An observational study in Lung Injury, ARDS and Acute Cardiac Event, sponsored by Olive View-UCLA Education & Research Institute. Status unknown at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Olive View-UCLA Education & Research Institute · Observational
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
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:
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:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 240 is close to the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Olive View-UCLA Education & Research Institute is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inpatients with COVID-19 Pneumonia/hypoxemic respiratory failure requiring at least 3L of O2.
Exclusion Criteria:
Patients with confirmed COVID-19 pneumonia as the primary diagnosis, or COVID-associated acute hypoxemic respiratory failure or hypoxia (minimum O2 requirement 3L), that are being admitted from the emergency department, who either have waiver of consent, give verbal consent to participate, or have NOK (next of kin) provide consent. Exclusion criteria: age \<18 years old, pregnant patients, or patients that verbally refuse participation Intervention/observation: q48-72h POCUS of the lungs, heart, and IVC
Diagnostic Test: Point of Care Ultrasound
q48-72h point of care ultrasound of the lungs, heart, and IVC (inferior vena cava)
Association of POCUS changes with major clinical events
Association of POCUS worsening with development of a composite outcome of development of ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, pneumothorax, cardiac tamponade, or death.
Time frame: From admission to 21 days, or endpoint reached
Time from POCUS worsening to clinical diagnosis.
Time interval from POCUS worsening to clinical diagnosis. Investigators will measure the duration between POCUS worsening and clinical diagnosis of any of the major clinical events described in outcome 1.
Time frame: From admission to 21 days, or endpoint reached
Utilization of traditional radiography
To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.
Time frame: From admission to 21 days, or endpoint reached
Individual clinical outcomes
Investigators will compare POCUS changes and the time interval to development of each of the following outcomes: ARDS, acute cardiac injury, hypoxemic respiratory failure requiring prone positioning or ECMO, pneumothorax, cardiac tamponade, or death.
Time frame: From admission to 21 days, or endpoint reached
Plan to share: Undecided
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Olive View-UCLA Education & Research Institute