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

NCT03332147 | Completed FDA Device

• 1 other identifier: RHEA EL30-2017-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Vital Sign Monitoring

Outcome Measures

Primary Outcomes (2)

• RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate

  Record 20 valid pair heart rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the heart rate for the investigational device and the gold standard device.

  45 days

• RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory rate

  Record 20 valid pair respiratory rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the respiratory rate for the investigational device and the gold standard device.

  45 days

Secondary Outcomes (4)

• Heart Rate t Test Comparison result between the Investigational Device and the Reference Device

  45 days

• Respiratory Rate t Test Comparison result between the Investigational Device and the reference device

  45 days

• Motion Notification Accuracy(%)

  45 days

• Bed Exit Notification Accuracy(%)

  45 days

Study Arms (2)

Investigational Group

EXPERIMENTAL

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

Device: Investigational Group

reference group-Earlysense system

ACTIVE COMPARATOR

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

Device: reference group-Earlysense system

Interventions

Investigational Group DEVICE

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

Investigational Group

reference group-Earlysense system DEVICE

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.

reference group-Earlysense system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Darma Inc.: lead
• Tufts Medical Center: collaborator
• Medstar Health Research Institute: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (3)

Medstar Health Research Institute

Washington D.C., District of Columbia, 20782, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298-0102, United States

Location

Study Officials

• Judith Cullinane, MSN

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Arrel Olano, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

• Rehan Qayyum, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The reference device and Patient Monitor are used to monitor the heart rate (HR) and respiratory rate (RR) of the same participant at the same time in Test 1. The RHEA device and patient monitor are used to monitor the heart rate and respiratory rate of the same participant at the same time in Test 2. The two tests results will be compared and evaluated for the accuracy of the two devices. The RHEA device is used alone to evaluate the accuracy of motion or no motion alarm in Test 3.

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 6, 2017
• Study Start: November 4, 2017
• Primary Completion: May 25, 2018
• Study Completion: June 30, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)