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
- 15
- 试验地点
- 2
- 主要终点
- RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate
研究概览
简要总结
This study comparing both of the investigational device and reference device to 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 the overall mean root mean square difference (RMSD). Results of the investigational device and reference device compared with the patient monitor are 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
The testing will be conducted in three periods. In the Accuracy 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, Children HO: μ = 3.5 vs. HA: μ < 3.5,
The primary hypotheses for RR, are as follows:
Adults HO: μ = 2.25 vs. HA: μ < 2.25, Children HO: μ = 2.5 vs. HA: μ < 2.5, 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 contact-free devices will be performed on the recorded results via statistical analysis.
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 breastfeeding.
- •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
Investigational Group
The RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
干预措施: Investigational Group (Device)
Reference Group
The reference device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
干预措施: reference group (Device)
结局指标
主要结局
RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate
时间窗: 30 days
Record 20 valid pair heart rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the heart rate for the investigational device.
RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory rate
时间窗: 30 days
Record 20 valid pair respiratory rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the respiratory rate for the investigational device.
次要结局
- Respiratory Rate t Test Comparison result between the Investigational Device and the(30 days)
- Heart 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)