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

Completed

• Conditions: SARS-Cov-2; COVID 19

• Registration Number: NCT04355715
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-20
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confirmed diagnosis of COVID-19 infection	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 Outcome Measures

Name	Time	Method
Number of contaminating events avoided by the early detection of COVID-19 patients	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.
Incidence of SARS-Cov-2 seroconversion	15 days	Modification of serologic status between hospital admission and day 15 or hospital discharge which ever occurs first.
Incidence of unexpected COVID-19 positive patients admitted to the hospital	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

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France