Point-of-care Lung Ultrasound (POCUS)-Integrated Study of Admitted Patients With COVID-19 — PIOS-COVID  

Covid19 Clinical Trial

Official title: Point-of-care Lung Ultrasound (POCUS)-Integrated Observation Study of Admitted Patients With COVID-19

Status Recruiting

Clinical Trial Summary

This study seeks to define the ultrasound profile of patients with COVID-19, and document the progression of these ultrasound findings to develop prognostication and clinical decision instruments that can help guide management of patient with COVID-19. Primary aims include the development of ARDS, refractory hypoxemia, acute cardiac injury, pulmonary embolism, pneumothorax or death. Secondary aims include potential change in CT and plain film utilization given the use of POCUS, as well as emergency department and inpatient LOS (length of stay).

Clinical Trial Description

A. SPECIFIC AIMS

1. To define the lung ultrasound profile of patients admitted with COVID-19 pneumonia, hypoxia, or hypoxemic respiratory failure.

2. To document the progression of POCUS findings in admitted patients with COVID-19 respiratory failure.

3. Along with other clinical data, to develop a prognostication and clinical decision instrument that can help guide management of patients with COVID-19, specifically for the following specific outcomes:

• Development of ARDS, worsening oxygen requirement, or need for intubation. On POCUS, this would be associated with a shift in lateral lung involvement to anterior lung zone involvement; or overall increase in B-lines for all lung zones

• Refractory hypoxemia requiring lung recruitment maneuvers, including prone positioning or ECMO (extra-corporeal membrane oxygenation). On POCUS, this would be associated with the presence of posterior-lateral alveolar consolidation, which gives the appearance of "hepatization of lung"

• Development of acute cardiac injury, as defined by acute coronary syndrome or myocarditis. On POCUS, this would be associated with the development of worsening systolic function

• Development of pulmonary embolism as defined by CT evidence, +DVT (deep vein thrombosis), or therapeutic anticoagulation. On POCUS, this would be associated with a RV (right ventricle) strain pattern (D-shaped septum on parasternal short axis, RV>LV (left ventricle) diameter on apical)

• Development of pneumothorax. On POCUS, this would be associated with the absence of pleural sliding

A composite outcome of development of ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, PE (pulmonary embolism), PTX (pneumothorax), or death, will be used as the primary outcome.

These are secondary aims that investigators will assess, but not base our power calculation on:

4. To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.

5. If current triage workflow related to the COVID-19 pandemic integrates POCUS into triage, investigators will extend this analysis to the point of triage, and not just admitted patients.

6. To assess the prevalence of lung ultrasound findings suggestive of COVID-19 infection in patients that present with acute coronary syndromes. ;

Related Conditions & MeSH terms

• Acute Cardiac Event
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS
• COVID-19
• Covid19
• Hypoxemia
• Hypoxia
• Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Ultrasound

• NCT number: NCT05228717
• Study type: Observational
• Source: Olive View-UCLA Education & Research Institute
• Contact: James Murphy, MD
• Phone: 7472103107
• Email: jjmurphy@mednet.ucla.edu
• Status: Recruiting
• Start date: November 10, 2020
• Completion date: June 2022