Continued Development of a Multiplex Precision Medicine System for Early Warning of Progression Toward Hemodynamic Deterioration After Trauma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Algorithm Performance: Positive Predictive Value for Alarm/no Alarm Outcome
研究概览
简要总结
This study is Phase 3 of a three-phase DOD CDMRP funded project for the development of a multi-technology poly-anatomic noninvasive system for early detection of occult hemorrhage.
Early detection of ongoing hemorrhage (OH) before onset of shock is a universally acknowledged great unmet need, and particularly important after trauma. 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 with an acceptable rate of false-positives and false-negatives would save countless lives. Additionally, such technology would save significant time, money and effort by allowing medical resources to be applied more accurately - the essence of precision medicine. An automated system would monitor currently stable patients continuously, leaving clinicians free to care for patients in need of attention.
详细描述
The investigators will enroll 480 trauma patients in a "no significant risk" prospective clinical trial to 1) evaluate the performance of a Mark I prototype, 2) validate the performance of the Phase II algorithm, and 3) re-train the algorithm to Phase III iteration.
This is not a therapeutic study. 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.
As a minimal risk study, there will be no change from standard of care for patients undergoing surgery. The surgical procedures and pharmacotherapies will proceed as per standard clinical management.
Enrolled patients will undergo standard preoperative, anesthetic, and postoperative physiological monitoring that includes:
Electrocardiogram: Heart rate and electrical activity of the heart will be recorded via a 3-lead ECG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Awake and alert GCS >14
- •Admission systolic blood pressure greater than 90 and heart rate less than 120
- •Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
排除标准
- •Altered mental status GCS < 13
- •Systolic blood pressure less than 90 or heart rate greater than 120
- •Need for ongoing fluid or pressor support (standard local fluid resuscitation only)
- •Clinically significant ongoing external hemorrhage
- •Respiratory distress with O2 saturation <96%
- •Pre-existing systemic illness, likely to alter systemic cardiovascular response to hemorrhage (overt clinical heart failure). Including congestive heart failure, and a paced cardiac rhythm.
- •Prisoner status
研究组 & 干预措施
Trauma Patients
Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
- Awake and alert GCS >14
- Admission systolic blood pressure greater than 90 and heart rate less than 120
- Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
干预措施: Detection of Occult Hemorrhage in Trauma Patients (Device)
结局指标
主要结局
Algorithm Performance: Positive Predictive Value for Alarm/no Alarm Outcome
时间窗: patient data will be collected over 3-6 hours
Algorithm Performance: Time of Alarm Before Onset of Deterioration
时间窗: patient data will be collected over 3-6 hours
Algorithm Performance: Specificity as Measured by for Alarm/no Alarm Outcome
时间窗: patient data will be collected over 3-6 hours
Algorithm Performance: Sensitivity as Measured by for Alarm/no Alarm Outcome
时间窗: patient data will be collected over 3-6 hours
Algorithm Performance: Negative Predictive Value for Alarm/no Alarm Outcome
时间窗: patient data will be collected over 3-6 hours
次要结局
未报告次要终点