Predicting Outcomes for Covid-19 Using Sonography

COVID-19 Clinical Trial

— POCUS  

Official title:

Predicting Outcomes for Covid-19 Using Sonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384055
• Other study ID #: IRB-55621
• Status: Completed
• Start date: March 21, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: December 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pneumonia, Viral

Intervention

Diagnostic Test:
• Lung Ultrasound
Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula	Composite primary outcome of death, ICU admission, mechanical ventilation, or use of high-flow nasal cannula (categorical)	28 days from initial evaluation
Secondary	Number of Patients Requiring Mechanical Ventilation		28 days from initial evaluation
Secondary	Number of Patients Requiring Supplemental Oxygen Usage		28 days from initial evaluation
Secondary	Duration of Supplemental Oxygen Usage		28 days from initial evaluation
Secondary	Length of Stay	Duration of Hospitalization (days)	28 days from initial evaluation
Secondary	Characterization of Ultrasound Findings	Descriptive analysis of ultrasound findings in Covid-19	28 days from initial evaluation