Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Correlation and Validation of data
研究概览
简要总结
This study is designed as an observational study to collect Cardiospire cardiogenic oscillation signal (COS) and CO output parameters from the Pulmonary Artery Catheter in intubated patients.
详细描述
Respirix has developed a non-invasive hemodynamic monitoring device called the Cardiospire. The Cardiospire detects minor, cyclic waveforms caused by Cardiogenic Oscillations (COS) and uses features of the COS waveform to provide information about hemodynamics.
This study is designed as an observational study to collect paired readings of the Cardiospire cardiogenic oscillation signal (COS) and the ground truth CO output parameters, including Pulmonary Artery Pressure diastolic (PAPd), systolic (PAPs), Stroke Volume (SV), and Cardiac Output (CO) from the Pulmonary Artery Catheter in intubated patients.
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
- •≥ 18 years of age
- •Intubated
- •Pulmonary artery catheter
- •Patient or patient's legally authorized representative is able to provide informed consent
排除标准
- •Subjects who, at the principal investigator's determination, would not be appropriate for this study
结局指标
主要结局
Correlation and Validation of data
时间窗: 1.5 years
Collected Cardiospire data from next 150 patients will be analyzed in comparison to PAC data for correlation and validation purposes.
Repeatable Data Verification
时间窗: 3 months
First 10 patient Cardiospire data will be processed and analyzed to determine if deemed repeatable for cardiogenic oscillations (COS).
次要结局
未报告次要终点