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Risk Factors and Computed Tomography Findings in COVID-19.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04577105
Recruitment Status : Completed
First Posted : October 6, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Elena Soto, MsC and PhD, Instituto Nacional de Cardiologia Ignacio Chavez

Brief 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.


Condition or disease Intervention/treatment
Covid19 ARDS Pneumonia, Viral Computed Tomography Diagnostic Test: Simple chest tomography

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Study Type : Observational
Actual Enrollment : 233 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors, Prognosis and Findings by Computed Tomography in Patients Infected by COVID-19 and Its Association With Severity.
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Group/Cohort Intervention/treatment
Suspected, probable, or confirmed COVID-19 case
Patients who come to the emergency room with symptoms compatible with a suspected, probable, or confirmed case of SARS-CoV2 infection, in which a chest computed tomography (CT) scan was requested for suspected COVID-19 pneumonia, will be evaluated. On April 1 and August 28, 2020.
Diagnostic Test: Simple chest tomography
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.
Other Name: CT




Primary Outcome Measures :
  1. Assessment of the level of suspicion of SARS-CoV2 infection [ Time Frame: At hospital admission ]
    CO-RADS will categorize the level of suspicion of COVID-19. 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).

  2. Evaluate the severity degree of pulmonary affection by chest computed tomography [ Time Frame: At hospital admission ]
    It will be a semi-quantitative assessment of lung lobe lesions' extent considering five lobes (upper right lobes, middle lobe, lower right lobe, upper left lobe, and lower left lobe). Each of these lobes, depending on their condition, is scored from 1 to 5, with 1 <5%, 2 from 5 to 25%, 3> 25 to 50%, 4 from> 50 to 75% and the number 5 greater than 75%. With this, it is grouped into mild affection from 1 to 5 points, moderate from 5 to 15 points, and greater than 15 points as severe affection

  3. Percentage of patients requiring endotracheal intubation [ Time Frame: From admission to discharge, up to 1 week ]
    The requirement for orotracheal intubation and the start of assisted mechanical ventilation after admission will be evaluated

  4. Death from any cause [ Time Frame: From admission to discharge, up to 1 week ]
    Patients who present fatal descent during hospitalization will be evaluated.


Secondary Outcome Measures :
  1. Modified Sequential Organ Failure Assessment (mSOFA) [ Time Frame: At hospital admission ]
    The evaluation of multiple organ failure secondary to sepsis will be carried out using the mSOFA scale, which can predict in-hospital mortality and 30 days, with a minimum score of 0-7 that translates mortality of 0% and a score greater than 11 translates mortality of 58%.

  2. Sepsis-induced coagulopathy (SIC) [ Time Frame: At hospital admission ]
    The sepsis-induced coagulopathy score scale (SIC) refers to the diagnosis of coagulopathy when the score is greater than 4 or the INR is greater than or equal to 3.

  3. National Early Warning Scale (NEWS 2) [ Time Frame: At hospital admission ]
    A score of 0-4 confers a low risk; on the contrary, a score of more than 7 gives a high risk.

  4. COVID-GRAM severe illness risk score [ Time Frame: At hospital admission ]
    It establishes three risk groups: the mild one with a risk of critical illness of less than 1.7% and the high risk of more than 40.4%.

  5. Rapid Severity Index for COVID-19 (qCSI) [ Time Frame: At hospital admission ]
    A score less than or equal to 3 gives a low risk with a critical illness risk of 4%, while a score of 10-12 gives a high risk and a critical illness probability of 57%.

  6. Neutrophil-Lymphocyte Ratio (NLR) [ Time Frame: At hospital admission ]
    A ratio of 6-8 translates mild physiological stress, while a ratio of more than 18 a severe physiological stress level.

  7. Alveolar-arterial gradient of oxygen [ Time Frame: At hospital admission ]
    The gradient Aa O2 = [(FiO2) × (Atmospheric pressure - Pressure of H2O) - (PaCO2 / 0.8)] - PaO2 of ABG is calculated and a normal gradient with age is estimated with the following formula: Estimate of normal gradient = (Age / 4) + 4. The gradient is increased in conditions such as ARDS, PE, and cardiac failure.

  8. Berlin Criteria for Acute Respiratory Distress Syndrome [ Time Frame: At hospital admission ]

    Required criteria (must have all three of the following): Timing within 1 week of clinical insult or new/worsening respiratory symptoms, Chest XR shows bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules Respiratory failure not fully explained by cardiac failure/fluid overload Risk factor (one of the following): Risk factor for ARDS present (e.g. pneumonia, trauma, sepsis, pancreatitis).

    Objective assessment (Echo) excludes hydrostatic edema.

    Severity (based on oxygenation, select one of the following): Mild: PaO₂/FiO₂ >200 to ≤300 mmHg with PEEP OR CPAP ≥5 cm H₂O, Moderate: PaO₂/FiO₂ >100 to ≤200 mmHg with PEEP ≥5 cm H₂O and Severe: PaO₂/FiO₂ ≤100 mmHg with PEEP ≥5 cm H₂O




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the emergency department, coronary unit, or post-surgical therapy unit of the National Institute of Cardiology Ignacio Chávez.
Criteria

Inclusion Criteria:

  • Patients who go to the emergency department meet the criteria for a suspected, probable, or confirmed case of COVID-19 infection.
  • Patients who have undergone a simple chest tomography during their stay in the INC Emergency Department.
  • Patients whose information and data availability can be obtained through the triage's electronic clinical record carried out in the emergency department and coronary unit.
  • Patients with clinical data, laboratory data, oxygen saturation, and inspired oxygen fraction are necessary to evaluate prognostic indices.
  • Test for SARS-CoV2 infection by RT-PCR reported as positive, negative, or not performed, but with suspicion of COVID-19.
  • Patients who have had an arterial blood gas.

Exclusion Criteria:

  • Patients with incomplete clinical, laboratory, blood gas parameters.
  • Patients in whom saturation and initial FiO2 are not reported.
  • Patients referred to another Hospital during their initial evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577105


Locations
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Mexico
Instituto Nacional Ignacio Chavez
Ciudad de mexico, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
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Principal Investigator: Sergio Andres Criales Vera, MD Insituto Nacional de Cardiologia Ignacio Chavez
Publications of Results:

Other Publications:

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Responsible Party: Maria Elena Soto, MsC and PhD, Principal investigator, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT04577105    
Other Study ID Numbers: 20-1177
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Elena Soto, MsC and PhD, Instituto Nacional de Cardiologia Ignacio Chavez:
Risk Factors
SARS-CoV2
Computed Tomography
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases