NCT03356184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 11, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

4 days

First QC Date

November 13, 2017

Last Update Submit

April 12, 2019

Conditions

Vital Sign Monitoring

Outcome Measures

Primary Outcomes (2)

  • Root-mean-square Deviation of Heart Rate

    Calculate the root-mean-square deviation (RMSD) of the heart rate using 20 pairs of valid and synchronously recorded heart rate of investigational device and patient monitor.

    30 days

  • Root-mean-square Deviation of Respiratory Rate

    Calculate the root-mean-square deviation (RMSD) of the respiratory rate using 20 pairs of valid and synchronously recorded respiratory rate of investigational device and patient monitor.

    30 days

Secondary Outcomes (4)

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

    30 days

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

    30 days

  • Motion Notification Accuracy(%)

    30 days

  • Bed Exit Notification Accuracy(%)

    30 days

Study Arms (2)

The Rhea Vital Sign Vigilance Device Group

EXPERIMENTAL

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

Device: The Rhea Vital Sign Vigilance Device Group

The Earlysense System Device Group

ACTIVE COMPARATOR

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

Device: The Earlysense System Device Group

Interventions

The Rhea Vital Sign Vigilance Device GroupDEVICE

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

The Rhea Vital Sign Vigilance Device Group
The Earlysense System Device GroupDEVICE

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.

The Earlysense System Device Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 23298-0102, United States

Location

Study Officials

  • Ava Puccio, RN

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: The RHEA device and Patient Monitor are used to monitor the heart rate (HR) and respiratory rate (RR) of participants at the same time in Test 1. The reference 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 the accuracy of the two devices. And the RHEA device is used alone to evaluate the accuracy of motion and no motion.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 29, 2017

Study Start

May 11, 2018

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)