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| Name | Class |
|---|---|
| University of Modena and Reggio Emilia | OTHER |
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Mechanical devices to increase the individual's bronchial hygiene are commonly used in patients with chronic retention of secretions and abnormal cough reflex. In this clinical context a new technology (namely TPEP® - Temporary Positive Expiratory Pressure) has been recently developed with the aim to improve the respiratory condition in patients suffering from chronic respiratory diseases. This trial has the aim to assess the clinical efficacy of TPEP in patients with chronic hypersecretion and airways obstruction, but with a normal competence of the cough reflex
This is a single-blind multicentre controlled randomized trial with consecutive recruitment. Randomization list by blocks will be available. Group comparison will be made between active therapies including TPEP added to conventional MABT (Intervention) or MABT alone (Control). Active therapy will last 10 consecutive daily sessions in both groups.
Primary outcome
Efficacy comparison on change in:
a.arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)
Secondary outcomes
Efficacy comparison on change in:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | TPEP added to conventional manually assisted breathing techniques (MABT) |
|
| 2 | Active Comparator | Manually assisted breathing techniques (MABT) alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPEP device (UNIKO) | Device | This technique is mainly based on a continuous low-pressure insufflation in the airways, which is likely to reduce (or even avoid) the potential pressure-related damages of other commonly used devices. This device should be used only in those individuals who are showing a normal competence of their cough reflex, thus it should be considered as a means which may help those techniques normally adopted for the individual's bronchial hygiene. |
| Measure | Description | Time Frame |
|---|---|---|
| arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index) | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Sputum volume | Day 1 to 10 | |
| Sputum characteristics | Day 1 to 10 | |
| Individual's perceived sensation (VAS scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrico M. Clini, MD | University of Modena - Villa Pineta Hospital | Study Director |
| Nicolino Ambrosino, MD | AOU Pisana - Cisanello (Pisa) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Maugeri IRCCS | Lumezzane | Brescia | Italy | |||
| Villa Pineta Hospital |
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| ID | Term |
|---|---|
| D029481 | Bronchitis, Chronic |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| MABT (Manually assisted breathing techniques) | Procedure | Conventionally manually assisted breathing techniques |
|
|
| Day 1 to 10 |
| Lung function (volumes and respiratory muscle performance) | Day 1 - 3 - 10 |
| Pavullo nel Frignano |
| Modena |
| 41026 |
| Italy |
| Fondazione Maugeri IRCCS | Veruno | Novara | Italy |
| Centro Riabilitazione Auxilium Vitae | Volterra | Pisa | Italy |
| Ospedale San Raffaele IRCCS | Volterra | Roma | 00049 | Italy |
| Ospedale San Giuseppe - Riabilitazione Specialistica | Milan | 20100 | Italy |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |