Point Of Care UltraSonography for Risk-stratification of COVID-19 Patients
NCT ID: NCT04338100
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
307 participants
OBSERVATIONAL
2020-04-08
2020-06-23
Brief Summary
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While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation.
Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients.
Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date.
Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.
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Detailed Description
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Including patients have point-of-care lung ultrasonography (POCUS) performed within 48 hours following ED admission. The severity of lung damage is assessed using the lung ultrasonography score on 36 points for ARDS (POCUS score).
Apart POCUS score assessment, patients are managed as usual.
If a chest CT scan is performed, its result is collected and, in particular, the quantification of the extent of pulmonary lesions in percentage from 0 to 100%, carried out according to the recommendations of the French Society of Radiology.
For hospitalized patients, if possible, a second chest ultrasonography is performed on Day 5 +/- 3. The extent of lung damage is assessed by the POCUS score.
A follow-up is carried out on day 14 (D14) and the patient's status according to the "Ordinal Scale for Clinical Improvement" for COVID-19 from WHO is recorded.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Chest Ultrasound
Only one arm, all included patients having chest ultrasonography.
Follow-up at 14 days
Point of care chest ultrasonography and 14-day follow-up to assess the evolution of the infection and care requirement (invasive ventilation or death)
Interventions
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Follow-up at 14 days
Point of care chest ultrasonography and 14-day follow-up to assess the evolution of the infection and care requirement (invasive ventilation or death)
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old,
* Not requiring respiratory assistance and/or other intensive care
* Not subject to a limitation of active therapeutics
Exclusion Criteria
* Any reason making chest ultrasonography impossible
* Any reason making 14-day follow-up impossible
* Patient opposition to research participation.
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Philippe LE CONTE, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Nantes
Thomas FLAMENT, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Tours
Louis SOULAT, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Rennes
Nicolas MARJANOVIC, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Poitiers
Francis COUTURAUD, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Brest
Laure BAUDIN, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital of Cholet
Karim TAZAROURTE, Pr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon (University Hospital of Lyon)
Thomas DELOMAS, Dr
Role: PRINCIPAL_INVESTIGATOR
Hospital of Saint-Lô
Luc-Marie JOLY, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Florence DUPRIEZ
Brussels, , Belgium
MORIN François
Angers, , France
COUTURAUD Francis
Brest, , France
BAUDIN Laure
Cholet, , France
TAZAROURTE Karim
Lyon, , France
LE CONTE Philippe
Nantes, , France
MARJANOVIC Nicolas
Poitiers, , France
SOULAT Louis
Rennes, , France
JOLY Luc-Marie
Rouen, , France
DELOMAS Thomas
Saint-Lô, , France
FLAMENT Thomas
Tours, , France
Countries
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References
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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.
Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
Morin F, Douillet D, Hamel JF, Rakotonjanahary J, Dupriez F, Savary D, Aube C, Riou J, Dubee V, Roy PM. Point-of-care ultrasonography for risk stratification of non-critical COVID-19 patients on admission (POCUSCO): a study protocol of an international study. BMJ Open. 2021 Feb 10;11(2):e041118. doi: 10.1136/bmjopen-2020-041118.
Related Links
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A Preliminary Study on the Ultrasonic Manifestations of Peripulmonary Lesions of Non-Critical Novel Coronavirus Pneumonia (COVID-19)
Other Identifiers
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2020-A00782-37
Identifier Type: -
Identifier Source: org_study_id
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