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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003415
• Other study ID #: IRB-51805
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient seen at the Stanford University Hospital Chest Clinic
• Patient age 18 or older
• Patient able to consent
• Patient with one of the following two medical conditions: Chronic Obstructive Pulmonary - Disease or Asthma
• Participant (or accompanying family / caretaker) able to speak English

Exclusion Criteria:

• Patient does not meet inclusion criteria (under age 18, unable to consent, etc.)
• Patient is hospitalized
• Patient is having an acute exacerbation of their respiratory condition
• Patient is having an acute exacerbation of a comorbid condition
• Patient has comorbid cardiac disease, including one of the conditions listed below:
• Arrhythmias (including atrial fibrillation, NSVT, etc.)
• Congestive Heart Failure
• Unstable angina
• Myocardial infarction within the last 3 months prior to enrollment
• Uncorrected congenital heart disease
• Uncorrected severe valvular disease
• Pulmonary Hypertension (moderate or higher grade)
• Patient has one of the following conditions:
• Moderate pleural effusion
• Large pleural effusion
• Advanced stage lung cancer (Stage III or Stage IV disease)
• Active infectious process, including viral process or pneumonia
• Interstitial lung disease
• Pleural disease, including pleural malignancies, trapped lung, etc
• Active Cheyne-Stokes respiration
• Patient has baseline increased work of breathing not due to their underlying respiratory disease (ie. COPD or asthma)
• Ongoing substance abuse (not including cigarette use)

Related Conditions & MeSH terms

• Asthma
• Contactless Vital Sign Monitoring
• Copd
• Respiration Disorders
• Respiratory Effort
• Respiratory Tract Diseases

Intervention

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.
• Respiratory rate Monitor
Participant will have an elastic band around their chest for monitoring respiratory rate during testing.
• Pulse Oximetry
Participants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Work of Breathing Study Group

Country where clinical trial is conducted

United States, 

References & Publications (2)

Levitas, I. Naidionova and J. Matuzas,

Li W, Tan B, Piechocki R. Passive Radar for Opportunistic Monitoring in E-Health Applications. IEEE J Transl Eng Health Med. 2018 Jan 25;6:2800210. doi: 10.1109/JTEHM.2018.2791609. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.	30 - 60 minutes
Primary	Respiratory rate	Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.	30 - 60 minutes

External Links

•   Reference 1
•   Reference 2