Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 612
- 试验地点
- 8
- 主要终点
- 28-day mortality
研究概览
简要总结
The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.
详细描述
After giving consent to participate in the study, the subjects included in the study will undergo a 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. This StO2 recovery rate will be considered as a reflection of the endothelial health of the patient.
Patients will be studied as soon as possible after admission to the ICU, and followed-up until ICU discharge or death.
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
- 是
入选标准
- •Recent diagnosis of SARS-CoV2 infection
- •Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload.
排除标准
- •Severe peripheral vasculopathy
- •Raynaud's syndrome
- •Skin lesions or trauma in upper limbs interfering the placement of NIRS probe and/or the occlusion tourniquet
- •Deep venous thrombosis in the upper limbs
结局指标
主要结局
28-day mortality
时间窗: 28 days
Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19
次要结局
未报告次要终点
研究者
Jaume Mesquida
MD, PhD
Corporacion Parc Tauli