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Pressure Relieving Devices

Table of Contents 1. Introduction
2. Literature Review
  2.1. Groups at risk
  2.2. Need for pressure relieving devices
3. Management and cleaning of products
4. Understanding as a product and Evidence of different types
 4.1. Pressure Relieving devices
 4.1.1. Low Tech devices
 4.1.2. High Tech Devices
 4.2. Cost Effectiveness
 4.3. Management of product
  4.3.1. Conformity
  4.3.2. Stability
  4.3.3. Bottoming Out
  4.3.4. Shear Forces
  4.3.5. Heat Absorbing capability
  4.3.6. Capability of Moisture Absorption
  4.3.7. Retardancy to Fire
  4.3.8. Waterproofing
  4.3.9. Cleaning
  4.3.10. Maintenance
  4.3.11. Weight
  4.3.12. Cost
  4.3.13. Types of materials used in mattresses, cushions and overlays
5. Assessment of the use of the products
  5.1. Planning
  5.2. Intervention
  5.3. Evaluation
  5.4. Evidence of uses of products
6. Type of Research and Searches used
  6.1. Bibliographic Source
  6.2. Database Search
  6.3. Methods Used to Collect Evidence
  6.4. Methods Used to Analyze the Evidence
  6.5. Procedure of collecting evidences
  6.6. Type of Research
7. Conclusion
References

1. Introduction

Pressure ulcers also known as bed sores or pressure sores, decubitis ulcers or skin ulcers are the skin problems which affect the bony regions of the body such as the back or cartilaginous region. Patients who are bedridden for long time in Comatose state, paralysed or handicapped and unable to move on their own are vulnerable to pressure ulcers. The main cause for these pressure ulcers is the pressure on a particular body part, which occurs due to a person lying down in the same position for hours together causing prolonged pressure on a particular body part. Blood supply to such body parts is cut off due to continuous pressure, resulting in damage to skin and cell death (Brienza, Karg,Geyer,et al.,2001).

Bed sores, thus are areas of localised damage to skin and underlying tissue and are believed to be caused by friction, pressure and shear continuous to a particular part of the body. They occur prominently over bony areas are common among the very sick and immobile people. They also occur among the patients having epidural analgesia or anaesthesia ,among maternity patients who are disabled through existing conditions like spina bifida, and also among neonates who are

paediatric patients undergoing care in neo-natal intensive care unit(Defloor &Grypdonck,2000).

2. Literature Review

Depending on the degree of damage to tissue, pressure ulcers can be classified into various categories. One such classification according to (Department of Health, 1993)is

Stage1: In this stage, an erythema of the intact skin is identified as pressure ulcer. Even after the pressure is relieved, the reddened part stays red. Important features of the stage include persistent discolouration of the skin. This includes blue-black discolouration on dark skins and non- bleachable erythema on light skins(Brienza, Karg,Geyer,et al.,2001;Department of Health,1993).

Stage2: In this stage, pressure ulcer is defined as partial skin loss involving epidermis or dermis The ulcer is treated clinically as blister, abrasion or a swollen crater and is superficial(Brienza, Karg,Geyer,et al.,2001;Department of Health,1993).

Stage 3: Pressure ulcer involves full thickness skin loss with damage to subcutaneous tissue which may extend to underlying tendon, bone, fascia or joint capsule(Brienza, Karg,Geyer,et al.,2001;Department of Health,1993).

Stage 4: In this stage, a full thickness loss with extensive destruction is presented by the pressure ulcer, damage to muscle, joint capsule or bone tendon or tissue necrosis (Brienza, Karg,Geyer,et al.,2001;Deaprtment of Health,1993).

2.1. Groups at risk

People at particularly high risk of having a pressure ulcer are those with the following risk factors (Brienza, Karg,Geyer,et al.,2001).

Reduced immobility or mobility
Impairment to the sense organs.
Serious illness
Extremity of age
Previous history of pressure ulcer or damage
Vascular disease
Severe or chronic illness, and
Malnutrition.

Some extrinsic factors like friction, pressure, shearing, moisture to the skin and medication also may be responsible for pressure ulcers (Brienza, Karg,Geyer,et al.,2001).

2.2. Need for pressure relieving devices

The above discussion reveals that pressure ulcer is a compounding disease in the sense it attacks an already suffering patient. Instead of trying to treat it, it is better to take preventive measures. It is in this context that pressure relieving devices become relevant (Eccles&Mason,2001).
3. Management and cleaning of products

It is necessary to seek advice from a health care professional or disable living centre regarding the suitability of the pressure-relieving device. Various pressure- relieving devices have various problems cropping as they are used more and more (McGowan,Montgomery,Jolley,et al.,2000). They require proper maintenance and management. Some of these problems are discussed below.

4. Understanding as a product and Evidence of different types

4.1. Pressure Relieving devices

There are two ways of preventing the occurrence of pressure ulcers with the usage of pressure relieving devices.
Low-tech devices involving use of a conforming supporting surface facilitating distribution of the body weight over a large area so that concentration of pressure over a particular part is avoided (Brienza, Karg,Geyer,et al.,2001).
High-tech devices involving use of an alternating support surface where cells which are inflated, inflate and deflate alternatively (Cullum et al . 2001).

According to definition set out by Royal College of Nursing (RCN) guidelines(Rycroft-Malone and Mclnnes 2001) all types of beds and mattresses, overlays, cushions are included in pressure relieving devices with other devices facilitating pressure distribution (Cullum et al.2001). These include beds, mattresses and overlays included in operation theatres.

Mattresses, beds and overlays differ from one another in many ways and can be classified in various ways. The materials they are made from as well as the mechanisms used for pressure-relieving form the basis for such classification (McIntosh, Hutchinson, Home, et.al.2001). For example, CLP (constant low pressure) devices distribute their weight in a large area by moulding around the patient while AP(alternating pressure) devices change their pressure mechanically beneath the patients so that the time duration of the application of pressure is reduced. (Cullum et al.2001).

Classification of pressure redistributing or pressure-relieving is based on HTA,a health technology assessment report (Cullum et al. 2001) since it was accepted to be the most practical. The classification is as under.

4.1.1. Low Tech devices
Standard foam mattresses.
Alternative foam overlays/ mattresses. For example, cubed foam, convoluted foam, viscoelastic and high specification foam. These facilitate redistribution of pressure over larger contact area and are conformable (Medical Devices Agency,2002).
Gel-filled overlays and mattresses.
Fluid-filled overlays/mattresses.
Fluid-filled overlays/mattresses.
Air-filled overlays/mattresses.

4.1.2. High Tech Devices

• Alternating pressure devices are used when the patient lies on the air-filled sacs, which sequentially inflate and deflate and relieve pressure at different anatomical parts for short durations. These may be provided with pressure sensors also (Medical Devices Agency, 2002).
Air-fluidised devices in which warm air is circulated through fine ceramic beads covered by a permeable sheet. They allow support over a large contact area(Medical Devices Agency,2002).
Low air-loss devices where patients are supported on sacs which are filled with air and inflated at a constant pressure. The air can pass through these sacs(Medical Devices Agency,1999).
Turning frames/bed- kinetic or profiling beds where they are either repositioned by motor-driven titling and turning and also aid manual repositioning of the patient (Medical Devices Agency, 2002).

4.2. Cost Effectiveness

Compared to alternating pressure overlays, alternating pressure mattresses have greater benefits and associated with lower costs. They prevent ulceration in patients admitted to hospital. The purchase cost of mattress is high initially and has no significant effect as per statistics on the length of stay of patients in hospital, the proportion of patients who develop an ulcer, severity of ulcers and the time to ulceration. But despite the high initial cost, the purchase cost of these pressure relieving surfaces/devices is less taking their life span into consideration. The difference in the costs between mattresses and overlays is less over this time period. The average cost per day for a two year life span would be AU$2.22 for an overlay and AU$9.17 for a mattress. This difference in cost is less in the context of daily costs of inpatient treatment of around AU$265-AU$618 (depending on specialty) and also the decreased length of stay (on an average,it is around 1.22 of a day less) for recipients with mattresses in this trial. This translates into a reduction of costs of around AU$455.54 per patient. The longer a patient avoids ulceration, less are the chances for the patient to develop a pressure ulcer. This delay in ulceration which is associated with alternating pressure mattresses is important and crucial and allows the patient to recover sufficiently from the acute episode and their risk of ulceration recedes (Miles, 2002).

4.3. Management of product

It is necessary to seek advice from a health care professional or disabled living centre regarding the suitability of the pressure-relieving device. Various pressure relieving devices have various

problems cropping up as they are used more and more(Monaghan,2000). They require proper maintenance and management. Some of the problems are discussed below.

4.3.1. Conformity

Pressure relieving devices made of air, gel, water and memory foam move conforming to the movement of the body as well as its shape. The ability to relieve pressure is decreased for the devices as their surfaces move along with the user by leaning to a side (National Collaborating Centre for Nursing and Supportive Care, 2003).

4.3.2. Stability

Cushions conforming quickly to the body and move in tandem with it might not look safe for a user having difficulty in maintaining sitting balance. This makes transfer from on and off the surface even more difficult. The cushion surface will be pushed down by the user to gain leverage while seating and when the user gets up from the cushion, the weight on the cushion is lifted, the contents will move immediately and the support will disappear(National Collaborating Centre for Nursing and Supportive Care, 2003).

4.3.3. Bottoming Out

A mattress or cushion which is very thin or soft can get compressed allowing the skin and surface to get in contact with each other and the pressure relieving capabilities are removed. This is termed as bottoming out. To prevent this mattresses and cushions should be turned(National Collaborating Centre for Nursing and Supportive Care, 2003).

4.3.4. Shear Forces

Some cushions and mattresses have the capability to reduce shear forces to a considerable extent. Foam mattresses and cushions with cross cut surfaces have the capability to move with the body reducing the pull on the outer skin layer. Apart from these, cushions and mattresses with egg-shaped or individual balloon surfaces have this capability. Cushions which are sloping backwards or which are ramped can reduce the shear as the user has less likelihood of sliding forward (National Collaborating Centre for Nursing and Supportive Care, 2003).

4.3.5. Heat Absorbing capability

The risk of developing sores increases with the increase in heat. Users who get sweaty and hot very often prefer to use cushions to keep their skin cool. Usage of gel and water can keep the skin cool and conduct heat away from the seated area. For some people, this arrangement might be too cold which can slow the metabolism of the cells. This can make their cells absorb oxygen slowly(NICE,2001b).

Bead-filled cushions and mattresses as well as standard foam cushions and mattresses are to be avoided by people who have the tendency of getting hot as these devices do not let air circulate and retain heat. On the other hand, these types of mattresses or cushions are suitable for people who get cold and the cushion or mattress can act as insulation (Sackett,Straus, Richardson et al.,2000).

4.3.6. Capability of Moisture Absorption

The amount of heat produced when a user sits on a mattress or cushion influences the amount of moisture produced. The material with which a cushion cover or mattress is made of, influences moisture absorption. Cotton covers as well as covers made of towelling have absorbing capability. Materials with good vapour permeability allow water vapour and air to circulate. These materials reduce sweating. An example for such a material is platilon. At the same time, these materials are resistant to water, which makes the cushions to stay dry even if fluids are

spilt over it in greater amounts. High level of water vapour is held by natural sheepskins as well which have the capability to reduce sweating as well. Materials like vinyl and nylon do not allow air to circulate and are not absorbent. They can cause sweating excessively (Sackett,Straus, Richardson et al.,2000).

4.3.7. Retardancy to Fire

Various medical devices agencies test the criteria for pressure relief mattresses and cushions. Standards are set for fire retardancy which is very important for users who cannot get themselves out of bed or wheelchair in an emergency and/or those users who smoke(Sackett,Straus, Richardson et al.,2000).

4.3.8. Waterproofing

For users with continence problem, it is suggested to use mattress or cushion with adequate water-proofing. A material made of platilon is suggested for mattress or cushion as it is both water permeable and proofed against water. This allows moist air to circulate through it(Waddell,Feder &,McIntosh. et al. ,1996).

4.3.9. Cleaning

The mattress or cushion as well as its cover should be checked if they can be easily washed or disinfected. A platilon cover can be easily wiped and cleaned. This avoids the need to launder the contents of the cushion or mattress.

4.3.10. Maintenance

The correct amount of pressure relief can be provided through the adjustment of cushions and mattresses. Any person other than the user can make these adjustments with dexterity. Cushions and mattresses with power packs could go wrong and some might need a minor mending after a split or a puncture. It is advisable to have these checks done for a wheelchair cushion. In the case of absence of person who can help, a cushion which does not require maintenance and setting this way is preferred(Medical Devices Agency,2002).

4.3.11. Weight

For users who frequently need to lift a cushion in and out of car or wheel chair, portability of a cushion is important. It is difficult to lift cushions with materials like water or gel though they have handles on the cushion (Medical Devices Agency, 2002).

4.3.12. Cost

Cushions and mattresses differ widely in pricing. Expensive products are cost–effective in the long run. They are better for a person’s well-being if sores are prevented from forming and the user is saved from the problem of being hospitalised for the same(Medical Devices Agency,2002).

4.3.13. Types of materials used in mattresses, cushions and overlays

4.3.13.1.Air Alternating Cushions/Overlays and Mattresses

These cushions or mattresses have alternate rows of air cells are inflated and deflated sequentially or alternately for a pre-set time period by a mains powered pump. The pressure from a point can be completely removed for a short span of time from any point and the pressure changes continually at a given point. This increases pressure over other areas. It should be taken care that the user can tolerate these variations in pressure. In some models the interval of inflation or deflation can be controlled (Medical Devices Agency,2002).

These devices do not provide stable base like static air cushions and the method of transfer might be considered by the users while using these devices(Medical Devices Agency,2002).

4.3.13.2. Static Air Cushions/Overlays /Mattresses

These mattresses or cushions are air-filled. The pressure-relieving properties are based on the air filled. Regular maintenance is needed to see that inflation is maintained to the correct degree. These cushions are channelled with air through air-filled pathways or balloons. The surface area over which the pressure is distributed can be increased by using the appropriate balloon type. The air circulated through the pathways inside the cushions and moisture and heat are dispersed. Users need to consider their method of transfer as air does not forma stable base(Medical Devices Agency,2002).

4.3.13.3. Overlays/Mattresses/Cushions made with foam

Single/Varied density equipment

Resilience of foam of a cushion affects it pressure relieving quality. There are various sizes, densities and thicknesses of foam cushions. It is possible that foams of different densities can make up a cushion. The differences in the weight of user are accommodated by variations in densities. Foam should be replaced every six to nine months as it deteriorates due to exposure to ultraviolet light or heat. The foam cushion/mattress should be turned regularly on a weekly basis to prolong its pressure relieving properties as well as to increase its life expectancy(Medical Devices Agency,2002). If the foam density is of higher density, then the cushion can last for a longer period. These cushions are light weight and need almost nil maintenance or adjustments.

Convoluted/Cross Cut/Contoured

Greater conformity is allowed by convoluted /cross cut/contoured foam. This typed of foam reduces shear and friction by letting the surface move along with user. These foams increase greater ventilation to the skin compared to the other foams while flat surfaced foams function as insulator thereby increasing skin temperature(Medical Devices Agency,2002). .

Memory foam

This foam models the shape of the body in a better way than standard foam. Conforming or heat sensitive foam with slow memory release models the body shape in a way better than the standard foam(Medical Devices Agency,2002).

Gel Mattresses/Cushions/Overlays

In these products, the weight of the user is distributed over the solid gel or liquid. The pressure is distributed over the whole area as the gel conforms to the body shape. Also the heat is conducted away from the user by the gel making the cushion cool to sit on. In general, gel cushions are heavy unless they are combined with a lightweight material. If the cushions are made with liquid gel, there is high chance that they can leak when the gel cushions get punctured. Gel alone cannot provide stable base for seating, so care should be taken while transfers. Also the method of transfer should considered by the users (Cockbill,Bond,Bersee et al.,1999).

Water mattresses/cushions/overlays

Cushions made with water have less stability than gel cushions though they have more stability than air cushions. These cushions do not provide much support for posture. There is rapid loss of contents in case the cushion is punctured and it is not very easy to move these cushions as they are heavy. When the user is transferring they are not stable (Brienza, Karg,Geyer,et al.,2001).

Combination Filling Overlays/Mattresses/Cushions

These mattresses or cushions contain a combination of pressure relieving materials which are generally arranged in such a way so as to provide stability to the seating base. Combination of materials makes the foam lighter than when it is made of a single material. To achieve optimum pressure relief, the cushions should be positioned correctly. A positioning guide can help the user to meet the purpose (Cockbill,Bond,Bersee et al.,1999).

Air and Liquid Cushions

Foam based gel cushions These cushions have a gel pad on the top of a foam base. Greater stability is provided by foam than gel. These cushions are lighter than gel cushions as the amount of gel in these cushions is small (Brienza, Karg,Geyer,et al.,2001).

Water and foam cushions

These cushions have open foam which is filled with water. Foam makes the cushion conform to the shape of the body .Also it helps to add to stability. These cushions are cold to sit and the skin temperature is reduced. These cushions have a short life span (Cockbill,Bond,Bersee et al.,1999).

Cushions with aperture

These cushions are made up of memory foam, water, gel or any combination of the above. These cushions are designed to provide relief on bath host seat or commode (Cockbill,Bond,Bersee et al.,1999).

5. Assessment of the use of the products

5.1. Planning

The planning process for use of pressure relieving devices starts with seeking an advice from healthcare expert regarding the suitability of a pressure relieving device to the patient depending on his illness and various desirable positions. Factors like material, heat development and thinning out should also be taken into account. If any adjustments are required to nullify such problems, the above arrangements are to be made (Clarke&Oxman, 2000).

5.2. Intervention

Interventions do not cover factors of risk, inspection of skin and patients’ seating and patients’ general positioning which is not related to pressure-relieving devices and aids like gloves filled with air. Even though risk assessment aspects are discussed because of their relation to pressure relieving devices, detailed information about them can be obtained from NICE (2001a) guidelines. Guidelines for gloves filled with water, sheepskins, devices of doughnut type, protectors of limb cushions and seating are due for review. This is because NICE (2001a) guidelines informed that there is no sufficient evidence for sheepskins , wheel chair cushions and protectors pads for limbs as pressure-relieving devices.

5.3. Evaluation

Evaluation is assessment of the effectiveness of the pressure-relieving device. Adequate care might have been taken to select the right type of device for the patient, taking all parameters into association, but in actual utilization, new problems which might not have been earlier expected might crop up and affect the effectiveness of the device. An evaluation of the functioning of the device is therefore necessary and if any problem earlier not expected, cropped up, suitable adjustment for rectification of the same may be made (Chaloner& Cave, 2000).

The following evaluations are considered important
Economic evaluations of pressure-relieving devices taken comparatively. This includes both outcomes and costs (Chaloner& Cave, 2000).
Economic evaluations including cost-benefit analysis, cost utility and cost-effectiveness (Chaloner & Cave, 2000).

5.4. Evidence of uses of products
In general having a consistent finding in a major number of multiple acceptable studies
Either based on a finding which is inconsistent in multiple acceptable studies or based on a single acceptable study.
Scientific evidence that is limited in the absence of directly applicable good quality studies and does not meet all the criteria of acceptable studies. Expert opnion is included in this case.

6. Type of Research and Searches used

6.1. Bibliographic Source

National Collaborating Centre for Nursing and Supportive Care. (2003,October).The use of pressure-relieving devices (beds mattresses and overlays) for the prevention of pressure ulcers in primary and secondary care. London (UK): National Institute for Clinical Excellence (NICE).

6.2. Database Search

To compile data on pressure-relieving devices, nineteen electronic databases were searched using a sensitive search strategy. The electronic search was supplemented by a band search of the specialist wound care journals, conference proceedings and a search of systematic reviews held on the NHS CRD database abstracts of reviews of effectiveness (DARE).

6.3. Methods Used to Collect Evidence
Primary sources including hand searches of literature published
Secondary sources which include hand searches of published literature
Electronic Database Searches.

6.4. Methods Used to Analyze the Evidence
Review with evidence tables in a systematic way.
Randomized controlled trials and their meta-analyses.
Abstraction of data for clinical effectiveness
Methodological quality and its appraisal
Synthesis of data.
Synthesis of evidence and grading.

6.5. Procedure of collecting evidences

Data was extracted into preprepared data extraction tables from data from included trials. All the discrepancies were resolved by discussion. The sources of evidence are
• Criteria of patient inclusion/exclusion
• Care setting
• Group-wise designed key baseline variables
• Number of patients randomized for each intervention and description of the interventions
• Description of standard care/co-interventions
• Outcomes (severity and incidence of new pressure ulcers).
• Reliability and acceptability of devices if reported.

Attempts were made to complete the necessary information for critical appraisal. Attempts were made to contact the authors if data were missing from reports. This is necessary for critical appraisal. The most detailed report was used in data extraction if studies were published more than once.

6.6. Type of Research

The following methods were used in the present type of research
Randomised controlled trials (RCTs) which compared mattresses, overlays and beds for measuring incidence of fresh pressure ulcers are used as outcome measures in objective manner.
Inclusion of economic evaluations was done only if they figured in an RCT.
There were no restrictions on the criterion of year of study, status of publication or language.

7. Conclusion

Pressure ulcers or bed sores is a very innocuous side effect affecting a person who is unable to move from bed or a particular resting position. The problem is not noticed till it occurs. But once it occurs, it compounds the original sickness or medical complications. Pressure-relieving device is an appropriate solution for this problem. There are many devices in the market providing sufficient variety to different types of patients at reasonable costs. Health care personnel would do well to educate the patients about these devices and popularize them.
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