Management of Patients Suspected of COVID 19 With Ultra Low Dose Thoracic Scanner

NCT04794361 | Completed

• 1 other identifier: Local 2020/JF1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• reading of LD and ULD acquisitions

  Diagnostic performance of ULD vs LD scanner for the diagnosis of COVID-19 pneumopathy

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients having had the LD and ULD acquisitions

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Julien FRANDON

Nîmes, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

pcr Covid-19 and viral load, inflammation marker (CRP)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 12, 2021
• Study Start: March 5, 2020
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

FR (1)