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Positive Airway Pressure on Pleural Effusion After Drainage

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ClinicalTrials.gov Identifier: NCT02246946
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : January 18, 2017
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Adriana Claudia Lunardi, Universidade Cidade de Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Device: Positive Airway Pressure Other: Conventional Chest Physiotherapy Procedure: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the Addition of Positive Airway Pressure to Conventional Chest Physiotherapy in the Time to Resolution of Pleural Effusion After Drainage
Study Start Date : December 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Positive Airway Pressure group
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
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

Active Comparator: Conventional Chest Physiotherapy group

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
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

Placebo Comparator: Control group

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
to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide




Primary Outcome Measures :
  1. Duration of chest tube drainage [ Time Frame: All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest 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


Secondary Outcome Measures :
  1. Spirometry [ Time Frame: 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 ]
    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

  2. Peripheral Oxygen Saturation [ Time Frame: 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 ]
    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.

  3. Pulmonary complications [ Time Frame: All patients will be followed for the duration of hospital stay, an expected average of 10 days ]
    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%)

  4. Length of hospital stay [ Time Frame: All patients will be followed for the duration of hospital stay, an expected average of 10 days ]
    The number of days in the hospital after chest drainage until discharge will be counted for each patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246946


Locations
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Brazil
Hospital das Clínicas Dr. Alberto Lima
Macapá, Amapá, Brazil, 68900073
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Study Director: Adriana C Lunardi, PhD Universidade Cidade de Sao Paulo
Principal Investigator: Elinaldo C Santos, MSc Hospital das Clínicas Dr. Alberto Lima

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adriana Claudia Lunardi, Professor on Master's and Doctoral Programs in Physical Therapy of Universidade Cidade de São Paulo, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT02246946     History of Changes
Other Study ID Numbers: UNICID14
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by Adriana Claudia Lunardi, Universidade Cidade de Sao Paulo:
pleural effusion
chest tube
respiratory therapy
intermittent positive-pressure breathing
lung function
pulmonary complications
Additional relevant MeSH terms:
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Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases