Positive Airway Pressure on Pleural Effusion After Drainage

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of the Addition of Positive Airway Pressure to Conventional Chest Physiotherapy in the Time to Resolution of Pleural Effusion After Drainage

Conditions
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Pleural Effusion

Intervention / Treatment
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* Device: Positive Airway Pressure
* Other: Conventional Chest Physiotherapy
* Procedure: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years presence of pleural effusion have undergone chest drain for fewer than 24 hours Exclusion Criteria: contraindication to the use of non-invasive equipment that generates positive airway pressure (such as: intolerance, phobia, drowsiness, restlessness, confusion, hemodynamic instability requiring vasopressor therapy, systolic blood pressure < 90 mmHg, facial trauma, ineffective cough or inability to swallow, nausea or vomiting, upper gastrointestinal bleeding, acute myocardial infarction within the last 48 hours, pneumothorax or bullous emphysema)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Airway Pressure group<br>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. | Device: Positive Airway Pressure<br>* 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<br>|
| Active Comparator: Conventional Chest Physiotherapy group<br>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. | Other: Conventional Chest Physiotherapy<br>* 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<br>|
| Placebo Comparator: Control group<br>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. | Procedure: Control group<br>* to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pleural effusion, chest tube, respiratory therapy, intermittent positive-pressure breathing, lung function, pulmonary complications