NCT05985525招募中不适用
Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS): Prospective Observational Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor microvascular function in critically ill patients.
详细描述
This is a prospective observational study using non-invasive NIRS for microvascular monitoring in the ICU. The study involves no interventions above standard of care other than the application of the NIRS monitors.
NIRS will be applied to skeletal muscle and the brain longitudinally throughout ICU admission. Vital signs are extracted continuously from the ICU monitor and clinical data are recorded from patient records.
The broad goals of the study are:
- Determine the feasibility of longitudinal NIRS monitoring in ICU patients
- Determine the ability to derive patient-specific microvascular metrics using NIRS
- Explore the relationship between microvascular metrics and ICU mortality
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
- •Admitted to ICU
- •Receiving invasive mechanical ventilation
排除标准
- •Body Mass Index >40
- •More than 24 hours has elapsed since ICU admission
- •Death is deemed to be imminent and inevitable during the next 24 hours
- •Known allergy to the textile components of the device
- •Significant clinical jaundice, ecchymosis
- •COVID positive microbiological result
- •The treating clinician believes that participation in the domain would not be in the best interests of the patient
- •Consent declined from patient or authorized third party
结局指标
主要结局
Recruitment
时间窗: 30 days
Recruitment of two patients per month from each study site
次要结局
- protocol adherence(14 days)
- NIRS and vital sign data quality(14 days)
- Optimal Map (MAPopt) derivation(14 days)
研究者
Asher Mendelson
Assistant Professor
University of Manitoba
研究点 (1)
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