Clinical Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure Against Invasive Arterial Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Accuracy
研究概览
简要总结
To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.
详细描述
Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor
Main study:
Validate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements.
Up to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.
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
- •Clinical indication for arterial catheter insertion;
- •Age ≥18 years;
- •American Society of Anesthesiologists (ASA) physical status class ≤3;
- •Enrollment will be adjusted as necessary so the final population includes at least 40% men and 40% women;
- •Planned length of surgery >60 minutes;
- •Anticipated supine positioning;
- •Anticipated initial recovery in the post-anesthesia care unit.
- •Exclusion criteria:
- •Severe peripheral vascular disease;
- •Surgery that involves manipulation of large arteries
- •Bypass surgery
- •Positive Allen's test
- •Inability to insert a catheter into an upper extremity artery;
- •Patients with an arterial-venous shunt for hemodialysis;
- •Inability to measure NIBP on the arm with the arterial catheter;
- •Atria l fibrillation;
- •Body Mass Index (BMI) >35kg/m2;
- •Esophageal or nasopharyngeal pathology, coarctation of the aorta;
- •Emergency surgery.
- •Surgery which involves manipulation of major arteries
排除标准
- 未提供
结局指标
主要结局
Accuracy
时间窗: During hospital admission
The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures.
次要结局
- Change(During hospital admission)
- Calibration Duration(During hospital admission)
- Gender and Fitzpatrick index(During hospital admission)