Pilot Study: Influence of Ischemic Preconditioning on the Orthostatic Competence of the Microcirculation in the Lower Extremity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Microcirculation parameters
研究概览
简要总结
The goal of this clinical trial (pilot study) is to learn about the microcirculatory regulation of the lower extremity under orthostatic stress with and without RIC - Remote Ischemic Preconditioning in healthy participants. The main question it aims to answer are:
Do the beneficial effects of RIC withstand orthostatic stress? / Does RIC benefit lower extremity microcirculation in ortho-statically stressed subjects? Is there a relationship/correlation between the variables of microcirculation and hemodynamics in the context of RIC and orthostatic loading?
详细描述
The use of free flaps is a standard procedure in reconstructive plastic surgery, in which a wide variety of tissue units are microsurgically transplanted, often to cover defects on the body surface. Microvascular tissue transplants depend on an adequate blood supply, which is particularly vulnerable in the first postoperative phase. In the case of reconstructions of the lower extremities in particular, the flap perfusion is stressed during the first mobilizations due to the orthostatic load. For this reason, the mobilization of the patients is gradually increased from day to day with precise monitoring of the blood flow (so-called flap training).
A procedure for temporarily improving the blood flow in free flaps is ischemic preconditioning (RIC - Remote Ischemic Preconditioning). Repeated, short cycles of ischemia/reperfusion applied to a circumscribed vascular territory (e.g. supra systolic tourniquet arm) lead to an increase in tissue perfusion, even outside the area of application (arm).
RIC could have the potential to optimize the tissue perfusion of flaps even under orthostatic stress and to promote an earlier mobilization of patients. Our work investigates the influence of RIC on orthostatic competence (as part of a standardized orthostatic load with a tilting table) of the microcirculatory system in the lower extremities and the orthostatic hemodynamic regulation itself.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the study design, randomization and blinding are not possible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers
- •No diseases relevant to circulation and blood flow (arterial hypertension, peripheral arterial occlusive disease, chronic venous insufficiency)
- •Subjects must be capable of insight. Anyone who can understand the nature, significance, and scope of the clinical trial and determine their will accordingly is capable of insight.
排除标准
- •Non-consent
- •Lack of compliance
- •Syncope tendency
结局指标
主要结局
Microcirculation parameters
时间窗: continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment
Microcirculation parameter (Measured with O2C laser Doppler and tissue spectrometry LEA Medizintechnik GmbH, Giessen, Germany) Relative blood flow in arbitrary units \[AU\]
次要结局
- Microcirculation parameters - oxygen saturation(continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment)
- Microcirculation parameters - Relative amount of hemoglobin(continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment)
- Hemodynamics(continuous measurement; Focus on the following periods: 1 minute before RIC, 1 min before the tilting table, half-time minute in the upright position, 1 min before the end of the measurment)
研究者
Peter Paul Pfeiler, MD
chief resident
ISAR Klinikum