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

Covid19 Clinical Trial

— PIOS-COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228717
• Other study ID #: 1590419
• Status: Recruiting
• Start date: November 10, 2020
• Est. completion date: June 2022

Study information

• Verified date: April 2022
• Source: Olive View-UCLA Education & Research Institute
• Contact: James Murphy, MD
• Phone: 7472103107
• Email: jjmurphy[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cardiac Event
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS
• COVID-19
• Covid19
• Hypoxemia
• Hypoxia
• Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Ultrasound

Intervention

Diagnostic Test:
• Point of Care Ultrasound
q48-72h point of care ultrasound of the lungs, heart, and IVC (inferior vena cava)

Locations

Country	Name	City	State
United States	UCLA-Ronald Reagan	Los Angeles	California
United States	SUNY Downstate	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	Olive View-UCLA	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
Olive View-UCLA Education & Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. — View Citation

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Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From admission to 21 days, or endpoint reached
Primary	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.	From admission to 21 days, or endpoint reached
Secondary	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.	From admission to 21 days, or endpoint reached
Secondary	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.	From admission to 21 days, or endpoint reached