Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- CO Response
研究概览
简要总结
Proof-of-concept observational study including ICU patients undergoing a PLR maneuver. Local microvasculature will be assessed with the hDOS platform on the brachioradialis muscle, deriving the microvascular blood flow index (BFI) and tissue oxygen saturation (StO2). CO will be assessed via an invasive hemodynamic monitor based on pulse waveform analysis through the patient's arterial line. The correlation over time between CO and microvascular parameters, and the ability of microvascular variables for predicting a positive CO response (increase > 10%) will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invasive blood pressure monitoring through an arterial line
排除标准
- •Patients with suspected pregnancy
- •Intra-abdominal hypertension
- •Elevated intracranial pressure
研究组 & 干预措施
Critical care patient
Critical care patients with their blood pressure invasively monitored through an arterial line
干预措施: Passive Leg Raising maneuver (Other)
结局指标
主要结局
CO Response
时间窗: During procedure
The relative increase in % of the CO, from baseline during the PLR (at 60-120 seconds within the maneuver), will be calculated. Those subjects with a relative increase equal to or above 10% will be classified as CO-responders to the PLR. On the other hand, if the increase in CO during the PLR is below 10%, subjects will be classified as non-responders.
Cardiac Output Response
时间窗: During procedure
The relative increase in % of the Cardiac Output (CO), from baseline during the Passive Leg Raising (PLR) test (at 60-120 seconds within the maneuver), will be calculated. Those subjects with a relative increase equal to or above 10% will be classified as CO-responders to the PLR. On the other hand, if the increase in CO during the PLR is below 10%, subjects will be classified as non-responders.
次要结局
未报告次要终点
研究者
Jaume Mesquida
Senior Clinical Researcher
Corporacion Parc Tauli