BWH Critical Care Study of CareGuide for Evaluation of Emerging or Established Shock
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Peak systemic lactate
研究概览
简要总结
This pilot study aims to examine the relationship between continuously measured CareGuide™ muscle oxygen saturation (SmO2), tissue pH and data provided from standard monitoring techniques during the care of subjects with suspected established (Cohort A) or emerging (Cohort B) shock in the intensive care unit (ICU).
详细描述
Approximately 50 subjects meeting recruitment criteria will be enrolled with a minimum of 20 subjects meeting entry criteria for established shock (Cohort A).
Noninvasive near-infrared spectroscopy CareGuide™ measurements of SmO2, tissue pH and hematocrit will be collected from enrollment through device removal. These data will be compared to specific hemodynamic and laboratory parameters obtained as a part of routine care during the CareGuide™ monitoring period.
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
- •Subjects who are:
- •To be admitted to the intensive care unit
- •At least 18 years of age
- •Men or Women
- •Informed consent from subject or surrogate
- •Clinical diagnosis of established (Cohort A) or emerging (Cohort B) shock, as described above.
排除标准
- •Subjects with:
- •Body mass index >37
- •Trauma (primary diagnosis)
- •Non-global conditions leading to regional increased lactate production (e.g. isolated thrombotic or embolic phenomena, limb, compartment syndrome)
- •Known untreated hypothyroidism
- •Known hypersensitivity to medical adhesives
- •Suspected carbon monoxide poisoning or methemoglobinemia
- •Goals of care restricting vital sign acquisition
- •Family member of investigators or study staff
结局指标
主要结局
Peak systemic lactate
时间窗: Duration of monitoring (< 1 week)
Cohort A
次要结局
- Peak systemic lactate(Duration of monitoring (< 1 week))
- Systemic pH(Duration of monitoring (< 1 week))
- Temporal assessment of SmO2 and lactate(Duration of monitoring (< 1 week))
- Standard hemodynamic measures stratified by shock type (cardiogenic, hypovolemic, distributive)(Duration of monitoring (< 1 week))
研究者
Stephen D. Wiviott
Associate Professor of Medicine
Brigham and Women's Hospital