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

Not Applicable

Completed

• Conditions: Copd; Contactless Vital Sign Monitoring; Asthma; Respiratory Effort
• Interventions: Diagnostic Test: Heart Rate (EKG) Monitor; Diagnostic Test: Respiratory rate Monitor; Diagnostic Test: Pulse Oximetry

• Registration Number: NCT04003415
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-07-01
• Study Start: 2020-03-01
• Status Verified: 2021-09
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Device Arm	Respiratory rate Monitor	Once consented for the study, participants will undergo testing with the investigational device for a one hour period. Testing will entail the participant wearing an EKG monitor, a respiratory rate monitor, a pulse oximeter, and being positioned next to the investigational device. The investigational device is contactless and captures chest movement of participants which allows it to estimate real time heart rate and respiratory rate. Additional data collected with the EKG monitor, respiratory rate monitor, and the pulse oximeter will be used to validate the vital sign data collected by the investigational device. After data collection is complete, participant involvement will then be over. Participants will have the option to return on a later date for additional testing (up to a maximum of three sessions total), within the six month window of the study. Participants will continue their standard of care therapies for their respiratory condition.
Investigational Device Arm	Heart Rate (EKG) Monitor	Once consented for the study, participants will undergo testing with the investigational device for a one hour period. Testing will entail the participant wearing an EKG monitor, a respiratory rate monitor, a pulse oximeter, and being positioned next to the investigational device. The investigational device is contactless and captures chest movement of participants which allows it to estimate real time heart rate and respiratory rate. Additional data collected with the EKG monitor, respiratory rate monitor, and the pulse oximeter will be used to validate the vital sign data collected by the investigational device. After data collection is complete, participant involvement will then be over. Participants will have the option to return on a later date for additional testing (up to a maximum of three sessions total), within the six month window of the study. Participants will continue their standard of care therapies for their respiratory condition.
Investigational Device Arm	Pulse Oximetry	Once consented for the study, participants will undergo testing with the investigational device for a one hour period. Testing will entail the participant wearing an EKG monitor, a respiratory rate monitor, a pulse oximeter, and being positioned next to the investigational device. The investigational device is contactless and captures chest movement of participants which allows it to estimate real time heart rate and respiratory rate. Additional data collected with the EKG monitor, respiratory rate monitor, and the pulse oximeter will be used to validate the vital sign data collected by the investigational device. After data collection is complete, participant involvement will then be over. Participants will have the option to return on a later date for additional testing (up to a maximum of three sessions total), within the six month window of the study. Participants will continue their standard of care therapies for their respiratory condition.

Primary Outcome Measures

Name	Time	Method
Heart Rate	30 - 60 minutes	Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.
Respiratory rate	30 - 60 minutes	Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States