Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2021
CompletedSeptember 28, 2021
September 1, 2021
1.6 years
June 26, 2019
September 22, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Heart Rate
Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.
30 - 60 minutes
Respiratory rate
Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.
30 - 60 minutes
Study Arms (1)
Investigational Device Arm
EXPERIMENTALOnce 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.
Interventions
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.
Participant will undergo 3-lead EKG testing to measure heart rate during testing.
Participant will have an elastic band around their chest for monitoring respiratory rate during testing.
Participants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Work of Breathing Study Groupcollaborator
Study Sites (1)
Stanford University
Palo Alto, California, 94304, United States
Related Publications (2)
W. Li, B. Tan and R. J. Piechocki,
BACKGROUNDLevitas, I. Naidionova and J. Matuzas,
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Jonas
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pulmonary & Critical Care Fellow
Study Record Dates
First Submitted
June 26, 2019
First Posted
July 1, 2019
Study Start
March 1, 2020
Primary Completion
September 20, 2021
Study Completion
September 20, 2021
Last Updated
September 28, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data collection will take place over the course of a 6 month period. De-identified patient data will be kept for a period of 5 years.
- Access Criteria
- Access to patient PHI will be limited to the study PI and the faculty sponsor. Access to de-identified patient data will be allowed for research and industry collaborators for analysis.
Full Access: Access to Data, Access to patient PHI, Access to RedCap Document linking patients to their study numbers. Limited Access: Access to de-identified participant data for analysis Study PI and Study Faculty Sponsor: Full Access Research Team and Industry Sponsors: Limited Access Upon enrollment each participant will be assigned a unique study number. Any study data collected will be linked to the patient solely through the study number. The document that contains the patient information and their study numbers will by kept on Stanford RedCap and will only be accessible by the study PI and the faculty sponsor. De-identified data of vital sign measurements will be shared between the Stanford research team and industry collaborators. Data will be downloaded to an encrypted USB key and hand-delivered between members of the research team. For smaller files, de-identified patient data will be mailed securely between the research team members.