Risk Factors, Prognosis and Findings by Computed Tomography in Patients Infected by COVID-19 and Its Association With Severity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Percentage of patients requiring endotracheal intubation
研究概览
简要总结
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.
详细描述
Introduction
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).
Acute respiratory damage secondary to SARS-COV2 pneumonia causes acute respiratory distress syndrome, which must meet the Berlin criteria. The evaluation and triage of patients with suspected or confirmed SARS-COV2 infection is a challenge for emerging healthcare systems. The risk stratification of the patient is carried out with previously established and validated risk scales.
However, scales such as the national early warning scale (NEWS 2) are an option for health personnel, NEWS 2 determines the degree of illness of a patient and promotes intensive care intervention. It includes assessing oxygen saturation, hypercapnic respiratory failure (usually chronic obstructive pulmonary disease), confusion, disorientation, delirium, or any reduction in the Glasgow coma scale as potential findings of clinical deterioration. With a score of 0-4, it grants a low risk. It recommends the evaluation carried out by a competent registered nurse or equivalent to decide the change in the frequency of clinical follow-up or the intensification of care, on the contrary with a score of more than 7, grants high risk and recommends Emergency Assessment by a clinical or intensive care team and is usually transferred to a higher level of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Patients who have had an arterial blood gas.
排除标准
- •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.
结局指标
主要结局
Percentage of patients requiring endotracheal intubation
时间窗: 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
Assessment of the level of suspicion of SARS-CoV2 infection
时间窗: 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).
Evaluate the severity degree of pulmonary affection by chest computed tomography
时间窗: 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
Death from any cause
时间窗: From admission to discharge, up to 1 week
Patients who present fatal descent during hospitalization will be evaluated.
次要结局
- National Early Warning Scale (NEWS 2)(At hospital admission)
- COVID-GRAM severe illness risk score(At hospital admission)
- Alveolar-arterial gradient of oxygen(At hospital admission)
- Modified Sequential Organ Failure Assessment (mSOFA)(At hospital admission)
- Sepsis-induced coagulopathy (SIC)(At hospital admission)
- Rapid Severity Index for COVID-19 (qCSI)(At hospital admission)
- Neutrophil-Lymphocyte Ratio (NLR)(At hospital admission)
- Berlin Criteria for Acute Respiratory Distress Syndrome(At hospital admission)
研究者
Maria Elena Soto, MsC and PhD
Principal investigator
Instituto Nacional de Cardiologia Ignacio Chavez