Status:
COMPLETED
Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients
Lead Sponsor:
Darma Inc.
Collaborating Sponsors:
Virginia Commonwealth University
Conditions:
Vital Sign Monitoring
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 fo...
Detailed Description
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...
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 breast feeding.
- 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 :
May 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03356184
Start Date
May 11 2018
End Date
May 15 2018
Last Update
April 16 2019
Active Locations (1)
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1
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298-0102