Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

Summary

This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. We propose to study whether the device's measurements are accurate and reproducible in patients with chronic obstructive pulmonary disease (COPD) or asthma. The device undergoing study has been evaluated in healthy volunteers, but its accuracy in vital sign monitoring in patients with respiratory conditions has not yet been established. This study will serve as the foundation for additional work to assess the device's accuracy in measuring a patient's overall "work of breathing" or respiratory effort. Future work will examine the device's accuracy in measuring work of breathing in patients having an exacerbation of their underlying respiratory condition.

The primary aim of this study will be to assess the validity of heart rate and respiratory rate measurements in patients with either COPD or asthma.

Conditions

• Copd
• Asthma
• Respiratory Effort
• Contactless Vital Sign Monitoring

Interventions

DEVICE

Investigational Device: Contactless heart rate and respiratory rate monitor

Participant will be seated next to the investigational device. The device is contactless, and will measure the patient's heart rate and respiratory rate through use of radio-waves.

DIAGNOSTIC_TEST

Heart Rate (EKG) Monitor

Participant will undergo 3-lead EKG testing to measure heart rate during testing.

DIAGNOSTIC_TEST

Respiratory rate Monitor

Participant will have an elastic band around their chest for monitoring respiratory rate during testing.

DIAGNOSTIC_TEST

Pulse Oximetry

Participants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry.

Sponsors & Collaborators

• Work of Breathing Study Group

  collaborator UNKNOWN

• Stanford University

  lead OTHER

Principal Investigators

• Andrea Jonas · Stanford University

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-01

Primary Completion

2021-09-20

Completion

2021-09-20

FDA Device

Yes

Countries

• United States

Study Locations