NCT04328246终止3 期
The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Clinical course of pressure injury over time
研究概览
简要总结
The proposed study assesses the superiority of IES supplementation to the standard of care alone (offloading pressure every two hours) in improving the prevention and treatment of sacral and ischial pressure injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Modified Braden Scale score of 14 or less. The Modified Braden Scale score is calculated as follows:
- •Braden Scale score (Ranges from 6 to 23)
- •1 for Low Serum Albumin
- •1 for Type II Diabetes
- •Anticipated length of stay of at least 4 days
- •Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf.
排除标准
- •Existing pressure injuries above Stage II and injuries classified as DTI or unstageable
- •Neuromuscular blocking drugs & myasthenia gravis: may prevent the ability of electrical stimulation to induce muscular contraction
- •Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction
- •Rhabdomyolysis
- •Use of a Pacemaker
- •Skin breakdown over the gluteal regions that would preclude the use of surface electrodes.
结局指标
主要结局
Clinical course of pressure injury over time
时间窗: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Chauhan Weighted Trajectory Analysis (CWTA) will be used to compare the morbidity associated with sacral and ischial pressure injuries through time. A one-sided Chauhan logrank test at a significance of 0.05 will be used to assess for superiority of the experimental arm over the control arm.
次要结局
- Cox Regression Analysis(Final analysis will be performed at end of study (expected completion 2 years))
- Relative Risk(Final analysis will be performed at end of study (expected completion 2 years))
- Clinical course of pressure injury in subgroups(Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.)
- Kaplan-Meier Time-to-Event Analysis(Final analysis will be performed at end of study (expected completion 2 years))
- Description of adverse events related to IES(Final analysis will be performed at end of study (expected completion 2 years))
- Observed Counts of Pressure Injuries(Final analysis will be performed at end of study (expected completion 2 years))
- Onset Time(Final analysis will be performed at end of study (expected completion 2 years))
- Duration of Inpatient Stay(Final analysis will be performed at end of study (expected completion 2 years))
研究者
研究点 (2)
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