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Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 + (eChoVid)

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ClinicalTrials.gov Identifier: NCT04335019
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between patients those who will require specific surveillance and those who can be sent back home. The recent French official recommendation of the French radiology society prescribe that chest X-ray do not have any place in the COVID-19+ management whereas the WHO stipulate that ultrasound machines may be useful for these patients [1-2]. Moreover, scattered recent publications tend to stress the interest of quick ultrasound imaging for COVID-19 suspected patients for screening purpose [2-5].

The aim of this observational historico-prospective study is to assess the risk of severe clinical outcomes (admission in continuous care unit (USC), invasive respiratory assistance, death) in patients suspected or diagnosed COVID-19+ as a function of initial pulmonary ultrasound abnormalities. These clinical outcomes are assessed through phone calls at D5, D15, M1.

The secondary objectives are:

  • Assessing the concordance between the severity of pulmonary lesions as detected by pulmonary ultrasound devices and the ones detected by CT-scanner, for patients who will undergo these two examinations.
  • Assessing the compared performances in detecting ultrasound pulmonary lesions for patients suspected or diagnosed COVID-19+, between an experimented operator and a newly trained operator.

Condition or disease Intervention/treatment
2019-nCoV (COVID-19) Interstitial Pneumonia Other: Pulmonary ultrasound

Detailed Description:

The practitioners involved at each site are

  • either emergency physicians who are experts in pulmonary ultrasound
  • either newly trained doctors who have received 30 minutes quick training in the fundamentals of pulmonary ultrasound.

The data collected under this protocol consists in:

  • data from clinical examination: blood pressure, heart rate, respiratory rate, saturation, signs of confusion, body temperature, calculation of the CRB65 and qSOFA score, date of onset of symptoms
  • Former patient journey: home, hospital, nursing home, others
  • Medical background
  • Recent use in the context of NSAID symptomatology
  • Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the context of a known pathology
  • Results and date of PCR-Covid-19 test
  • Pulmonary ultrasound results: quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).
  • The operator's identity and level of expertise will be indicated.

Patients follow-up happens at D5, D15 and D28 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.

Patients are informed orally (in the event of altered state of consciousness, their close relative present will benefit from this information) that they will be contacted remotely (at D5, D15 and D28) to inquire about their development.

Patients are also informed:

  • that any new information arising during the participation to the study, which could possibly modify his non opposition to this very participation, will be given
  • of the right to have communication of information, held by the investigators, concerning their health, during or at the end of the research.
  • Results of the chest scanner: typical COVID-19 and extent of the damage (minimal, moderate, severe)
  • Initial patient orientation: return home, simple hospitalization or continuous care unit (USC), with or without respiratory assistance (and of what type: invasive or non-invasive), death (date of death)
  • Whether or not to take chloroquine (on D0, D5, D15 or D28)
  • Patient follow-up: same data as during the initial orientation on day 0, day 5, day 15 and D28.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Other: Pulmonary ultrasound
    Pulmonary ultrasound results: quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).


Primary Outcome Measures :
  1. Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity [ Time Frame: at day0 ]

    Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity

    • There are few B lines at the lung bases
    • Bi-lateralization of B lines, numerous diffuse and / or curtain sign
    • Presence of signs of pulmonary consolidation, hepatization of the lung and air bronchogram)


Secondary Outcome Measures :
  1. Assessment of the agreement between a newly trained operator and an experienced operator of classification in one of the three stages of ultrasound gravity, by Cohen's kappa coefficient. [ Time Frame: at day0 ]
  2. Estimate in patients who had a CT-scan on D0, the agreement in the evaluation of the severity of lung lesions via ultrasound vs. CT-scan, by Cohen's kappa coefficient [ Time Frame: at day0 ]
  3. Measurement of the cumulative incidence of invasive mechanical ventilation and measurement of survival [ Time Frame: at day5 ]
  4. Measurement of the cumulative incidence of invasive mechanical ventilation and measurement of survival [ Time Frame: at day15 ]
  5. Measurement of the cumulative incidence of invasive mechanical ventilation and measurement of survival [ Time Frame: at day28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Suspected of COVID-19 infection or having a systematic COVID-19 screening
Criteria

Inclusion criteria :

  • > 18 years old
  • Suspected of COVID-19 infection or having a systematic COVID-19 screening

Exclusion criteria :

  • Patients on whom the ultrasonographic examination is not feasible for technical reasons (morbid obesity, thoracic extensive subcutaneous emphysema, absorbent subcutaneous infiltrations, ...)
  • Patients with comorbidities justifying priority intensive care, not linked to the COVID-19 condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335019


Contacts
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Contact: Mehdi BENCHOUFI, MD +33(0) 6 30 37 11 00 mehdi.benchoufi@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Mehdi BENCHOUFI, MD Assistance Publique - Hôpitaux de Paris
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04335019    
Other Study ID Numbers: APHP200390
2020-A00768-31 ( Other Identifier: IDRCB )
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary ultrasound
Diagnosis improvement
Screening
2019-nCoV (COVID-19)
Chest CT
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections