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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05228717
Other study ID # 1590419
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)

Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26. — View Citation

Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17. — View Citation

Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. — View Citation

Chavez MA, Shams N, Ellington LE, Naithani N, Gilman RH, Steinhoff MC, Santosham M, Black RE, Price C, Gross M, Checkley W. Lung ultrasound for the diagnosis of pneumonia in adults: a systematic review and meta-analysis. Respir Res. 2014 Apr 23;15:50. doi: 10.1186/1465-9921-15-50. Review. — View Citation

Cheng Z, Lu Y, Cao Q, Qin L, Pan Z, Yan F, Yang W. Clinical Features and Chest CT Manifestations of Coronavirus Disease 2019 (COVID-19) in a Single-Center Study in Shanghai, China. AJR Am J Roentgenol. 2020 Jul;215(1):121-126. doi: 10.2214/AJR.20.22959. Epub 2020 Mar 14. — View Citation

Chung M, Bernheim A, Mei X, Zhang N, Huang M, Zeng X, Cui J, Xu W, Yang Y, Fayad ZA, Jacobi A, Li K, Li S, Shan H. CT Imaging Features of 2019 Novel Coronavirus (2019-nCoV). Radiology. 2020 Apr;295(1):202-207. doi: 10.1148/radiol.2020200230. Epub 2020 Feb 4. — View Citation

Clerkin KJ, Fried JA, Raikhelkar J, Sayer G, Griffin JM, Masoumi A, Jain SS, Burkhoff D, Kumaraiah D, Rabbani L, Schwartz A, Uriel N. COVID-19 and Cardiovascular Disease. Circulation. 2020 May 19;141(20):1648-1655. doi: 10.1161/CIRCULATIONAHA.120.046941. Epub 2020 Mar 21. Review. — View Citation

Copetti R, Soldati G, Copetti P. Chest sonography: a useful tool to differentiate acute cardiogenic pulmonary edema from acute respiratory distress syndrome. Cardiovasc Ultrasound. 2008 Apr 29;6:16. doi: 10.1186/1476-7120-6-16. — View Citation

Dietrich CF, Mathis G, Cui XW, Ignee A, Hocke M, Hirche TO. Ultrasound of the pleurae and lungs. Ultrasound Med Biol. 2015 Feb;41(2):351-65. doi: 10.1016/j.ultrasmedbio.2014.10.002. Review. — 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

Hasan AA, Makhlouf HA. B-lines: Transthoracic chest ultrasound signs useful in assessment of interstitial lung diseases. Ann Thorac Med. 2014 Apr;9(2):99-103. doi: 10.4103/1817-1737.128856. — View Citation

Henderson WR, Griesdale DE, Dominelli P, Ronco JJ. Does prone positioning improve oxygenation and reduce mortality in patients with acute respiratory distress syndrome? Can Respir J. 2014 Jul-Aug;21(4):213-5. Epub 2014 Jun 13. Review. — View Citation

Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. — View Citation

Lichtenstein DA, Lascols N, Mezière G, Gepner A. Ultrasound diagnosis of alveolar consolidation in the critically ill. Intensive Care Med. 2004 Feb;30(2):276-281. doi: 10.1007/s00134-003-2075-6. Epub 2004 Jan 13. — View Citation

Mayo PH, Beaulieu Y, Doelken P, Feller-Kopman D, Harrod C, Kaplan A, Oropello J, Vieillard-Baron A, Axler O, Lichtenstein D, Maury E, Slama M, Vignon P. American College of Chest Physicians/La Société de Réanimation de Langue Française statement on competence in critical care ultrasonography. Chest. 2009 Apr;135(4):1050-1060. doi: 10.1378/chest.08-2305. Epub 2009 Feb 2. — View Citation

Mayo PH, Copetti R, Feller-Kopman D, Mathis G, Maury E, Mongodi S, Mojoli F, Volpicelli G, Zanobetti M. Thoracic ultrasonography: a narrative review. Intensive Care Med. 2019 Sep;45(9):1200-1211. doi: 10.1007/s00134-019-05725-8. Epub 2019 Aug 15. Review. — View Citation

Pan F, Ye T, Sun P, et al. Time Course of Lung Changes On Chest CT During Recovery From 2019 Novel Coronavirus (COVID-19) Pneumonia. Radiology. 2020 Feb 13:200370. doi: 10.1148/radiol.2020200370. [Epub ahead of print].

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

Silva S, Biendel C, Ruiz J, Olivier M, Bataille B, Geeraerts T, Mari A, Riu B, Fourcade O, Genestal M. Usefulness of cardiothoracic chest ultrasound in the management of acute respiratory failure in critical care practice. Chest. 2013 Sep;144(3):859-865. doi: 10.1378/chest.13-0167. — View Citation

Soldati G, Smargiassi A, Inchingolo R, Buonsenso D, Perrone T, Briganti DF, Perlini S, Torri E, Mariani A, Mossolani EE, Tursi F, Mento F, Demi L. Is There a Role for Lung Ultrasound During the COVID-19 Pandemic? J Ultrasound Med. 2020 Jul;39(7):1459-1462. doi: 10.1002/jum.15284. Epub 2020 Apr 7. Review. — View Citation

Soni NJ, Franco R, Velez MI, Schnobrich D, Dancel R, Restrepo MI, Mayo PH. Ultrasound in the diagnosis and management of pleural effusions. J Hosp Med. 2015 Dec;10(12):811-6. doi: 10.1002/jhm.2434. Epub 2015 Jul 28. Review. — View Citation

Sperandeo M, Filabozzi P, Varriale A, Carnevale V, Piattelli ML, Sperandeo G, Brunetti E, Decuzzi M. Role of thoracic ultrasound in the assessment of pleural and pulmonary diseases. J Ultrasound. 2008 Jun;11(2):39-46. doi: 10.1016/j.jus.2008.02.001. Epub 2008 Mar 17. — View Citation

Stefanidis K, Dimopoulos S, Kolofousi C, Cokkinos DD, Chatzimichail K, Eisen LA, Wachtel M, Karakitsos D, Nanas S. Sonographic lobe localization of alveolar-interstitial syndrome in the critically ill. Crit Care Res Pract. 2012;2012:179719. doi: 10.1155/2012/179719. Epub 2012 May 9. — View Citation

Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6. Review. — View Citation

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

Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. Erratum in: JAMA. 2020 Apr 21;323(15):1510. — View Citation

Zhao W, Zhong Z, Xie X, Yu Q, Liu J. Relation Between Chest CT Findings and Clinical Conditions of Coronavirus Disease (COVID-19) Pneumonia: A Multicenter Study. AJR Am J Roentgenol. 2020 May;214(5):1072-1077. doi: 10.2214/AJR.20.22976. Epub 2020 Mar 3. — View Citation

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

* Note: There are 28 references in allClick 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
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