Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Incidence of adverse events |
Incidence of adverse events in the treatment period and during the subsequent follow-up, directly correlated with the lower airways cleaning treatments under investigation |
Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) until the following 4 weeks |
|
Secondary |
Time needed for attainment of a stabilized effective pulmonary ventilation |
Number of days needed to attain the stabilization of an effective pulmonary ventilation, as confirmed simultaneously by all the following examinations: chest auscultation, ABG (for respiratory exchanges efficiency), spirometry (in particular: Forced Expiratory Flow 75% [FEF 75], for pulmonary patency), chest X-ray and chest ultrasound. |
Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) |
|
Secondary |
Recurrence of lower airways obstruction |
Incidence of recurrence of lower airways obstructions requiring retreatment with the lower airways treatments under investigation, in the study period following the attainment of stabilized effective pulmonary ventilation |
From the attainment of stabilized effective pulmonary ventilation until 3 months later |
|
Secondary |
Incidence of infections of lower respiratory airways |
Incidence of acute infections of the lower respiratory airways, throughout the study period. |
Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) and through the following 3 months |
|
Secondary |
Incidence of sepsis |
Incidence of sepsis related to acute infections of the lower respiratory airways, throughout the study period |
Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) and through the following 3 months |
|
Secondary |
Time needed for weaning from mechanical ventilation, from its start |
Number of days needed to wean from mechanical ventilation, starting from the mechanical ventilation starting date (also if previously occurred in a sending hospital) |
From mechanical ventilation start date until mechanical ventilation end date (up to 1 year) |
|
Secondary |
Time needed for weaning from mechanical ventilation, from hospital admission |
Number of days needed to wean from mechanical ventilation, starting from the date of admission to the Montecatone R.I. hospital |
From admission date to Montecatone R.I. until mechanical ventilation end date (up to 1 year) |
|
Secondary |
Evaluation of cognitive performance: attention and memory - 1 |
Neuropsychological test: Preliminary Neuropsychological Battery |
Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation |
|
Secondary |
Evaluation of cognitive performance: attention and memory - 2 |
Neuropsychological test: Verbal Span |
Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation |
|
Secondary |
Evaluation of cognitive performance: attention and memory - 3 |
Neuropsychological test: Immediate Visual Memory |
Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation |
|
Secondary |
Evaluation of cognitive performance: attention and memory - 4 |
Neuropsychological test: Digit Symbol Substitution test |
Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation |
|
Secondary |
Evaluation of cognitive performance: logical and executive functions - 1 |
Neuropsychological test: Verbal Fluency |
Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation |
|
Secondary |
Evaluation of cognitive performance: logical and executive functions - 2 |
Neuropsychological test: Progressive Matrices |
Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation |
|
Secondary |
Evaluation of cognitive performance: logical and executive functions - 3 |
Neuropsychological test: Verbal Analogies |
Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation |
|
Secondary |
Evaluation of cognitive performance: social cognition |
Neuropsychological test: Eyes Test |
3 months after the day of attainment of stabilized effective pulmonary ventilation |
|
Secondary |
Costs of the T-PEP and IPV treatments - 1 |
Average costs of equipments used in the overall number of sessions with T-PEP or IPV treatments, needed to attain stabilized effective pulmonary ventilation |
Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) |
|
Secondary |
Costs of the T-PEP and IPV treatments - 2 |
Average costs of consumables used in the overall number of sessions with T-PEP or IPV treatments, needed to attain stabilized effective pulmonary ventilation |
Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) |
|