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

NCT04335019 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 328

Last updated 2021-12-01

No results posted yet for this study

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.
* Evaluate in suspected or COVID-19 patients, the risk of clinical worsening based on pulmonary ultrasound abnormalities during follow-up of hospitalized patients.
* Evaluate the ultrasound evolution profiles of pulmonary lesions in patients whose clinical evolution is favorable.
* Evaluate the incidence of thromboembolic events in patients who worsen secondarily.

Conditions

  • 2019-nCoV (COVID-19)
  • Interstitial Pneumonia

Interventions

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).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Mehdi BENCHOUFI, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-02
Primary Completion
2020-05-26
Completion
2020-05-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335019 on ClinicalTrials.gov