Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Capillary blood flow
研究概览
简要总结
The objective of the current study is to investigate the hemodynamic changes in the peripheral microcirculation system as a response to various changes, using noninvasive thermography and laser doppler
详细描述
This study includes a single session per subject. Microvascular and systemic variables will be monitored in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, increase in local temperature, and changes in the arm position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, between 23 and 45 years of age.
- •Willing to sign informed consent
排除标准
- •Currently smoking
- •Any abnormal skin condition in the area of light irradiation.
- •Pregnant having given birth less than 3 months ago, and/or breastfeeding.
- •Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- •Having any illness that might affect the vasculature, such as diabetes (type I or II)
- •Suffering from significant concurrent illness, such as cardiac disorders or pertinent neurological disorders.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
Red LED
Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag
干预措施: Omnilux new-U (Red LED) (Device)
Red LED
Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag
干预措施: RESPeRATE (Device)
Red LED
Light emitting diodes, 633 nm, 70 mW/cm2, Omnilux new-U (Red LED) (Photomedex, Horsham, PA, USA); RESPeRATE; Heating bag
干预措施: Heating bag (Device)
Near Infrared LED
Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag
干预措施: Omnilux new-U (Near infrared LED) (Device)
Near Infrared LED
Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag
干预措施: RESPeRATE (Device)
Near Infrared LED
Light emitting diodes, 830 nm, 55 mW/ cm2, Omnilux new-U (Near infrared LED) (Photomedex, Horsham, PA, USA); RESPeRATE metronome; Heating bag
干预措施: Heating bag (Device)
结局指标
主要结局
Capillary blood flow
时间窗: Up to 1 hour
Capillary blood flow (red blood cell velocity or flux in 'perfusion units') as measured by laser doppler (Biopac™ System, Inc, USA). This is a continuous measurement (at least 10 Hz sampling rate) from baseline to end of experiment.
次要结局
- Temperature distribution over hands measured by thermography(Up to 1 hour)
- Tissue oxygenation (tcPO2)(Up to 1 hour)