NCT04003415

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2019-07-01
• Last updated: 2021-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study