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| Name | Class |
|---|---|
| Tufts Medical Center | OTHER |
| Medstar Health Research Institute | OTHER |
| Virginia Commonwealth University | OTHER |
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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.
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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Group | Experimental | The RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants. |
|
| reference group-Earlysense system | Active Comparator | The reference device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 and the gold standard device. | 45 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 and the gold standard device. | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Cullinane, MSN | Tufts Medical Center | Principal Investigator |
| Arrel Olano, MD | Medstar Health Research Institute | Principal Investigator |
| Rehan Qayyum, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Health Research Institute | Washington D.C. | District of Columbia | 20782 | United States | ||
| Tufts Medical Center |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2019 | |
| Reset | May 7, 2019 | |
| Release | Jan 31, 2020 | |
| Unrelease | Feb 5, 2020 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2018 | Apr 1, 2019 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2019 | May 7, 2019 | |||
| Jan 31, 2020 | Feb 5, 2020 |
The reference device and Patient Monitor are used to monitor the heart rate (HR) and respiratory rate (RR) of the same participant at the same time in Test 1. The RHEA device and patient monitor are used to monitor the heart rate and respiratory rate of the same participant at the same time in Test 2. The two tests results will be compared and evaluated for the accuracy of the two devices. The RHEA device is used alone to evaluate the accuracy of motion or no motion alarm in Test 3.
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| reference group-Earlysense system | 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. |
|
| 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. |
| 45 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. | 45 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. | 45 days |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298-0102 | United States |