Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients

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.

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 on 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.

• Investigational Group (Device): The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
• Reference group (Device): The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.

Primary outcomes

• RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate [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 [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.

Secondary outcomes

• Heart Rate t Test Comparison result between the Investigational Device and the Reference Device [30 days]: Record 20 valid heart rate displayed in the reference device and patient monitor at the same time every one minute. Calculate the t test results for heart rate for the reference device and the investigational device.
• Respiratory Rate t Test Comparison result between the Investigational Device and the Reference Device [30 days]: Record 20 valid respiratory rate displayed in the reference device and patient monitor at the same time every one minute. Calculate the t test results for respiratory rate for the reference device and the investigational device.
• Motion Notification Accuracy(%) [30 days]: Record the time for each instructed movements from manual observation and time for movements notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.
• Bed Exit Notification Accuracy(%) [30 days]: Record the time for each instructed bed exit from manual observation and time for bed exit notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.

Sex: All

Inclusion Criteria:

1. Male or female, 18 years old and above.
2. Provide written informed consent.
3. Weight ranging from 20 to 150 kg inclusive.
4. Are located in a non-ICU hospital setting.
5. Agree to not eat during the testing period.
6. Agree to keep still.

Exclusion Criteria:

1. Are connected to a device which may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. Sleep apnea.
4. Pregnant or breastfeeding.
5. A likely need to receive or undergo a procedure during the testing period.
6. Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
7. A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
8. Are wearing pacemaker or defibrillator.

• Study Protocol and Statistical Analysis Plan (PDF, 2017-07-07)

• Arrel Olano, MD, Principal investigator, Medstar Health Research Institute