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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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The purpose of this study is to determine if the addition of intermittent positive airway pressure breathing (specific lung expansion technique) to conventional chest physiotherapy chest drainage is effective to accelerate the reabsorption of pleural effusion and consequently decrease the duration of chest tube drainage and respiratory system impairment. These effects would decrease hospital stay lengths and the incidence of pulmonary complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Airway Pressure group | Experimental | The patients allocated to this group will undergo bronchial hygiene treatments administered with a high-frequency oscillator for 5 sets of 10 repetitions, lung expansion exercises using flow oriented incentive spirometry for 5 sets of 20 repetitions and walking for 100 meters (i.e., the same treatment that will be administered to the Conventional Chest Physiotherapy group). Additionally, this group will receive positive airway pressure breathing with 15 mmHg by a device via a rubber facial mask for 30 minutes in a sitting position. |
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| Conventional Chest Physiotherapy group | Active Comparator | In the sitting position, the patients allocated to this group will undergo bronchial hygiene treatments administered with a high-frequency oscillator for 5 sets of 10 repetitions, lung expansion exercises using flow oriented incentive spirometry for 5 sets of 20 repetitions and positive airway pressure breathing with 4 mmHg via a rubber facial mask for 5 minutes in a sitting position. These patients will also walk for 100 meters. The use of positive pressure breathing with 4 mmHg has no therapeutic value, but will help keep the blinding of assessors by the presence of the equipment in the room and mark the patient's skin. |
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| Control group | Placebo Comparator | The patients allocated to this group will receive positive airway pressure breathing with 4 mmHg (without therapeutic value) via a rubber facial mask for 30 minutes in a sitting position. The use of positive pressure breathing with 4 mmHg has no therapeutic value, but will help keep the blinding of assessors by the presence of the complete kit of equipment in the room. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure | Device | To this group, Intermittent Positive Airway Pressure Breathing with 15 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of chest tube drainage | The criteria for the removal the chest drain will an output of transudative fluid over 24h ≤ 200 ml and full lung expansion on chest radiography | All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest drainage |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry | The blind assessor will use a portable spirometer according previously established implementation and acceptability criteria. The following variables will be considered: forced vital capacity, forced expiratory volume in the 1st second, and forced expiratory flow between 25% and 75% of the curve. The predictive values for the Brazilian population will be used | On the 4th and 8th days after the beginning of the intervention protocol. Or on the day of hospital discharge if it occurs prior to the 8th day of protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana C Lunardi, PhD | Universidade Cidade de Sao Paulo | Study Director |
| Elinaldo C Santos, MSc | Hospital das Clínicas Dr. Alberto Lima | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas Dr. Alberto Lima | Macapá | Amapá | 68900073 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31843426 | Derived | Dos Santos EDC, da Silva JS, de Assis Filho MTT, Vidal MB, Monte MC, Lunardi AC. Adding positive airway pressure to mobilisation and respiratory techniques hastens pleural drainage: a randomised trial. J Physiother. 2020 Jan;66(1):19-26. doi: 10.1016/j.jphys.2019.11.006. Epub 2019 Dec 13. | |
| 25744852 | Derived |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Conventional Chest Physiotherapy | Other | To this group, routine physiotherapy exercises will be conducted plus Intermittent Positive Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide |
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| Control group | Procedure | to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide |
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| Peripheral Oxygen Saturation | The patients will be required to breath room air (without supplemental oxygen) for at least 10 minutes prior to the assessments. The blind assessor will use a portable pulse oximeter. | On the 4th and 8th days after the beginning of the intervention protocol. Or on the day of hospital discharge if it occurs prior to the 8th day of protocol |
| Pulmonary complications | The occurrence of the following complications will be monitored until the day of hospital discharge by a physician blinded to the intervention groups: pneumonia (chest radiography with pulmonary infiltrate associated with two of the following signs: purulent expectoration, temperature above 38.3°C and a greater than 25% increase in baseline leukocyte count with hyperthermia); atelectasis (RX associated with abnormal chest acute respiratory symptoms); and hypoxemia (peripheral oxygen saturation associated with respiratory symptoms below 85%) | All patients will be followed for the duration of hospital stay, an expected average of 10 days |
| Length of hospital stay | The number of days in the hospital after chest drainage until discharge will be counted for each patient | All patients will be followed for the duration of hospital stay, an expected average of 10 days |
| da Conceicao Dos Santos E, Lunardi AC. Efficacy of the addition of positive airway pressure to conventional chest physiotherapy in resolution of pleural effusion after drainage: protocol for a randomised controlled trial. J Physiother. 2015 Apr;61(2):93. doi: 10.1016/j.jphys.2014.11.016. Epub 2015 Mar 3. |
| D008722 | Methods |