COVID-19 and Lung Ultrasound Utility
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Device: Butterfly iQ
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Must be 18 years or older and able to provide a valid informed consent.
- Must have a nasal swab positive RT-PCR for COVID-19
- Must have access to Wi-Fi at home
Exclusion Criteria:
- Subjects unwilling or unable to directly provide consent.
- The following vulnerable study subject populations will not be eligible: prisoners, mentally impaired, or disadvantaged groups.
- Any condition deemed by the principal investigator, in his or her judgment, that may impact the subject's ability to meet the requirements necessary to collect the exam data required.
Sites / Locations
- Rocket Doctor Inc.
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
LUS ultrasound and standard of care
Arm Description
Subjects will perform a lung ultrasound in order to determine the ability of patients to take an ultrasound from their homes. The lung ultrasound will be coupled with telehealth clinical support to monitor the severity of COVID-19 patients and provide standard of care. All subjects will receive the lung ultrasound technology and daily calls for teleguidance through the ultrasound and standard of care to monitor symptoms.
Outcomes
Primary Outcome Measures
The efficacy of image-acquisition for patient-performed lung ultrasound as assessed by a standard Quality Assurance, including image quality, interpretation, and recommendations.
Patients will perform a lung ultrasound with teleguidance from a medical professional. This will be taken daily and monitored by an expert clinician who can guide based on the remote live transmission and probe position. The efficacy of the images obtained will be assessed using a standard Quality Assurance report using Soldati scoring which will be completed and synthesized following each appointment during the fourteen day period.
Secondary Outcome Measures
Correlate LUS radiographic findings with patient outcomes.
The LUS radiographic findings will be assessed to determine a possible correlation between the radiographic findings and disease timeline, clinical symptoms such as median oxygen saturation percentage readings, the number of ER visits, and the number hospital admissions. The score from a radiographic assessment will be compared to the course of a subject's illness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967729
Brief Title
COVID-19 and Lung Ultrasound Utility
Official Title
The Utility of Self-administered Lung Ultrasound in Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
June 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rocket Doctor Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ultrasounds are usually done by a specially trained health professional in the hospital or emergency department (ED) setting. Using a novel single-probe device, the ultrasound can be plugged into an iOS / Android device. The purpose of this research is to assess the usefulness of lung ultrasound imaging, performed by the patient in the home setting for the management of the COVID-19 disease using this novel highly-portable ultrasound.
Detailed Description
This will be a prospective self-controlled design. The study subjects will receive a telehealth visit from a healthcare provider (HCP) to assess for any change in their COVID-19 symptoms. The HCP will recommend the patient remain at home, or to go to an emergency department based on standard of care and clinical decision making. Subsequently, the study subjects will receive a teleguidance session with a Radiologist who is trained in lung ultrasound (LUS) in order to obtain images of their chest. The physician performing LUS remotely will report LUS findings in a standard quality assurance (QA) document, including image quality, interpretation, and recommendations. This QA report will be study data and not shared with the patient. The two providers will be blinded, except when there is a disagreement between the Telemed LUS and clinical interview.
The study staff will determine when this disagreement occurs. They will notify the study investigators and radiologist, who will then discuss and come to an agreement within 24 hours. If deemed concerning, they will then contact the HCP and unblind them as to the radiographic findings. There will be no delay in medical care advised by the subject's HCP.
Specifically, the nurse will inform the HCP by a phone call that the physician performing LUS remotely found a significant change in LUS findings. The HCP will then be given access to the LUS report (as well as images if desired), and will review the decision to seek medical care with the telemed doctor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LUS ultrasound and standard of care
Arm Type
Other
Arm Description
Subjects will perform a lung ultrasound in order to determine the ability of patients to take an ultrasound from their homes. The lung ultrasound will be coupled with telehealth clinical support to monitor the severity of COVID-19 patients and provide standard of care. All subjects will receive the lung ultrasound technology and daily calls for teleguidance through the ultrasound and standard of care to monitor symptoms.
Intervention Type
Device
Intervention Name(s)
Device: Butterfly iQ
Intervention Description
The Butterfly iQ is an ultrasound system that enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. It is a non-invasive device and does not impose any health hazards.
Primary Outcome Measure Information:
Title
The efficacy of image-acquisition for patient-performed lung ultrasound as assessed by a standard Quality Assurance, including image quality, interpretation, and recommendations.
Description
Patients will perform a lung ultrasound with teleguidance from a medical professional. This will be taken daily and monitored by an expert clinician who can guide based on the remote live transmission and probe position. The efficacy of the images obtained will be assessed using a standard Quality Assurance report using Soldati scoring which will be completed and synthesized following each appointment during the fourteen day period.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Correlate LUS radiographic findings with patient outcomes.
Description
The LUS radiographic findings will be assessed to determine a possible correlation between the radiographic findings and disease timeline, clinical symptoms such as median oxygen saturation percentage readings, the number of ER visits, and the number hospital admissions. The score from a radiographic assessment will be compared to the course of a subject's illness.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be 18 years or older and able to provide a valid informed consent.
Must have a nasal swab positive RT-PCR for COVID-19
Must have access to Wi-Fi at home
Exclusion Criteria:
Subjects unwilling or unable to directly provide consent.
The following vulnerable study subject populations will not be eligible: prisoners, mentally impaired, or disadvantaged groups.
Any condition deemed by the principal investigator, in his or her judgment, that may impact the subject's ability to meet the requirements necessary to collect the exam data required.
Facility Information:
Facility Name
Rocket Doctor Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
COVID-19 and Lung Ultrasound Utility
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