Clinical trial NCT04355715: Combination of Chest Scanography and Nasal Viral Detection Test to Detect COVID-19 Positive Patients Before Surgical Intervention in a University Hospital During Coronavirus Pandemia
Official title: Evaluation of a COVID-19 Screening Strategy Combining Chest Low Dose CT and RT-PCR Test for Patients Admitted for Surgical or Interventional Procedures During the COVID 19 Outbreak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
SARS-Cov-2
Keywords: COVID-19 infection or paucy-symptomatic carriage
In-hospital screening
Chest CT-scan
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to hospital for a surgical or interventional procedure under general anesthesia or at risk of aerosolization during the COVID-19 outbreak and screened with chest CT-scan and nasopharyngeal RT-PCR to detect SARS-Cov-2 infection or carriage

Brief summary: This research aims to improve the screening for COVID-19 upon admission to the Montpellier University Hospital for an act under general anesthesia or at high risk of transmission of the virus. Indeed, routine nasal swabs present many false negatives (60 to 70%) and many patients with the coronavirus have little or no symptoms. Performing a chest CT scan can reveal early signs very suggestive of viral pneumoniae due to the new coronavirus without additional risk compared to a simple chest X-ray (no injection of contrast medium, low exposure).

The objective is to assess the sensitivity of the diagnosis of COVID-19 by carrying out a nasopharyngeal RT-PCR and a low dose thoracic scanography at the hospital admission of patients scheduled to a procedure under general anesthesia or at risk of aerosolization (surgery, endoscopy, procedures involving risk of interventional radiology) in order to limit the risks of transmission to healthcare professionals or other patients and to rationalize the use of protective equipment.

This is an observational research without modification of care in the setting of COVID-19 pandemia. All clinical and biological data will be issued from routine care and medical charts. Routine use of CT scan and nasal swabs is an institutional approved strategy. Serologic tests will be performed as soon as available from serum collection collected after routine blood analysis. All data will be anonymously recorded after information and non-opposition of the patient.


Eligibility criteria: Inclusion criteria:

* Scheduled or unscheduled surgical or interventional procedure with at least one night in hospital
* Chest CT-scan within the first 24 hours
* Nasopharyngeal swaps within 24 hours before or after hospital admission

Exclusion criteria :

* Age under 18 years
* Patient with restriction of freedom
* Vital surgical emergency
* Direct admission to the COVID dedicated hospital
* Opposition to data utilization

Primary outcomes:
measure: Confirmed diagnosis of COVID-19 infection
timeFrame: 15 days
Secondary outcomes:
measure: Incidence of unexpected COVID-19 positive patients admitted to the hospital
timeFrame: 24 hours from hospital admission
measure: Number of contaminating events avoided by the early detection of COVID-19 patients
timeFrame: Hospital stay up to 15 days
measure: Incidence of SARS-Cov-2 seroconversion
timeFrame: 15 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Philippe Gaudard, MD
role: PRINCIPAL_INVESTIGATOR
References: