Development of a Multiplex Precision Medicine System for Early Warning of Progression Toward Shock After Trauma: Non-invasive Measurement During Hepatectomy With Low Central Venous Pressure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Non-invasive measurements that will be used for machine learning
研究概览
简要总结
Early detection of ongoing hemorrhage (OH) before onset of hemorrhagic shock is a universally acknowledged great unmet need, and particularly important after traumatic injury. Delays in the detection of OH are associated with a "failure to rescue" and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. An early alert to the presence of OH would save countless lives.
This is a single site study, enrolling 48 patients undergoing liver resection in a "no significant risk" prospective clinical trial to: 1) further identify a minimal subset of noninvasive measurement technologies necessary for the desired diagnostic performance, 2) validate the performance of our Phase I algorithm, and 3) re-train the algorithm to a Phase II human iteration.
The main outcome variables are non-invasive measurements that will be used for machine learning, not real-time patient management. The data generated will be used later for discovery and validation in traditional and innovative machine learning.
详细描述
Hemorrhagic shock remains a leading cause of death on the battlefield as well in civilian communities. Early detection of ongoing hemorrhage before progression to frank shock would allow early intervention. It is widely appreciated that the classic medical vital signs perform poorly until late in the progression to shock after traumatic injury. Currently available techniques, including intermittent vital sign monitoring, laboratory analysis, and single measurement devices have poor performance before clinically obvious physiologic distress.
The overall goal of this project is to develop a multi-technology noninvasive system for early detection of ongoing hemorrhage. The underlying hypothesis is that deep learning developed algorithms obtaining diagnostic signals from multiple sources will outperform single technology solutions.
While the promise of innovative noninvasive testing has received wide attention, development of effective bedside technologies has thus far been limited and their performance disappointing. In 2014, Kim et al stated that "The results from this meta-analysis found that inaccuracy and imprecision of continuous noninvasive arterial pressure monitoring devices are larger than what was defined as acceptable" and noninvasive blood pressure measurement is among the most fully developed of these technologies. The failure of noninvasive technologies in the detection or diagnosis of complex disease states has been essentially complete. The investigators believe that this failure reflects the limitations of uniplex systems (a single sensor in a single-location) and patient-to-patient variation in physiologic response. Uniplex systems sacrifice the entire diagnostic signal in anatomic-temporal patterns, which likely has significant discriminant power.
To date, technological innovation in early detection of ongoing hemorrhage has been of two broad categories: 1) a search to discover a single new measurement of tissue or organ status or 2) application of more sophisticated mathematical techniques based on machine learning and signal processing.
The investigators propose to develop a system that combines state-of-the-art noninvasive sensing technologies and advanced multivariable statistical algorithms. This system will be developed from its inception to be inexpensive and easily applied, even in austere settings.
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
- •Adults 18 years or older
- •Patients undergoing liver resection.
- •Ability to give informed consent.
排除标准
- •Pre-existing systemic illness, likely to alter systemic cardiovascular response to hemorrhage. Including congestive heart failure, and a paced cardiac rhythm.
- •Prisoner status
结局指标
主要结局
Non-invasive measurements that will be used for machine learning
时间窗: 2-3 hours
Intrathoracic Hemodynamic Bioreactance Signatures
次要结局
未报告次要终点
研究者
Norman A. Paradis
Professor of Surgery; Emergency Medicine Physician
Dartmouth-Hitchcock Medical Center
