NCT02602782已完成不适用
Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients
Potrero Medical0 个研究点目标入组 76 人开始时间: 2016年2月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Comparison of physiologic signals as measured by the Accuryn Monitoring System compared to existing gold standard measurements.
研究概览
简要总结
The purpose of the study is to collect physiologic data streams with the Accuryn Monitoring System and validate the accuracy of these measurements against existing gold standards, and to track and analyze changes in these physiologic data streams to identify clinical signatures that may enable earlier diagnosis and intervention of critical conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Admission to the hospital with trauma (including burn)
- •Anticipated ICU stay of at least 72 hours
- •Anticipated transfusion of ≥1 unit blood products (pRBC's, platelets, and/or plasma) within the first 24 hours of hospitalization, and/or a current diagnosis of sepsis/septic shock, and/or ICU admission primarily for burn
- •Anticipated requirement for a urinary bladder catheter for ≥ 72 hours
排除标准
- •Inability to receive a 16F urinary bladder catheter
- •Significant bladder or urethral injury
- •In the opinion of the investigator the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications
- •Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial
- •Pregnancy known at the time of presentation
结局指标
主要结局
Comparison of physiologic signals as measured by the Accuryn Monitoring System compared to existing gold standard measurements.
时间窗: During the ICU stay (approximately 2-4 weeks)
次要结局
未报告次要终点
研究者
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