Point Of Care UltraSonography for Risk-stratification of COVID-19 Patients

NCT04338100 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 307

Last updated 2022-03-22

No results posted yet for this study

Summary

COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue.

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.

Conditions

  • COVID
  • Coronavirus Infection

Interventions

PROCEDURE

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)

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Philippe LE CONTE, Pr · University Hospital of Nantes

  • Thomas FLAMENT, Dr · University Hospital of Tours

  • Louis SOULAT, Pr · University Hospital of Rennes

  • Nicolas MARJANOVIC, Dr · University Hospital of Poitiers

  • Francis COUTURAUD, Dr · University Hospital of Brest

  • Laure BAUDIN, Dr · Hospital of Cholet

  • Karim TAZAROURTE, Pr · Hospices Civils de Lyon (University Hospital of Lyon)

  • Thomas DELOMAS, Dr · Hospital of Saint-Lô

  • Luc-Marie JOLY, Pr · University Hospital, Rouen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-08
Primary Completion
2020-06-05
Completion
2020-06-23

Countries

  • Belgium
  • France

Study Locations

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Entities

Diseases

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 NCT04338100 on ClinicalTrials.gov