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

Olive View-UCLA Education & Research Institute

Status: Unknown

Conditions: Lung Injury; Acute Respiratory Distress Syndrome; Covid19; ARDS; Hypoxemia; Ultrasound; Acute Cardiac Event

Treatments: Diagnostic Test: Point of Care Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05228717

1590419

Details and patient eligibility

About

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).

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

240 participants in 1 patient group

COVID+

Description:

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

Treatment:

Diagnostic Test: Point of Care Ultrasound