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Completed

NCT Number: 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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Confirmed diagnosis of COVID-19 infection

    Time frame: 15 days

    One of the following criteria: Viral pneumonia, positive COVID-19 RT-PCR, or COVID-19 seroconversion (new onset of specific IgM or increased rate of specific IgG)

Secondary outcomes

  1. Incidence of unexpected COVID-19 positive patients admitted to the hospital

    Time frame: 24 hours from hospital admission

    Number of patients admitted to the hospital for an invasive procedure with COVID-19 detected by the combined strategy CT-scan plus RT-PCR at admission

  2. Number of contaminating events avoided by the early detection of COVID-19 patients

    Time frame: Hospital stay up to 15 days

    Number of events at high risk of viral transmission performed under accurate protection in COVID-19 patients detected by the early combined strategy, among hospitalization, unprotected in-hospital transportation, unprotected invasive procedure, in-bed chest X-ray, respiratory physiotherapy.

  3. Incidence of SARS-Cov-2 seroconversion

    Time frame: 15 days

    Modification of serologic status between hospital admission and day 15 or hospital discharge which ever occurs first.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: COVID-Scan

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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