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Management of Patients Suspected of COVID 19 With Ultra Low Dose Thoracic Scanner (COVID-19 ULD)

10. mars 2021 oppdatert av: Centre Hospitalier Universitaire de Nīmes

The year 2020 was marked by the emergence of a new respiratory disease: COVID19 related to an infection with the coronavirus SARS-CoV-2 (name given by the WHO on February 11, 2020). Initially appearing in China, in the province of Hubei, this epidemic has rapidly spread to be declared a global pandemic on March 12, 2020 by the WHO.Given the current context of the COVID-19 epidemic, strict hygiene measures have been taken in scanning rooms with systematic bio-cleaning. Strategies have been modified as a matter of urgency, with changes in the practices of electro radiology manipulators who work in "isolation" to avoid contamination. The number of scanners has increased exponentially following the curve of the epidemic, making it more and more difficult to systematically check the images before the patient leaves the room. To ensure sufficient image quality for interpretation of all scans, a complementary acquisition in ULD, with very low exposure, was systematically added to the acquisition protocol. The standard acquisition in LD, associated with this acquisition in ULD remain well below the diagnostic reference thresholds dictated by the nuclear safety authority (NRD: 350 mGy.cm. In Nîmes: LD: 100 to 150 mGy.cm and ULD: < 15 mGy.cm). These two acquisitions allow us to avoid breathing and movement artifacts, etc., without having to have the patients return for a new scan in case of a bad acquisition. This avoids an overexposure of the staff to the risk of infection by the SARS-CoV-2 virus.

The main objective of this retrospective study is to evaluate the diagnostic performance of ULD vs. LD for the accurate diagnosis of COVID-19 pneumopathy which presents a particular ground glass pattern

Our study will demonstrate that the ULD scanner can be used in the search for COVID-19 pneumopathy and thus limit the exposure of patients to X-rays, especially since thoracic scans are often repeated.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Main objective To evaluate the diagnostic performance of ULD vs. LD scanning for the diagnosis of COVID-19 lung disease.

Primary endpoint LD and ULD acquisitions will be anonymized and randomized in a read list. Double reading of scans in a randomized and blinded manner of the results of LD and ULD acquisitions of chest scans performed for suspected COVID-19 by 2 radiologists (one junior and one senior). Scans will be classified as non-COVID and COVID. The reference will be the LD scan. In case of discrepancy, a third senior radiologist will be asked and the decision will be made by consensus.

Secondary objectives

  • Objective evaluation of image quality (signal, noise, contrast to noise ratio)
  • Subjective evaluation of image quality and confidence in interpretation.
  • Specific study of ground glass signal in ULD

Secondary evaluation criteria

  • Measurement of signal and noise in the image using ROIs positioned in the lung, trachea, fat, which measure the average signal intensity and its standard deviation. These measurements will be performed on LD and ULD acquisitions at the same locations.
  • Likert scale to subjectively assess image quality and confidence in the diagnosis.
  • Specific measurement of signal and noise in the ground glass using ROI positioned within the ground glass that measures the average signal intensity and its standard deviation. This measurement will be performed on LD and ULD acquisitions at the same location.

Population concerned Patients of the Nîmes University Hospital who have had a prescription for a thoracic CT scan for suspected COVID-19 since March 5, 2020 (beginning of the COVID-19 protocol) and until April 5. Patients having had the LD and ULD acquisitions.

Studietype

Observasjonsmessig

Registrering (Faktiske)

400

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients from the Nîmes University Hospital who had a chest CT prescription for suspected COVID-19 since March 5, 2020 (start of the COVID-19 protocol) and until April 5

Beskrivelse

Inclusion Criteria:

Patients having had the LD and ULD acquisitions

Exclusion Criteria:

  • scanner not passed through the COVID circuit, no ULD acquisition performed

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
reading of LD and ULD acquisitions
Tidsramme: day 1
Diagnostic performance of ULD vs LD scanner for the diagnosis of COVID-19 pneumopathy
day 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mars 2020

Primær fullføring (Faktiske)

5. mai 2020

Studiet fullført (Faktiske)

5. mai 2020

Datoer for studieregistrering

Først innsendt

10. mars 2021

Først innsendt som oppfylte QC-kriteriene

10. mars 2021

Først lagt ut (Faktiske)

12. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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