Vital Sign Monitoring Clinical Trial
Official title:
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Verified date | April 2019 |
Source | Darma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 20, 2017 |
Est. primary completion date | September 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Darma Inc. | Tufts Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 30 days | |
Primary | 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. | 30 days | |
Secondary | 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. | 30 days | |
Secondary | Respiratory Rate t Test Comparison result between the Investigational Device and the | 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. | 30 days | |
Secondary | 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. | 30 days | |
Secondary | 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. | 30 days |
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