Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV). Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.
SARS-CoV-2 related disease started in December 2019 in the Chinese city of Wuhan, rapidly spread and became an international health emergency. Pneumonia is a frequent element of COVID-19, its pathogenic mechanisms are not entirely known and some patients develop various degrees of respiratory failure and need oxygen therapy up to NIV-CPAP) and IMV. Some pathology studies in COVID-19 pneumonia show ARDS-like lesions associated to inflammatory reaction. It is known that pulmonary inflammatory damage can lead to fibrotic sequelae or to the development of pulmonary emphysema. The main target of the study is to use non invasive methods (pletysmography, DLCO assessment, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) to identify pulmonary sequelae in patients hospitalised because of respiratory failure in COVID-19 pneumonia. Study design: multicentre observational cohort study. Patients will be divided in three arms according to maximum ventilatory/oxygen support received during hospital stay: 1. patients who received only oxygen therapy 2. patients who received non invasive ventilation (NIV-CPAP) 3. patients who received invasive mechanical ventilation (IMV) All patients undergo a clinical evaluation at 6 months from hospital discharge (T1) and a second clinical evaluation at 12 months from hospital discharge (T2). During (T1) patients undergo spirometry with pletysmography and DLCO assessment, six minute walking test, standard chest X-ray, arterial blood gas analysis if SaO2 \< 93% in room air, dyspnea score and presence and extension of lung sounds at pulmonary auscultation. During (T2) patients will undergo spirometry with pletysmography and DLCO assessment, six minute walking test, High Resolution CT scan (HRTC) of the thorax, arterial blood gas analysis if SaO2 \< 93% in room air, dyspnea score and presence and extension of lung sounds at pulmonary auscultation).
Study Type
OBSERVATIONAL
Enrollment
300
San Gerardo Hospital
Monza, MB, Italy
Reduction of Diffusion of Lung CO (DLCO, single breath technique)
Reduction below 80% of predicted values of DLCO
Time frame: T1 at 6 months from discharge
Reduction of Diffusion of Lung CO (DLCO, single breath technique)
Reduction below 80% of predicted values of DLCO
Time frame: T2 at 12 months from discharge
Alterations in 6 minute walking test (6MWT)
reduction in maximum distance walked
Time frame: T1 at 6 months from discharge
Alterations in 6 minute walking test (6MWT)
reduction in maximum distance walked
Time frame: T2 at 12 months from discharge
Alterations in 6 minute walking test (6MWT)
reduction in oxygen saturation nadir
Time frame: T1 at 6 months from discharge
Alterations in 6 minute walking test (6MWT)
reduction in oxygen saturation nadir
Time frame: T2 at 12 months from discharge
Alterations of pletismography
reduction of Forced Vital Capacity (FVC, %)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
reduction of Forced Vital Capacity (FVC, %)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
reduction of Forced Vital Capacity (FVC, L)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
reduction of Forced Vital Capacity (FVC, L)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
reduction of Vital Capacity (VC, %)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
reduction of Vital Capacity (VC, %)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
reduction of Vital Capacity (VC, L)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
reduction of Vital Capacity (VC, L)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
reduction of Total Lung Capacity (TLC, L)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
reduction of Total Lung Capacity (TLC, %)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
reduction of Total Lung Capacity (TLC, L)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
reduction of Total Lung Capacity (TLC, %)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
alterations of Residual Volume (RV,%)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
alterations of Residual Volume (RV, L)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
alterations of Residual Volume (RV, L)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
alterations of Residual Volume (RV, %)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
increase of Specific Airway Resistance (sRAW) (absolute value)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
increase of Specific Airway Resistance (sRAW) (%)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
increase of Specific Airway Resistance (sRAW) (absolute value)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
increase of Specific Airway Resistance (sRAW) (%)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
alterations of Motley Index (VR/CPT)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
alterations of Motley Index (VR/CPT)
Time frame: T2 at 12 months from discharge
Alterations of pletismography
alterations of Tiffeneau Index (IT)
Time frame: T1 at 6 months from discharge
Alterations of pletismography
alterations of Tiffeneau Index (IT)
Time frame: T2 at 12 months from discharge
Alterations of Arterial Blood Gas Analysis
reduction of PaO2 mmHg
Time frame: T1 at 6 months from discharge
Alterations of Arterial Blood Gas Analysis
reduction of PaO2 mmHg
Time frame: T2 at 12 months from discharge
Alterations of Arterial Blood Gas Analysis
alteration of PaCO2 mmHg
Time frame: T1 at 6 months from discharge
Alterations of Arterial Blood Gas Analysis
alteration of PaCO2 mmHg
Time frame: T2 at 12 months from discharge
Abnormal Dyspnea Score
Modified Medical Research Council - mMRC \> 0 (minimum 0, maximum 4; higher score means worse outcome)
Time frame: T1 at 6 months from discharge
Abnormal Dyspnea Score
Modified Medical Research Council - mMRC \> 0(minimum 0, maximum 4; higher score means worse outcome)
Time frame: T2 at 12 months from discharge
Presence and extension of abnormal pulmonary lung sounds at auscultation
Presence and extension of abnormal pulmonary lung sounds at auscultation
Time frame: T1 at 6 months from discharge
Presence and extension of abnormal pulmonary lung sounds at auscultation
Presence and extension of abnormal pulmonary lung sounds at auscultation
Time frame: T2 at 12 months from discharge
Presence and extension of radiological alterations at chest X-ray
Presence and extension of radiological alterations at chest X-ray
Time frame: T1 at 6 months from discharge
Presence and extension of radiological alterations at chest CT scan
Presence and extension of radiological alterations at chest CT scan
Time frame: T2 at 12 months from discharge
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