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

NCT05228717 | Unknown

• 1 other identifier: 1590419
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 4

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Utilization of traditional radiography

  From admission to 21 days, or endpoint reached

• Individual clinical outcomes

  From admission to 21 days, or endpoint reached

Study Arms (1)

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

Interventions

Point of Care Ultrasound DIAGNOSTIC_TEST

q48-72h point of care ultrasound of the lungs, heart, and IVC (inferior vena cava)

COVID+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients with COVID-19 Pneumonia/hypoxemic respiratory failure requiring at least 3L of O2.

You may qualify if:

• 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.

You may not qualify if:

• age \< 18 years old, pregnant patients, or patients that verbally refuse participation

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead

Study Sites (4)

UCLA-Ronald Reagan

Los Angeles, California, 90095, United States

RECRUITING

Olive View-UCLA

Sylmar, California, 91342, United States

RECRUITING

SUNY Downstate

New York, New York, 11203, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Related 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.

  PMID: 32101510 BACKGROUND

• 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.

  PMID: 20851923 BACKGROUND

• 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. No abstract available.

  PMID: 32203708 BACKGROUND

• 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(1):50. doi: 10.1186/1465-9921-15-50.

  PMID: 24758612 BACKGROUND

• 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.

  PMID: 32174128 BACKGROUND

• 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.

  PMID: 32017661 BACKGROUND

• Clerkin K, Fried J, Raikhelkar J, et al. Coronavirus Disease 2019 (COVID-19) and Cardiovascular Disease. Circulation. 2020 Mar 21. doi: 10.1161/CIRCULATIONAHA.120.046941.

  BACKGROUND

• 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.

  PMID: 18442425 BACKGROUND

• 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.

  PMID: 25592455 BACKGROUND

• 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.

  PMID: 32109013 BACKGROUND

• 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.

  PMID: 24791173 BACKGROUND

• 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. doi: 10.1155/2014/472136. Epub 2014 Jun 13.

  PMID: 24927376 BACKGROUND

• 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. doi: 10.1097/00000542-200401000-00006.

  PMID: 14695718 BACKGROUND

• Lichtenstein DA, Lascols N, Meziere 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.

  PMID: 14722643 BACKGROUND

• 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 Societe de Reanimation de Langue Francaise statement on competence in critical care ultrasonography. Chest. 2009 Apr;135(4):1050-1060. doi: 10.1378/chest.08-2305. Epub 2009 Feb 2.

  PMID: 19188546 BACKGROUND

• 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.

  PMID: 31418060 BACKGROUND

• Pan F, Ye T, Sun P, Gui S, Liang B, Li L, Zheng D, Wang J, Hesketh RL, Yang L, Zheng C. Time Course of Lung Changes at Chest CT during Recovery from Coronavirus Disease 2019 (COVID-19). Radiology. 2020 Jun;295(3):715-721. doi: 10.1148/radiol.2020200370. Epub 2020 Feb 13.

  PMID: 32053470 BACKGROUND

• 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. No abstract available.

  PMID: 32166346 BACKGROUND

• 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.

  PMID: 23670087 BACKGROUND

• 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. No abstract available.

  PMID: 32198775 BACKGROUND

• 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.

  PMID: 26218493 BACKGROUND

• 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.

  PMID: 23396553 BACKGROUND

• 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.

  PMID: 22645669 BACKGROUND

• 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.

  PMID: 22392031 BACKGROUND

• 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.

  PMID: 32167524 BACKGROUND

• 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.

  PMID: 32125362 BACKGROUND

• 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.

  PMID: 32125873 BACKGROUND

• 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.

  PMID: 32171076 BACKGROUND

MeSH Terms

Conditions

Lung Injury; COVID-19; Hypoxia; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Central Study Contacts

James Murphy, MD

CONTACT

7472103107; jjmurphy@mednet.ucla.edu

Alan Chiem, MD

CONTACT

7472103107; achiem@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: February 8, 2022
• Study Start: November 10, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

US (4)