Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients
Completed · Not applicable
Conditions studied: Vital Sign Monitoring
In brief
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.
Key facts
- Study ID
- NCT03332147
- Run by
- Darma Inc.
- People needed
- 80
- Starts
- 2017-11-04
- Expected to finish
- 2018-06-30
- Last updated by the study team
- 2019-04-11
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, 18 years old and above.
- Provide written informed consent.
- Weight ranging from 20 to 150 kg inclusive.
- Are located in a non-ICU hospital setting.
- Agree to not eat during the testing period.
- Agree to keep still.
You may not qualify if…
- Are connected to a device which may interfere with the device monitoring in this study.
- Are receiving any bedside care which may be incompatible with the study procedures.
- Sleep apnea.
- Pregnant or breastfeeding.
- A likely need to receive or undergo a procedure during the testing period.
- Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
- A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
- Are wearing pacemaker or defibrillator.
Where it is running
- Medstar Health Research Institute — Washington D.C., District of Columbia, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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