跳至主要内容
临床试验/NCT04814810
NCT04814810终止不适用

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

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Norman A. Paradis

Professor of Surgery; Emergency Medicine Physician

Dartmouth-Hitchcock Medical Center

研究点 (1)

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