Vital Sign Monitoring Clinical Trial
Official title:
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
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.
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.
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