Short-term Effects of Prone Positioning on Tissue Oxygen Saturation, Measured by Near-infrared Spectroscopy, in COVID-19 Patients With Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Change in local hemoglobin content (THC)
研究概览
简要总结
The purpose of this study is to monitor short-term changes in tissue oxygen saturation and local blood flow as results of changing from supine to prone position in ARDS COVID-19 patients
详细描述
After obtaining consent to participate in the study, the subjects included in the study will undergo a baseline 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus.
Tissue oxygenation measurements will be performed in supine position, immediately before changing to prone positioning, and repeated after 20 minutes of stabilization, once in prone position.
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
- •COVID-19 patients admitted in the ICU receiving invasive mechanical ventilation and requiring prone positioning for severe hypoxemia management, as decided by the medical team
排除标准
- •Severe peripheral vasculopathy
- •Raynaud's syndrome
- •Skin lesions/trauma in upper limbs interfering the placement of the NIRS probe and/or the occlusion tourniquet
- •Deep venous thrombosis in the upper limbs
结局指标
主要结局
Change in local hemoglobin content (THC)
时间窗: 20 minutes
THC is measured as microMols
Change in tissue oxygenation (StO2)
时间窗: 20 minutes
Tissue oxygenation is measured as percent of oxyhemoglobin over total hemoglobin content in the sensed area (skeletal muscle)
次要结局
- Compare changes in tissue oxygenation (StO2) and arterial oxygenation (SaO2)(20 minutes)
研究者
Jaume Mesquida
Principal Investigator
Corporacion Parc Tauli