Status:
COMPLETED
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients
Lead Sponsor:
Darma Inc.
Collaborating Sponsors:
Medstar Health Research Institute
Conditions:
Vital Sign Monitoring
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 M...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03269643
Start Date
September 1 2017
End Date
November 24 2017
Last Update
April 16 2019
Active Locations (1)
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1
MedStar Health Research Institute, Inc.
Washington D.C., District of Columbia, United States, 20770