Clinical trialNCT03332147CompletedInterventional

Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients

SponsorDarma Inc.Enrollment80Vital Sign Monitoring

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Arrel Olano, MD
Medstar Health Research Institute
Principal Investigator
clinicaltrials.gov ↗
Judith Cullinane, MSN
Tufts Medical Center
Principal Investigator
clinicaltrials.gov ↗
Rehan Qayyum, MD
Virginia Commonwealth University
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 4 Nov 2017
Primary completion: 25 May 2018
Completion: 30 Jun 2018
Last update posted: 11 Apr 2019
Registered enrollment: 80
Registry id: NCT03332147

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.