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

NCT03257956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-04-16

No results posted yet for this study

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 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.

Conditions

  • Vital Sign Monitoring

Interventions

DEVICE

Investigational Group

The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.

DEVICE

reference group

The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.

Sponsors & Collaborators

  • Tufts Medical Center

    collaborator OTHER

  • Darma Inc.

    lead INDUSTRY

Principal Investigators

  • Judith Cullinane, MSN · Tufts Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2017-09-20
Completion
2017-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03257956 on ClinicalTrials.gov