Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease. An Experimental Study to Investigate the Optimal Pulse Pressure Regime to Improve Blood Flow.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Arterial blood flow
研究概览
简要总结
Recent studies have shown that applying intermittent negative pressure (INP) with short negative pressure (-40 mmHg) pulses to the lower extremities increase arterial blood flow velocity and skin blood flow. However, the optimal magnitude of negative pressure to improve blood flow is not known, and needs further investigation. Peripheral arterial blood flow velocity, skin blood flow and skin temperature in the foot will be recorded at different levels of oscillating negative pressure to identify a pressure range which is practically, while at the same time induce clinically relevant changes in blood flow parameters. Heart rate and blood pressure will be recorded to monitor the effects on the central circulation.
详细描述
Cross sectional study design. The equipment for physiological measurements will be attached to the patient, and the foot will then be placed in the pressure chamber. The device induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure. Pressure levels of 0 mmHg, -10mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested.
Patients will be recruited from the out-patient clinic at Department of Vascular Surgery, Oslo University Hospital, Aker.
Inclusion criteria:
Diagnosed peripheral artery disease (PAD), Ankle-Brachial Index <0.9 Outcome measures:
Arterial blood flow: Ultrasound Doppler from peripheral arteries in the foot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 96 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed peripheral artery disease
- •Ankle-Brachial Index <0.9
排除标准
- •Incapable to make an informed consent
- •Diagnosis of severe psychiatric disease
- •Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
- •Systemic infection
- •Use of vasoactive substances
结局指标
主要结局
Arterial blood flow
时间窗: At time of intervention
Continuously Ultrasound Doppler measurements of the dorsalis pedis artery or tibialis posterior artery to monitor changes in arterial blood flow during 5 min sequences of intermittent negative pressure treatment. Pressure levels of 0, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested. Systolic pressures in the arm and the ankle will be assessed before the intervention to describe the patients severity of disease.
次要结局
- Skin blood flow(At time of intervention)
研究者
Jonny Hisdal
Principal Investigator
Oslo University Hospital