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Completed

NCT Number: NCT04003415

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Investigational Device: Contactless heart rate and respiratory rate monitor

Device

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.

Other names: Investigational Device

Heart Rate (EKG) Monitor

Diagnostic Test

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

Respiratory rate Monitor

Diagnostic Test

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

Pulse Oximetry

Diagnostic Test

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

Primary outcomes

  1. Heart Rate

    Time frame: 30 - 60 minutes

    Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.

  2. Respiratory rate

    Time frame: 30 - 60 minutes

    Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Work of Breathing Study Group

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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