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

NCT04355715 | Completed

• 1 other identifier: RECHMPL20_0223
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19; SARS-Cov-2

Keywords

COVID-19 infection or paucy-symptomatic carriage; In-hospital screening; Chest CT-scan

Outcome Measures

Primary Outcomes (1)

• Confirmed diagnosis of COVID-19 infection

  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)

  15 days

Secondary Outcomes (3)

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

  24 hours from hospital admission

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

  Hospital stay up to 15 days

• Incidence of SARS-Cov-2 seroconversion

  15 days

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

Plasma: preoperative, ICU admission at POD0 and POD1 samples

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 Officials

• Philippe Gaudard, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: April 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 20, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)