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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04335019
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Mehdi BENCHOUFI, MD
Principal Investigator Affiliation Assistance Publique - Hôpitaux de Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 2019-nCoV (COVID-19), Interstitial Pneumonia
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Mehdi BENCHOUFI, MD

mehdi.benchoufi@aphp.fr

+33(0) 6 30 37 11 00

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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