Clinical trial NCT04384055: Predicting Outcomes for Covid-19 Using Sonography
Official title: Predicting Outcomes for Covid-19 Using Sonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Pneumonia, Viral
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Any adult (18 or more years of age) presenting to the emergency department with symptoms suspicious for Covid-19
* This individual underwent evaluation for Covid-19 via a nasopharyngeal RT-PCR
* This individual received a lung ultrasound by the study authors within 28 days from initial evaluation

Exclusion Criteria:

* Any individual who did not receive a lung ultrasound within 28 days from initial evaluation for covid-19 related illness

Primary outcomes:
measure: Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula
timeFrame: 28 days from initial evaluation
Secondary outcomes:
measure: Number of Patients Requiring Mechanical Ventilation
timeFrame: 28 days from initial evaluation
measure: Number of Patients Requiring Supplemental Oxygen Usage
timeFrame: 28 days from initial evaluation
measure: Duration of Supplemental Oxygen Usage
timeFrame: 28 days from initial evaluation
measure: Length of Stay
timeFrame: 28 days from initial evaluation
measure: Characterization of Ultrasound Findings
timeFrame: 28 days from initial evaluation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andre D Kumar, MD, MEd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Sally Graglia, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: