An interventional study of Investigational Group and Reference group in Vital Sign Monitoring, sponsored by Darma Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Darma Inc. · Not applicable, Interventional, and Screening
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.
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.
Exclusion Criteria:
The RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
Device: Investigational Group
The reference device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
Device: Reference group
The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
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.
RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate
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.
Time frame: 30 days
RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory rate
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.
Time frame: 30 days
Heart Rate t Test Comparison result between the Investigational Device and the Reference Device
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.
Time frame: 30 days
Respiratory Rate t Test Comparison result between the Investigational Device and the Reference Device
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.
Time frame: 30 days
Motion Notification Accuracy(%)
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.
Time frame: 30 days
Bed Exit Notification Accuracy(%)
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.
Time frame: 30 days
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Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Darma Inc.