CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 233 enrolled
Drug / intervention
Simple chest tomographyother
Likely dose
Not stated in record
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Search/NCT04577105
NCT04577105N/ACompleted

Risk Factors, Prognosis and Findings by Computed Tomography in Patients Infected by COVID-19 and Its Association With Severity.

Instituto Nacional de Cardiologia Ignacio Chavez·observational·Posted Oct 6, 2020·Updated Oct 8, 2020

In Brief

An observational study evaluating Simple chest tomography for Covid19 and 3 related conditions. Completed, enrolled 233 participants across 1 site.

Detailed Summary

In the SARS-CoV2 pandemic, imaging studies proved its diagnostic utility to determine the severity of lung involvement. Computed tomography (CT) is a state-of-the-art study proven to be a highly sensitive diagnostic test complemented by RT-PCR testing to determine the disease and the degree of severity. In March 2020, the Dutch Society of Radiology developed a standardized assessment scheme for COVID-19 lung disease, called CO-RADS. This system proposes a level of suspicion of pulmonary involvement of COVID-19, based on the simple chest tomography findings. The level of suspicion ranges from very low (CO-RADS 1) to very high (CO-RADS 5), with two additional categories involving a technically deficient study (CO-RADS 0) and a positive RT-PCR test for SARS -CoV-2 known before tomography (CO-RADS 6). For its part, acute respiratory damage secondary to SARS-COV2 pneumonia causes acute respiratory distress syndrome, which warrants immediate medical attention. During the evaluation and triage of patients with suspected or confirmed SARS-COV2 infection, it is a challenge for health personnel given that the severity and clinical presentation is highly variable. The patient's risk stratification is carried out using previously established and validated risk scales and is a fundamental tool for making clinical decisions. Some of the risk indices and scales have been developed and used in the pandemic epicenters, such as China and Europe. Useful for the clinician is the national early warning scale (NEWS 2), severe disease risk assessment score (COVID-GRAM), the rapid severity index for COVID-19 (qCSI), evaluation score of Modified sequential organ failure (mSOFA), the sepsis-induced coagulopathy score (SIC), the ROX index as a predictor of success to the high-flow nasal cannula. The evaluation of the risk of thrombotic complications such as the Padua risk, of cardiac complications such as QT segment prolongation, through the Tisdale risk score. Risk stratification is essential in the current COVID-19 pandemic situation; upon admission, the clinician will discern if the patient requires in-hospital medical treatment, the risk of severe disease, and progression to assisted mechanical ventilation. This work aims to establish whether the severity of the findings identified by cardiac tomography upon admission and the risk established by the different established prognostic indices.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 6, 2020
Enrollment StartApr 1, 2020
Primary CompletionAug 31, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.7 years ago

Interventions

Simple chest tomographyother

The images were acquired with a Siemens 256-slice multidetector tomograph (SOMATOM DEFINITION FLASH 128x2) following the recommended parameters for low-dose simple chest tomography. The chest topogram was acquired using 35 mA, 100 Kv, and 6 mm slices, then the chest tomographic slices holding inspiration in a cephalocaudal direction with 80 mA, 100 Kv, a duration of 2.24 seconds, a pitch of 1, and slices 1 mm with a total of 110 DLP, which is calculated with the conversion factor for thorax a total of 1.5 mSv. Multiplanar reconstructions with Kernel filters B26f, B50f, and B70 for mediastinum and lung, respectively, at 1 mm slices.