Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Reduction of Diffusion of Lung CO (DLCO, single breath technique) |
Reduction below 80% of predicted values of DLCO |
T1 at 6 months from discharge |
|
Primary |
Reduction of Diffusion of Lung CO (DLCO, single breath technique) |
Reduction below 80% of predicted values of DLCO |
T2 at 12 months from discharge |
|
Secondary |
Alterations in 6 minute walking test (6MWT) |
reduction in maximum distance walked |
T1 at 6 months from discharge |
|
Secondary |
Alterations in 6 minute walking test (6MWT) |
reduction in maximum distance walked |
T2 at 12 months from discharge |
|
Secondary |
Alterations in 6 minute walking test (6MWT) |
reduction in oxygen saturation nadir |
T1 at 6 months from discharge |
|
Secondary |
Alterations in 6 minute walking test (6MWT) |
reduction in oxygen saturation nadir |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Forced Vital Capacity (FVC, %) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Forced Vital Capacity (FVC, %) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Forced Vital Capacity (FVC, L) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Forced Vital Capacity (FVC, L) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Vital Capacity (VC, %) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Vital Capacity (VC, %) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Vital Capacity (VC, L) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Vital Capacity (VC, L) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Forced Expiratory Volume in the 1st second (FEV1, L) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Forced Expiratory Volume in the 1st second (FEV1, %) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Forced Expiratory Volume in the 1st second (FEV1, L) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Forced Expiratory Volume in the 1st second (FEV1, L%) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Total Lung Capacity (TLC, L) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Total Lung Capacity (TLC, %) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Total Lung Capacity (TLC, L) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
reduction of Total Lung Capacity (TLC, %) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
alterations of Residual Volume (RV,%) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
alterations of Residual Volume (RV, L) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
alterations of Residual Volume (RV, L) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
alterations of Residual Volume (RV, %) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
increase of Specific Airway Resistance (sRAW) (absolute value) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
increase of Specific Airway Resistance (sRAW) (%) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
increase of Specific Airway Resistance (sRAW) (absolute value) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
increase of Specific Airway Resistance (sRAW) (%) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
alterations of Motley Index (VR/CPT) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
alterations of Motley Index (VR/CPT) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of pletismography |
alterations of Tiffeneau Index (IT) |
T1 at 6 months from discharge |
|
Secondary |
Alterations of pletismography |
alterations of Tiffeneau Index (IT) |
T2 at 12 months from discharge |
|
Secondary |
Alterations of Arterial Blood Gas Analysis |
reduction of PaO2 mmHg |
T1 at 6 months from discharge |
|
Secondary |
Alterations of Arterial Blood Gas Analysis |
reduction of PaO2 mmHg |
T2 at 12 months from discharge |
|
Secondary |
Alterations of Arterial Blood Gas Analysis |
alteration of PaCO2 mmHg |
T1 at 6 months from discharge |
|
Secondary |
Alterations of Arterial Blood Gas Analysis |
alteration of PaCO2 mmHg |
T2 at 12 months from discharge |
|
Secondary |
Abnormal Dyspnea Score |
Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome) |
T1 at 6 months from discharge |
|
Secondary |
Abnormal Dyspnea Score |
Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome) |
T2 at 12 months from discharge |
|
Secondary |
Presence and extension of abnormal pulmonary lung sounds at auscultation |
Presence and extension of abnormal pulmonary lung sounds at auscultation |
T1 at 6 months from discharge |
|
Secondary |
Presence and extension of abnormal pulmonary lung sounds at auscultation |
Presence and extension of abnormal pulmonary lung sounds at auscultation |
T2 at 12 months from discharge |
|
Secondary |
Presence and extension of radiological alterations at chest X-ray |
Presence and extension of radiological alterations at chest X-ray |
T1 at 6 months from discharge |
|
Secondary |
Presence and extension of radiological alterations at chest CT scan |
Presence and extension of radiological alterations at chest CT scan |
T2 at 12 months from discharge |
|