Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Darma Inc.
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Root-mean-square Deviation of Heart Rate
研究概览
简要总结
This study compares both of the investigational device and reference device to the gold standard Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary variables for the analysis of heart rate (HR) and respiratory rate (RR) are each of the overall mean roots mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor is evaluated to see if there are equivalent. Motion and bed exit accuracy will be evaluated by comparing with the manual observation.
详细描述
Tests (periods 1 and 2), one of the contact-free devices will be used to monitor the HR and RR, while being compared with the Patient Monitor. The RHEA investigational device and reference device will be used to monitor the same subject at different times, as the sensors of the two devices are placed at a similar location of the bed. HR and RR will be recorded for all three devices.
The primary hypotheses for HR, are as follows:
Adults HO: μ = 3.25 vs. HA: μ < 3.25
The primary hypotheses for RR, are as follows:
Adults HO: μ = 2.25 vs. HA: μ < 2.25 where μ represents the population mean HR or RR. If the upper bound of the confidence interval is less than the hypothesized value, the corresponding null hypothesis will be rejected. Comparison of the performance of the two contract-free devices will be performed on the recorded results via statistical analysis. The hypothesis here is that the two devices have equivalent performance. The third test will assess the ability of the RHEA device to accurately detect motion in or exit from the bed, as compared to the manual observation. Motion and no motion accuracy will each be calculated along with their respective two-sided 95% confidence intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years old and above.
- •Provide written informed consent.
- •Weight ranging from 20 to 150 kg inclusive.
- •Are located in a non-ICU hospital setting.
- •Agree to not eat during the testing period.
- •Agree to keep still.
排除标准
- •Are connected to a device which may interfere with the device monitoring in this study.
- •Are receiving any bedside care which may be incompatible with the study procedures.
- •Sleep apnea.
- •Pregnant or breast feeding.
- •A likely need to receive or undergo a procedure during the testing period.
- •Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
- •A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
- •Are wearing pacemaker or defibrillator.
研究组 & 干预措施
The Rhea Vital Sign Vigilance Device Group
The RHEA device and Philips Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
干预措施: The Rhea Vital Sign Vigilance Device Group (Device)
The Earlysense System Device Group
The reference device -EarlySense System and Philips Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
干预措施: The Earlysense System Device Group (Device)
结局指标
主要结局
Root-mean-square Deviation of Heart Rate
时间窗: 30 days
Calculate the root-mean-square deviation (RMSD) of the heart rate using 20 pairs of valid and synchronously recorded heart rate of investigational device and patient monitor.
Root-mean-square Deviation of Respiratory Rate
时间窗: 30 days
Calculate the root-mean-square deviation (RMSD) of the respiratory rate using 20 pairs of valid and synchronously recorded respiratory rate of investigational device and patient monitor.
次要结局
- Heart Rate t Test Comparison result between the Investigational Device and the Reference Device(30 days)
- Respiratory Rate t Test Comparison result between the Investigational Device and the Reference Device(30 days)
- Motion Notification Accuracy(%)(30 days)
- Bed Exit Notification Accuracy(%)(30 days)