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

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

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.

Study Overview

• Status: Completed
• Conditions: Vital Sign Monitoring
• Intervention / Treatment: Device: Investigational Group; Device: Reference group

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 Monitor. The RHEA investigational device and reference device will be used to monitor the same subject at different times, as the sensors of the two devices are placed at a similar location of the bed. HR and RR will be recorded for all three devices.

The primary hypotheses for HR, are as follows:

Adults HO: μ = 3.25 vs. HA: μ < 3.25, Children HO: μ = 3.5 vs. HA: μ < 3.5,

The primary hypotheses for RR, are as follows:

Adults HO: μ = 2.25 vs. HA: μ < 2.25, Children HO: μ = 2.5 vs. HA: μ < 2.5, where μ represents the population mean HR or RR. If the upper bound of the confidence interval is less than the hypothesized value, the corresponding null hypothesis will be rejected. Comparison of the performance of the two contact-free devices will be performed on the recorded results via statistical analysis.

The hypothesis here is that the two devices have equivalent performance. The third test will assess the ability of the RHEA device to accurately detect motion on or exit from the bed, as compared to the manual observation. Motion and no motion accuracy will each be calculated along with their respective two-sided 95% confidence intervals.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20770
      • MedStar Health Research Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, 18 years old and above.
2. Provide written informed consent.
3. Weight ranging from 20 to 150 kg inclusive.
4. Are located in a non-ICU hospital setting.
5. Agree to not eat during the testing period.
6. Agree to keep still.

Exclusion Criteria:

1. Are connected to a device which may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. Sleep apnea.
4. Pregnant or breastfeeding.
5. A likely need to receive or undergo a procedure during the testing period.
6. Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
7. A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
8. Are wearing pacemaker or defibrillator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Group; The RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.	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.
Active Comparator: Reference Group; The reference device and Patient Monitor Device 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate t Test Comparison result between the Investigational Device and the Reference Device	Record 20 valid heart rate displayed in the reference device and patient monitor at the same time every one minute. Calculate the t test results for heart rate for the reference device and the investigational device.	30 days
Respiratory Rate t Test Comparison result between the Investigational Device and the Reference Device	Record 20 valid respiratory rate displayed in the reference device and patient monitor at the same time every one minute. Calculate the t test results for respiratory rate for the reference device and the investigational device.	30 days
Motion Notification Accuracy(%)	Record the time for each instructed movements from manual observation and time for movements notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.	30 days
Bed Exit Notification Accuracy(%)	Record the time for each instructed bed exit from manual observation and time for bed exit notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.	30 days

Collaborators and Investigators

• Sponsor: Darma Inc.
• Collaborators: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): November 24, 2017
• Study Completion (Actual): November 24, 2017

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Heart Rate; Vital Sign; Vigilance System
• Other Study ID Numbers: RHEA EL30-2017-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No