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出境医 / 临床实验 / Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients

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

Study Description
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.


Condition or disease Intervention/treatment Phase
Copd Asthma Respiratory Effort Contactless Vital Sign Monitoring Device: Investigational Device: Contactless heart rate and respiratory rate monitor Diagnostic Test: Heart Rate (EKG) Monitor Diagnostic Test: Respiratory rate Monitor Diagnostic Test: Pulse Oximetry Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants enrolled in the study will be in the intervention arm. Intervention consists of device feasibility and validation of heart rate and respiratory rate data collected.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Investigational Device Arm
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.
 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.
Other Name: Investigational Device

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.
Outcome Measures
Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Contacts
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Contact: Andrea Principal Investigator 650 725 7061 amjonas@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University
Palo Alto, California, United States, 94304
Contact: Andrea Jonas, MD    650-725-7061    amjonas@stanford.edu   
Sponsors and Collaborators
Stanford University
Work of Breathing Study Group
Investigators
Layout table for investigator information
Principal Investigator: Andrea Jonas Stanford University
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date July 1, 2019
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Heart Rate [ Time Frame: 30 - 60 minutes ]
    Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.
  • Respiratory rate [ Time Frame: 30 - 60 minutes ]
    Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients
Official Title  ICMJE Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All participants enrolled in the study will be in the intervention arm. Intervention consists of device feasibility and validation of heart rate and respiratory rate data collected.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Copd
  • Asthma
  • Respiratory Effort
  • Contactless Vital Sign Monitoring
Intervention  ICMJE
  • 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.
    Other Name: Investigational Device
  • 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.
Study Arms  ICMJE Experimental: Investigational Device Arm
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.
Interventions:
  • Device: Investigational Device: Contactless heart rate and respiratory rate monitor
  • Diagnostic Test: Heart Rate (EKG) Monitor
  • Diagnostic Test: Respiratory rate Monitor
  • Diagnostic Test: Pulse Oximetry
Publications *
  • 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.
  • Levitas, I. Naidionova and J. Matuzas,

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003415
Other Study ID Numbers  ICMJE IRB-51805
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (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.
Responsible Party Andrea Jonas, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Work of Breathing Study Group
Investigators  ICMJE
Principal Investigator: Andrea Jonas Stanford University
PRS Account Stanford University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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