSS 8 th Annual Convention, Tempur-Med OR Table Pad Efficacy Preliminary Report Evaluation of Tempur-Med OR Table Pad...6 Research into the effect of pressure during surgical operations...7 and the development of pressure sores Tempur-Med Wheelchair Cushion Efficacy Comparative Pressure Reduction...7 Intermediate-term outcomes at an inpatient rehabilitation facility...7 Tempur-Med Mattress Efficacy in Pressure Management A comparison of select support surfaces using classic and contemporary measurements of performance (Smith G, Fontaine R: VAMC, Phoenix, AZ. Internal document scheduled for publication) Abstract: A study was undertaken to investigate two issues related to various types of mattresses typically used in the care of patients. The first element was to evaluate comparative performance and the second element to investigate comparative cost efficiency. Twenty-one (21) individuals (19 outpatients, 1 inpatient, 1 healthy volunteer), were enrolled as a subject population. This population contained significant elements of risk for pressure ulcer development (33% post Spinal Cord Injury (n=7), 38% Braden scores <18 (n=8), 19% Above Knee Amputation (n=3). Each of the subjects were placed on each of six (6) essentially dissimilar types of support surfaces marketed for pressure reduction. Interface pressure readings were obtained using pressuremapping and site-specific techniques. Performance differences were observed between 14 (p<.02) of 15 (p=.08) pairs of mattresses suggesting that some mattress types may have greater efficacy than others. Within these pairs, no evidence was observed supporting any conclusion that as a group, powered support surfaces were always more efficacious than non-powered support surfaces.

2 - 2 - Factors were identified that impact performance over time, even within the same mattress type. Rationale for adjusting objective data to reflect these variances are offered for consideration. Further investigation into this phenomena is recommended. The second element was a mathematical analysis of effective unit cost was based on a proposed combination of performance ranking, acquisition cost, and warranted life. Recommendations for comparing products based on effective unit cost and therapeutic value are offered. While no firm conclusions can be made, this may serve as a model for tools enhancing administrative decision making while balancing clinical needs and financial constraints. Investigating the efficacy of a non-powered pressure reducing therapeutic mattress. A retrospective review of non-related independent studies. (Fontaine, R: Ostomy/Wound Management 2000; 46(9):34-43) Abstract: In an effort to establish the ability of combined data to support conclusions of lateral support surface efficacy, the data from independent studies (N=6) investigating the efficiency and efficacy of a non-powered therapeutic mattress (Tempur-Med, Tempur- Medical, Inc., Lexington, KY) were combined. This combined sample of 75 subjects was generally elderly (70.2 years), with multiple co-morbities, an average Braden score of 12.66, and 8.4% of which had a history of preexisting pressure ulcers (PU) each of which contributed to the risk of developing pressure ulcers. Average albumin of 3.56 and negligible weight loss is indicative of healing potential. 17 subjects without wounds and believed at risk (Braden avg , 29% history of previous ulcers) were treated prophylactically. No wound development was reported over an average of days of mattress use. 45 wounds (32 subjects) were sufficiently documented for wound healing rate analysis. No impact was associated with combining the data across setting. A slight impact was anticipated when combining the data by setting and wound stage. The wounds on 28 of the 32 subjects healed or were reduced in size, three (3) remained unchanged, and one (1) worsened. Overall, wound size reduced by an average of 68.85% over days on the mattress, or 25.5% per week (N=45, p=.0004). Stage I PU reduced 46% per week (N=6, p=.022), stage II ulcers at 33% per week (N= 22, p=.05), stage III ulcers at 6.97% per week (N=13, p=.004) and stage IV at 3.24% per week (N=4, p=.058). A preliminary report of using the Tempur-Med Mattress at HealthSouth Rehabilitation Hospital of Colorado Springs Introduction: With the goal of reducing and more accurately budgeting for the costs associated with pressure management device utilization, while at the same time making efforts to improve services to the patient population in general, it was decided to convert the mattresses on all of the beds from traditional foam replacement mattresses to Tempur- Med therapeutic mattresses. This conversion was implemented December 1, The purpose of this preliminary report is to present early, primarily anecdotal findings of whether or not the conversion was successful. Conclusions The limited data obtained in this simple exercise support no sustainable conclusions. It is worth noting, however, that:

3 - 3 - During the measurement period only a single support surface rental was required healing rates, as observed by medical and nursing staff, were satisfactory incidence rates were reduced from already low levels ( 3% to 0.5%) through out the life of the conversion mattresses, savings of $107,000 or 55% of predicted cost is projected even if ongoing rental support surfaces are required. Given the short duration covered by this preliminary report, the projected rental utilization may have been heavily skewed by a single rental. Patients and nursing staff were generally accepting of the conversion mattress and specifically expressed preference over the old mattresses. Follow-up report on the conversion to Tempur-Med Mattress at HealthSouth Rehabilitation Hospital of Colorado Springs: Assessing continued attainment of current and ongoing goals nine months after the conversion. Background: In order to track continued performance, chart reviews were made for all individuals having a diagnosis of (pressure ulcers) treated from March through August, Photographic evidence was available for all patients and wounds. Subjective opinion of the photos indicated reduction in the size and severity of wounds on seven out of the eight patients. The wounds on the remaining patient were largely unchanged in size, much as they had been during previous admissions. Data regarding changes in wound size was not available for all cases, however where available, the average was roughly 7% per week. This is not different from the initial measurement period. Wound incidence rates prior to the conversion were reported in the range of 3%. The rates reported during this period were in the range of 0.5-2%, a net improvement. Findings: Wound incidence declined during the evaluated period. The Medical Director indicated that some patients had developed soft spots on their heels, which required attention. Support surface rentals during the period evaluated were limited primarily to fullthickness (certain Stage III and Stage IV pressure ulcers). It was determined that the primary reason for the rentals were not pressure reduction, but air-flow and reduced shear. During the evaluated period, one patient with a history of readmission requiring treatment on a rented powered therapy bed was treated using the Tempur-Med mattress. No differences were noted in wound progress. An initial investment of $32,400 is on target to produce $113,368 in cost reductions during the warranted life of the purchase. This represents a 3.5-fold return on the investment. It was estimated that upgrading to the Tempur-Plus 3 mattress would address the reasons equipment is rented, improving savings to $142,900 (upgrade costs included) or nearly a 4-fold return on their enhanced investment.

4 - 4 - A randomised clinical trial using different turning intervals as prevention of pressure ulcers (Defloor T, University of Gent (Belgum); Grypdonck M, University of Utrecht (Netherlands); Haalboom J, University Hospital of Utrecht (Netherlands)) Objective: To evaluate the effect of different turning intervals and the use of a pressure-reducing mattress on the development of pressure ulcers in geriatric high-risk patients. Methods: Design- Randomized controlled trial Subjects- 831 geriatric nursing home residents (Norton <12 / Braden <17). Intervention- Four (4) experimental groups Group A: turning every 2 hours on standard hospital mattress (n=65) Group B: turning every 3 hours on standard hospital mattress (n=65) Group C: turning every 4 hours on Tempur-Pedic/Med mattress (n=67) Group D: turning every 6 hours on Tempur-Pedic/Med mattress (n=65) All experiment groups: Lying: alternating lateral 30 semi-fowler positioning Sitting: reclined back, legs elevated, air-filled cushion Control group (n=576): Standard preventative care Length of observation: 28 days Results: Incidence of Stage I ulcer (non-blanchable erythema) Group A 38.1% Group B 37.9% Group C 36.5% Group D 36.5% Control 34.8% These differences are not significant (p=0.69) Incidence of Pressure Ulcer Lesion (Stage II/III/IV) Group A 14.3% Group B 24.1% Group C 3.0% Group D 15.9% Control 20.0% These differences are statistically significant (p=0.005) Conclusions: The frequency of routine turning had no impact on the development of Stage I pressure ulcers. It is worth noting that 4-6 hours between turning on the Tempur-Pedic/Med mattress was as effective as the more frequent 2-3 hour turning on the standard hospital mattress. This may indicate the ability of the Tempur-Pedic/Med mattress to endure a 50% margin of error in turning frequency without adverse tissue impact. The frequency of turning had a significant impact on the development of pressure ulcer lesions (stage II/III/IV). Turning every 4 hours on the Tempur-Pedic/Med mattress was more effective than the more traditional 2-3 hours on a standard mattress. This factor may be significant in reducing pressure ulcer development risks associated with staffing shortages, available staff responding to the emergency needs of other residents negatively impacting on routine turning schedules, resident non-compliance with turning, or residents where the potential for turning is compromised secondary to physical or functional limitations.

5 - 5 - Tempur-Med Efficacy in multi-system syndromes The Effects of a Tempur-Pedic Mattress on Reducing Insomnia in Patients with Fibromyalgia: An Exploratory Study (Young, M) Introduction: Fibromyalgia is a chronic disorder syndrome characterized by musculoskeletal pain, fatigue, and multiple tender points (tenderness that occurs in precise, localized areas, particularly in the neck, spine, shoulders, and hips). People with fibromyalgia frequently experience anxiety, irritable bowel syndrome, sleep disturbances awakening with stiffness, and other symptoms. Fibromyalgia affects 3 to 6 million Americans (American College of Rheumatology). It is most often observed in women of childbearing age, however men, children, and the elderly are not immune. The management of fibromyalgia requires physicians, physical therapists, and the patient each to take an active role in treatment. A comprehensive holistic treatment regime which includes a combination of exercise, medication, and physical therapy has been shown the most effective approach. Aerobic exercise, such as swimming and walking, has been shown to improve muscle conditioning while reducing pain and tenderness. Antidepressant medications may be useful in elevating mood, helping relax muscles, and improving sleep quality. Heat and massage are also useful in obtaining short-term relief. Insomnia is a frequent complaint of individuals with the syndrome. They report difficulty in falling asleep and when they do, sleep is often disturbed because of chronic pain. It is theorized that if this pain could be reduced, without the side-effects of heavy medication, these individuals could see improvement in sleep quality that might improve daily functioning. To this end, it was determined to evaluate a mattress shown to be effective in reducing the pain and discomfort associated with cancer and it s treatment. Conclusion This pilot study cannot support claims of efficacy for any purpose. However, clear trends can be observed in both the quantitative and qualitative analyses. The averages indicate improvements in sleep quality, hours of sleep, and reduction in pain levels experienced while sleeping. The preponderance of comments offered by the subjects were indicative of enhanced quality of life. Based on the findings, a recommendation can be offered in support of the need to conduct a comprehensive study investigating the issues associated with the impact of the Tempur-Pedic mattress on insomnia and quality of life in patients with Fibromyalgia. Tempur-Med Efficacy in Pain/Sleep Management A polysomnographic study of sleep quality with the TempurPedic mattress (Greenberg, H) Subjective Data: Patient reports of mattress comfort with the TempurPedic mattress was 8.9±0.9 vs. 7.7±1.9 for the standard mattress p< Summary of Major Findings: Randomized controlled trial of sleep quality with the TempurPedic mattress compared to a standard mattress:

6 Subjects rated the TempurPedic mattress as more comfortable than the standard mattress. 2. Mattress type (favoring the TempurPedic mattress) was a major factor contributing to the rating of comfort. 3. While objective polysomnographic measures of sleep were not different between mattresses, normal subjects with relatively good sleep quality were studied. Thus, there was little room for improvement in these subjects. 4. Subjects comments overwhelmingly indicated that the TempurPedic mattress was the most comfortable mattress. Presentation, APSS 8 th Annual Convention, 1994 Introduction: This study examines spontaneous movements in children sleeping on an experimental sleep surface, the TempurPedic mattress (Tempur-Pedic, Inc., Lexington, KY). The Tempur-Pedic mattress has textural properties that mold to the sleeper s body and enhance subjective comfort... Implications: Motility during sleep exhibited ultradian rhythmicity in the range of REM sleep cycling, and was evident on both Experimental and Control nights (Exp. Mean min.; Control mean = min.). Interestingly, the Experimental nights yielded significantly shorter motility periods, which may reflect a tendency to cycle more quickly through REM sleep. The movement bout data are consistent with this hypothesis: duration and maximum activity span were significantly shorter in the Experimental condition, but there were more bouts per hour. Further, subjects may be conserving total amount of activity during the sleep period in the experimental condition by expressing shorter, but more frequent, motility bouts. Tempur-Med OR Table Pad Efficacy Preliminary Report Evaluation of Tempur-Med OR Table Pad Abstract: 207 OR procedures, lasting between 2 to 10 hours, were performed. Major diagnoses were: Cardiac 22,7%; Uterine 16.4%; 25 other procedures ranged from.5% to 2.4%. The patients mean age was 58 years, mean weight 175 lbs., mean modified Braden Scale score was 6.8, and mean procedure length was 239 minutes. 75.8% of the procedures were performed in the supine position, 14% in the lothotic position,6.3% in the prone position, and 3.9 in the side lying position. 30 instances of redness were noted following the 207 procedures. Of these, 30, 28 of the reddened areas disappeared (due to reactive hyperemia) 30 minutes following the operation. 2 patients developed stage 1 pressure ulcer sores which were treated postop.

7 - 7 - Research into the effect of pressure during surgical operations and the development of pressure sores (Germain, D: Univ of Wales, School of Nursing studies and Hogeschool van Utrecht (Netherlands)) Abstract: Pressure sores are a serious health problem. Patients with pressure sores run an increased risk of medical complications or an increased risk of death (NPUAP 1998). The incidence of pressure sores varies between 3.5% and 29% (Allman, et at 1986, Breslow 1993, Versuysen 1986). The sample group used for this study consisted of 30 adult patients with an average age of 65.2 years (R=29-82, SD 12.31), height of 1.69m/66.5 (R=1.55m/ m/73.6, SD 7.94),and weight of 71.1 kg/156.7# (R=45kg/99.2#-110kg/242.5#, SD = 14.35) resulting in a Body Mass Index of 24.4 (R=17-41, SD 5.2). who were hospitalized and undergoing surgery at the University Hospital of Leuven. Prior to surgical procedures, pressure mapping was performed using sacral reading for comparison with a standard OR table pad, a gel overlay (Action Gelpad) and the Tempur OR table pad. The interface pressures observed on the Tempur pad (3.75 kpa/28.1 mmhg) were significantly lower than either the standard pad (4.54 kpa/34.05 mmhg) or the Gelpad (4.53kPa/33.97 mmhg) (p=0.002 for each). Differences between the standard pad and the Gelpad were insignificant (p=0.966). The differences in interface pressure observed when comparing Tempur pad with the Gelpad / standard pad during surgical procedures remained significant when adjusted for height (p= / p=0.0018), weight (p= / p=0.0024), Body Mass Index (p= / p=0.0022), gender (p= / p=0.0022) age (p= / p=0.0018), and procedure duration (p= / p=0.0049). None of the patients in the sample group went on to develop pressure sores by post-op days 2 or 4. Tempur-Med Wheelchair Cushion Efficacy Do Pressure Relief Cushions Really Relieve Pressure? (Defloor T. Grypdonck M West J Nurs Res 2000; Apr; 22(2):335-50) In a laboratory setting, interface pressures of 29 cushions and a sheepskin were measured on 20 healthy volunteers. Each participant was seated in an upright position with their backs against the back of the chair, hands resting on the lap, knees bent at an angle of 90 degrees, and feet resting on the floor. Only 13 cushions had any pressure-reducing effect. The category of foam includes both cushions that reduce interface pressure very well and cushions that increase interface pressure. The lowest interface pressures were measured on air cushions and on some foam cushions. Comparative Pressure Reduction Mid-Atlantic Rehabilitation Center conducted pressure mapping studies comparing the 3 TempurMed wheelchair cushion, a visco-elastic static cushion with the Roho Nexus wheelchair cushion, a hybrid foam / adjustable air cell cushion. The mapping indicated similar pressure reduction without the requirement of manual pressure adjustment suggesting greater reliability.

8 - 8 - Intermediate-term outcomes at an inpatient rehabilitation facility. An independent case study monitored the clinical and financial outcomes of 8 patients, treated using the Tempur-Medical Wheelchair cushion presenting with 3 stage I and 9 open stage II pressure ulcers. The length of time wounds were treated ranged from days (mean 64 days). Each of the wounds healed over a period of time ranging from 8-37 days (mean 37 days). Other than pressure management (wheelchair cushion and in some cases a Tempur-Med mattress) all patients received similar care both prior to and after the application of the pressure management intervention. Although no direct evidence connecting the cost of labor with the use of any therapeutic, the researcher noted labor time to treat the wounds. The average daily direct wages consumed in treating these pressure ulcers was $30.92 per day (@29.95/hr). The inference being made is the use of wheelchair pressure management to reduce or eliminate avoidable pressure ulcers has the potential to free up at least an additional hour per day of nursing time which may be used to better benefit in other patient care activities.