Predicting Outcomes for Covid-19 Using Sonography (POCUS)
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ClinicalTrials.gov Identifier: NCT04384055 |
Recruitment Status :
Completed
First Posted : May 12, 2020
Last Update Posted : December 3, 2021
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Tracking Information | |||||||
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First Submitted Date | May 8, 2020 | ||||||
First Posted Date | May 12, 2020 | ||||||
Last Update Posted Date | December 3, 2021 | ||||||
Actual Study Start Date | March 21, 2020 | ||||||
Actual Primary Completion Date | November 15, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula [ Time Frame: 28 days from initial evaluation ] Composite primary outcome of death, ICU admission, mechanical ventilation, or use of high-flow nasal cannula (categorical)
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Predicting Outcomes for Covid-19 Using Sonography | ||||||
Official Title | Predicting Outcomes for Covid-19 Using Sonography | ||||||
Brief Summary | This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify Covid-19 pneumonia or patients at risk for deterioration early in the disease course. | ||||||
Detailed Description | As Covid-19 continues to stress hospital-based resources (including personal protective equipment, ancillary staff availability, and imaging study utilization), it is important to assess whether alternative methods for evaluating patients can be utilized to appropriately triage and care for Covid-positive patients. Current limitations of caring for patients with Covid-19 include the exposure of ancillary healthcare workers (including radiological technicians) and the time/resources required to decontaminate traditional radiological equipment such as x-ray or computerized tomography (CT) machines. Point-of-care ultrasound (POCUS) has the potential to transform healthcare delivery due to its diagnostic and therapeutic expediency. It can be quickly performed at the bedside by experienced clinicians. It it has been shown to reliably and accurately diagnose patients with a variety of lung diseases, including pneumonia. This study seeks to investigate the role of lung ultrasound in caring for Covid-19 positive patients and whether it can be used to predict patient deterioration. This information will be vital for healthcare workers who seek to identify the virus or patients at risk for deterioration early in the disease course. Moreover, it has the potential to reduce the need for x-rays or CTs for Covid-19 patients, which has the potential to alleviate a significant burden currently being placed on the healthcare system. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | This population will include all persons under investigation (PUIs) for covid-19 presenting to the Stanford emergency department. | ||||||
Condition |
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Intervention | Diagnostic Test: Lung Ultrasound
Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
165 | ||||||
Original Estimated Enrollment |
200 | ||||||
Actual Study Completion Date | November 15, 2021 | ||||||
Actual Primary Completion Date | November 15, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT04384055 | ||||||
Other Study ID Numbers | IRB-55621 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Stanford University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | Stanford University | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Stanford University | ||||||
Verification Date | December 2021 |