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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05228717
Acronym
PIOS-COVID
Enrollment
240
Registered
2022-02-08
Start date
2020-11-10
Completion date
2022-06-30
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cardiac Event, Acute Respiratory Distress Syndrome, ARDS, Covid19, Hypoxemia, Lung Injury, Ultrasound

Brief 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).

Detailed 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.

Interventions

DIAGNOSTIC_TESTPoint of Care Ultrasound

q48-72h point of care ultrasound of the lungs, heart, and IVC (inferior vena cava)

Sponsors

Olive View-UCLA Education & Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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 next of kin give consent for participation.

Exclusion criteria

* age \< 18 years old, pregnant patients, or patients that verbally refuse participation

Design outcomes

Primary

MeasureTime frameDescription
Association of POCUS changes with major clinical eventsFrom admission to 21 days, or endpoint reachedAssociation 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 from POCUS worsening to clinical diagnosis.From admission to 21 days, or endpoint reachedTime 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.

Secondary

MeasureTime frameDescription
Utilization of traditional radiographyFrom admission to 21 days, or endpoint reachedTo assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.
Individual clinical outcomesFrom admission to 21 days, or endpoint reachedInvestigators 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.

Countries

United States

Contacts

Primary ContactJames Murphy, MD
jjmurphy@mednet.ucla.edu7472103107
Backup ContactAlan Chiem, MD
achiem@mednet.ucla.edu7472103107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026