Loading clinical trials...
Loading clinical trials...
Point-of-care Lung Ultrasound (POCUS)-Integrated Observation Study of Admitted Patients With COVID-19
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).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCLA-Ronald Reagan
Los Angeles, California, United States
Olive View-UCLA
Sylmar, California, United States
SUNY Downstate
New York, New York, United States
Temple University
Philadelphia, Pennsylvania, United States
Start Date
November 10, 2020
Primary Completion Date
June 1, 2022
Completion Date
June 1, 2022
Last Updated
April 29, 2022
240
ESTIMATED participants
Point of Care Ultrasound
DIAGNOSTIC_TEST
Lead Sponsor
Olive View-UCLA Education & Research Institute
NCT07414056
NCT04485286
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06701669