Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Assessment of change of lung vital capacity |
The vital capacity of the lungs was assessed with spirotest (Riester, mod. 5260). The subject stood with legs hip-width apart. For each measurement, disposable cardboard mouthpieces were used. The examined person held the device vertically with both hands. At the examiner's command, subject took in as much air as possible, then tightly bit the mouthpiece with his mouth, and with all of their strength, exhaled air into the device for as long as possible. The subject had only 1 attempt-measured values were recorded with an accuracy of 50 mL. |
twice: before and immediately after procedure administration in both groups |
|
Primary |
Assessment of change of blood oxygen saturation |
Testing blood oxygen saturation was performed in a sitting position with digital pulseoximeter CMS50D. The device was put on the second finger of the left hand each time. The highest value displayed by the pulseoximeter within 30 s was recorded with an accuracy of 1%. |
twice: before and immediately after procedure administration in both groups |
|
Primary |
Assessment of change of chest circumference |
The chest circumference was measured with a measuring tape, wrapped horizontally around the chest at the level of the xiphoid process. The subject was standing with feet hip-width apart, arms hanging along the body. At the command, the subject would take a maximum breathe in (first measurement) and exhale to the maximum for the next (second measurement). Obtained values were recorded with an accuracy of 0.5 cm. |
twice: before and immediately after procedure administration in both groups |
|
Primary |
Asessment of change of Peak Expiratory Flow |
Dynamic spirometry test was performed, assessing the peak expiratory flow (PEF) measured in liters per second [l/s]. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. |
twice: before and immediately after procedure administration in both groups |
|
Primary |
Assessment of change of Peak Inspiratory Flow |
Dynamic spirometry test was performed, assessing the peak inspiratory flow (PIF) measured in liters per second [l/s]. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. |
twice: before and immediately after procedure administration in both groups |
|
Primary |
Assessment of change of Forced Vital Capacity |
Dynamic spirometry test was performed, assessing the forced vital capacity (FVC), measured in liters. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". |
twice: before and immediately after procedure administration in both groups |
|
Primary |
Assessment of change of Maximum Expiratory Flow. |
Dynamic spirometry test was performed, assessing the maximum expiratory flow (MEF), measured in liters per second. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. |
twice: before and immediately after procedure administration in both groups |
|
Primary |
Assessment of change of Forced Expiratory Volume |
Dynamic spirometry test was performed, assessing the forced expiratory volume in 1 s (FEV1) measured in liters. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. |
twice: before and immediately after procedure administration in both groups |
|
Primary |
Assessment of change of Maximum Voluntary Ventilation |
Dynamic spirometry test was performed, assessing the maximum voluntary ventilation (MVV) measured in liters per minute. The test was performed with PNEUMO® spirometer and PNEUMO 2005 software (abcMED). The subject was sitting with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, inhale and exhale as quickly and as deeply as possible for 15 s until you hear the 'stop' command. This cycle was performed at least 3 times obtaining 3 measurements according to the standard ERSATS 2005. |
twice: before and immediately after procedure administration in both groups |
|