Validation and Usability Study of Intermittent Electrical Simulation (Prelivia) IES in the Management of Pressure Injuries Stage 1 and Stage 2
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Exploratory objective: to develop high level health economic model for pressure injury cost savings
研究概览
简要总结
The focus of this study will be early stage pressure ulcers, which can quickly progress to stage 3, 4 or deep tissue injury The proposed study explores the feasibility of intermittent electrical stimulation (IES),Prelivia, a novel, non-invasive technology in the management of stage 1 and 2 pressure ulcers.
详细描述
Pressure ulcers (also known as pressure injuries or bedsores) constitute a major morbidity in critically ill patients due to immobilization, deranged tissue perfusion, and poor nutrition. It is estimated that the prevalence of pressure injuries is 2.2 to 23.9 percent or higher, depending on the hospital environment, significantly contributing to nosocomial risk and healthcare costs.
Particularly, they are one of the most common complications among people with limited mobility is increased pressure on certain areas of the body causing reduced blood flow and damage to the skin.
There has been extensive research that shows electrical stimulation can be useful in pressure ulcer treatment. (Arora et al, 2020) (5) Electrical stimulation is provided by an electrical current, which can be applied in many ways.
The study intervention applies Intermittent Electrical Stimulation (IES) to the affected area through surface electrodes. The device invokes muscle contractions for 10 seconds every 10 minutes, emulating the subconscious adjustments performed by able- bodied individuals in response to discomfort when seated or lying down. Animal studies demonstrate that IES reduces internal pressure at bone-muscle interfaces (the hypothesized mechanism for injury development), increases tissue oxygenation in surrounding areas, and reduces or eliminates deep tissue injury in muscles subjected to prolonged loading (Appendix A). (6) (L. Solis et al., 2008) (7) Clinical studies support the safety, feasibility, and general acceptability of gluteal IES in human participants. (Appendix B) (Ahmetovic et al., 2015) (8) (Kane et al., 2017) (9) This technology has been studied and has shown, with strong evidence, the capacity of IES to prevent sacral and ischial pressure injuries.
Prelivia uses RHT's patented Intermittent Electrical Stimulation (IES) technology which counteracts damaging tissue compression and increases blood flow to parts of the body that are at risk. Prelivia acts by mimicking the physiological micro-contractions that normally occur in mobile individuals when they fidget or shift their weight. Prelivia works by restoring subconscious muscle contractions and movements, or a 'fidgeting' movement that able-bodied individuals are able do. These muscle contractions increase tissue perfusion - the process in which metabolic waste is removed and fresh blood, oxygen, and nutrients are brought into the tissue. The target muscles(such as the glutei maximi) are electrically stimulated for 10 seconds every 10 minutes to restore adequate tissue perfusion to the surrounding tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent to participate and wear Prelivia for the duration of the study but not longer than 30 days Patients with new or already established stage 1 and 2 pressure injuries BMI <40 Pressure injury location sacral/ischial region
排除标准
- •existing pressure injury above stage 2 and injuries classified as DTI or unstageable continuous neuromuscular blocking drugs & myasthenia gravis: may prevent the ability of IES to induce muscular contraction
- •electrical stimulation to induce muscular contraction
- •presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker
- •unstable spinal, pelvic, or hop fractures that may be displaced by a forced contraction (for sacral and ischial ulcers)
- •rhabdomyolysis
- •skin breakdown or malignant skin involvement over the effected regions that would preclude the use of surface electrodes
- •any implantable electrostimulation device
- •have pacemaker or any other implantable neurostimulation devices,
- •if your pressure injury is above stage 2, or
- •if you are receiving neuromuscular blocking drugs,
- •if you have myasthenia gravis,
- •if you have unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction or
- •if you are wearing an incontinence brief and have frequently loose bowel movements
结局指标
主要结局
Exploratory objective: to develop high level health economic model for pressure injury cost savings
时间窗: 120 days
Measurement of cost to treat patients that developed a severe pressure ulcer compared to those that did not.
To evaluate users' interaction with the device, safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital
时间窗: 30 days
Will assess using qualitative questionnaire for both nursing staff and patient as to comfort and ease of use.
Compare the status and healing time of stage 1 and 2 pressure injuries matched with historical controls via retrospective data review. Historic controls will involve consideration of a various factors:
时间窗: 30 days
Will perform an initial assessment of the wound (e.g. size, narrative description) and compare this pre-intervention with post-intervention after a maximum of 30 days of wear time.
次要结局
未报告次要终点
研究者
Lisa Maks
Diabetes Clinical Nurse Specialist, Adjunct Professor UBC School of Nursing
University of British Columbia