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

Sponsor

Olive View-UCLA Education & Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05228717

Collaborator

(none)

240

Enrollment

Locations

18.7

Anticipated Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Injury ARDS Acute Cardiac Event Covid19 Ultrasound Hypoxemia Acute Respiratory Distress Syndrome	Diagnostic Test: Point of Care Ultrasound

Detailed Description

SPECIFIC AIMS

To define the lung ultrasound profile of patients admitted with COVID-19 pneumonia, hypoxia, or hypoxemic respiratory failure.
To document the progression of POCUS findings in admitted patients with COVID-19 respiratory failure.
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:

To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.
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.
To assess the prevalence of lung ultrasound findings suggestive of COVID-19 infection in patients that present with acute coronary syndromes.

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 10, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
COVID+ 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)

Arm

Intervention/Treatment

COVID+

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)

Outcome Measures

Primary Outcome Measures

Association of POCUS changes with major clinical events [From admission to 21 days, or endpoint reached]
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 from POCUS worsening to clinical diagnosis. [From admission to 21 days, or endpoint reached]
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.

Secondary Outcome Measures

Utilization of traditional radiography [From admission to 21 days, or endpoint reached]
To assess the potential change of using POCUS in CT and plain film utilization, as well as emergency department and inpatient LOS.
Individual clinical outcomes [From admission to 21 days, or endpoint reached]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA-Ronald Reagan	Los Angeles	California	United States	90095
2	Olive View-UCLA	Sylmar	California	United States	91342
3	SUNY Downstate	New York	New York	United States	11203
4	Temple University	Philadelphia	Pennsylvania	United States	19140