Pilot Study to Assess the Effects of Haemodialysis Treatments on Blood Flow to the Ear
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- change in ear blood flow
研究概览
简要总结
This is a prospective observational pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis.
详细描述
10 patients, attending for thrice weekly outpatient haemodiafiltration shall be studied during a dialysis session using a CE marked commercially available digital otoscope capable of recording digital videos of the tympanic membrane and ear canal.
Patients will receive standard clinical care and monitoring of their dialysis session, which includes recording of blood pressure and changes in haematocrit and volume status during dialysis and noting patient symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 years and older up to 80 years
- •Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
- •Able to provide written informed consent obtained
排除标准
- •Patients unable to provide written informed consent
- •Patients using hearing aids
- •Patients who have had previous middle ear surgery
- •Patients not fulfilling inclusion criteria
结局指标
主要结局
change in ear blood flow
时间窗: day 1 dialysis session
percentage change in ear blood flow compared to initial ear blood flow
次要结局
- change in blood pressure(day 1 dialysis session)
- change in haematocrit volume status(day 1 dialysis session)
- record of hypotensive episodes during dialysis(day 1 dialysis session)