Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19

Respiratory Failure Clinical Trial

— CLUSCO  

Official title:

Prognostic Value of Point of Care Cardiac and Lung Ultrasound in COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379544
• Other study ID #: 843008
• Status: Completed
• Start date: April 23, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a protocol-driven observational study of lung ultrasound and focused echocardiography images obtained in the Emergency Department (ED) and Intensive Care Unit (ICU) settings as a part of existing standard of care. The objectives of this study are as follows:

1. To characterize various clinical and cardiopulmonary ultrasound findings and describe their relationship with the clinical course of patients with COVID-19 in the ED and ICU.

2. To describe, develop, and validate a prediction tool that can accurately predict the need for invasive mechanical ventilation (IMV) and acute respiratory failure in COVID-19 patients using clinical, laboratory, and ultrasound data.

Description:

Background and scientific rationale:

During the COVID-19 pandemic, health care systems around the world are overwhelmed.

Surge of patients requiring hospital admission have led to shortages of ICU beds and mechanical ventilators. As an emerging clinical entity, little is known about the precise pathophysiologic mechanisms of COVID-19. Recent observational data and clinical experience has suggested that there could be different phenotypes of patients with COVID-19 which could explain the wide range of clinical presentations, response to therapies and outcomes.

Point of care cardiac and lung ultrasound (CLUS) has been proposed as a tool with potential to assist diagnostic evaluation and management of COVID-19 patients in the emergency department (ED) and intensive care unit (ICU) settings. Point of care CLUS is routinely used as part of the clinical evaluation of patients with dyspnea, hypoxemia, chest pain and shock in the ED and ICU. Patients with COVID-19 commonly present to the ED with these symptoms and therefore CLUS is being commonly used in patients with suspected or confirmed diagnosis of COVID-19.

Small observational studies have described several lung ultrasound (LUS) findings in patients with COVID-19. These findings include; pleural irregularity ("thickening"), subpleural consolidations, air bronchogram, isolated B-lines, fused B-lines and pleural effusions. Other observational studies have described the presence of acute myocardial abnormalities in patients with COVID-19 seen in echocardiography, including left and right ventricular systolic dysfunction.

Multiple studies have described and validated the finding of B-lines in LUS as a non-invasive marker of extravascular lung water. B-lines in LUS correlate with pulmonary capillary wedge pressures, NT-proBNP and E/e' and has been validated as a reliable prognostic factor in patients with decompensated heart failure. B-lines are also found in other pulmonary processes including viral pneumonia, ARDS, pulmonary contusions and post radiation changes. Observational studies involving COVID-19 patients have shown the presence of isolated and fused or continuous B-lines in the pneumonia associated with this infection. We hypothesize that the presence of B-lines in LUS may be marker of severity, and that alone or in concert with other clinical or laboratory variables, could help predict the clinical course and prognosis of COVID-19 patients.

Knowledge gaps

1. Does point of care cardiopulmonary ultrasound findings alone, or combined with other clinical and/or laboratory variables, predict clinical outcomes of patients with COVID-19?

2. Can different lung ultrasound finding patterns correlate with clinical severity or outcomes?

Specific aims

1. To characterize various clinical and CLUS findings and describe their relationship with clinical course of patients with COVID-19 in ED and ICU.

2. Using clinical, laboratory and ultrasound data to describe, develop and validate a prediction tool that can accurately predict (1) need of invasive mechanical ventilation (IVM) and (2) acute respiratory failure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• COVID-19 positive or suspected positive

• Received a cardiopulmonary ultrasound scan

Exclusion Criteria:

• Did not receive a scan

• Not COVID-19 positive

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Observation only
There is no intervention. This study is purely observational. This study simply follows COVID-19 patients who get CPUS based on their clinician deeming it necessary.

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (15)

Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326. — View Citation

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. — View Citation

Danzi GB, Loffi M, Galeazzi G, Gherbesi E. Acute pulmonary embolism and COVID-19 pneumonia: a random association? Eur Heart J. 2020 May 14;41(19):1858. doi: 10.1093/eurheartj/ehaa254. No abstract available. — View Citation

Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available. — View Citation

Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28. — View Citation

Hendren NS, Drazner MH, Bozkurt B, Cooper LT Jr. Description and Proposed Management of the Acute COVID-19 Cardiovascular Syndrome. Circulation. 2020 Jun 9;141(23):1903-1914. doi: 10.1161/CIRCULATIONAHA.120.047349. Epub 2020 Apr 16. — View Citation

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;: — View Citation

Long B, Brady WJ, Koyfman A, Gottlieb M. Cardiovascular complications in COVID-19. Am J Emerg Med. 2020 Jul;38(7):1504-1507. doi: 10.1016/j.ajem.2020.04.048. Epub 2020 Apr 18. — View Citation

Mitchell C, Collins K, Hua L, McClanahan C, Shea E, Umland M, Wasserman M. Specific Considerations for Sonographers When Performing Echocardiography during the 2019 Novel Coronavirus Outbreak: Supplement to the American Society of Echocardiography Statement. J Am Soc Echocardiogr. 2020 Jun;33(6):654-657. doi: 10.1016/j.echo.2020.04.014. Epub 2020 Apr 11. — View Citation

Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13. — View Citation

Spencer KT, Kimura BJ, Korcarz CE, Pellikka PA, Rahko PS, Siegel RJ. Focused cardiac ultrasound: recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2013 Jun;26(6):567-81. doi: 10.1016/j.echo.2013.04.001. No abstract available. — View Citation

Vieillard-Baron A, Price LC, Matthay MA. Acute cor pulmonale in ARDS. Intensive Care Med. 2013 Oct;39(10):1836-8. doi: 10.1007/s00134-013-3045-2. Epub 2013 Aug 2. No abstract available. — View Citation

Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113. — View Citation

Xie Y, Wang X, Yang P, Zhang S. COVID-19 Complicated by Acute Pulmonary Embolism. Radiol Cardiothorac Imaging. 2020 Mar 16;2(2):e200067. doi: 10.1148/ryct.2020200067. eCollection 2020 Apr. No abstract available. — View Citation

Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient requires invasive mechanical ventilation and suffers from acute respiratory failure.	Number of patients requiring invasive mechanical ventilation and suffers from acute respiratory failure.	1 Year
Primary	Patient is discharged	Number of patients that do not require hospitalization and is able to safely recover from COVID-19 at home.	1 Year
Primary	Patient is hospitalized, but does not require mechanical ventilation through the duration of hospital stay.	Number of patients that must be hospitalized to recover from COVID-19, but does not require invasive mechanical ventilation and may or may not suffer from some degree of acute respiratory failure.	1 Year
Secondary	Lung ultrasound findings	Any lung ultrasound findings including, but not limited to b-lines, a-lines, consolidations, pleural effusions and regularities. All of these findings are consolidated to a single score which will be the measure of the severity of lung ultrasound findings.	1 year
Secondary	Cardiac ultrasound findings	Any cardiac ultrasound findings including, but not limited to IVC status, pericardial effusions, LV EF (%), RV function. All of these findings are consolidated to a single score which will be the measure of the severity of cardiac ultrasound findings.	1 year

External Links

•   Study information site