Comparison of Intraoperative Heart Rate and Respiratory Rate Acquired Via ATLASense Raphael Polymonitor and Standard Intraoperative Monitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Respiratory Rate (RR)
研究概览
简要总结
The aim of this observational comparison study is to compare the HR and respiratory RR of intraoperative surgical patients simultaneously recorded by standard intraoperative monitors and the ATLASense RAPHAEL PolyMonitor. A second aim is to determine the extent of data loss and data gap duration, and validate the PolyMonitor alert system for tachycardia and bradycardia. Additional parameters of non-invasive blood pressure (NIBP) and body temperature will also be compared between the PolyMonitor and standard intraoperative monitors. Finally, this study will provide insight into the logistics of intraoperative use of the PolyMonitor.
详细描述
The ATLASense Raphael PolyMonitor will be placed on the patient's left chest mid sternal line in the operating room. Traditional physiologic monitors described above will also be placed on the patient in the operating room. Data will be collected via the ATLASense system and through the traditional operating room monitors, and this data will be time matched through synchronization of the monitors post hoc. The time matched data pairs will undergo statistical analysis post hoc. It is anticipated that this study will validate the intraoperative HR and RR measured through the ATLASense Raphael PolyMonitor, providing adequate data points for statistical analysis with 95% limits of agreement, bias, and data loss/gaps. Success is also the logistical lessons learned for using this monitor in the intraoperative setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking
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
- •English speaking
- •Adult males or females (above the age of 18)
- •Scheduled to undergo general anesthesia during elective surgery
排除标准
- •Pregnant adult female
- •Thoracic surgery
- •Left lateral decubitus positioning required during procedure
- •Surgery involving the left flank, or requiring surgical field involving the left flank
- •Surgery involving the left chest, or requiring surgical field involving the left chest
- •Allergy to adhesives
- •Open wound, rash, or sore involving the left chest
- •Presence of cardiac defibrillator, or pacemaker
结局指标
主要结局
Respiratory Rate (RR)
时间窗: Entire duration of surgery
Minute-by-minute respiratory rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
Heart Rate (HR)
时间窗: Entire duration of surgery
Minute-by-minute heart rate measures taken by both the ATLASense RAPHAEL PolyMonitor and the standard intraoperative monitor
次要结局
- Blood Pressure (Mean Arterial Pressure)(Entire duration of surgery)
- Gaps in Data Collection(Entire duration of surgery)
- Core Body Temperature(Entire duration of surgery)
研究者
Trevor J. Szymanski MD, MBA
Senior Staff Anesthesiologist
Henry Ford Health System