<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02246946</url>
  </required_header>
  <id_info>
    <org_study_id>UNICID14</org_study_id>
    <nct_id>NCT02246946</nct_id>
  </id_info>
  <brief_title>Positive Airway Pressure on Pleural Effusion After Drainage</brief_title>
  <official_title>Efficacy of the Addition of Positive Airway Pressure to Conventional Chest Physiotherapy in the Time to Resolution of Pleural Effusion After Drainage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Cidade de Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Cidade de Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the addition of intermittent positive airway&#xD;
      pressure breathing (specific lung expansion technique) to conventional chest physiotherapy&#xD;
      chest drainage is effective to accelerate the reabsorption of pleural effusion and&#xD;
      consequently decrease the duration of chest tube drainage and respiratory system impairment.&#xD;
      These effects would decrease hospital stay lengths and the incidence of pulmonary&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of chest tube drainage</measure>
    <time_frame>All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest drainage</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spirometry</measure>
    <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</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral Oxygen Saturation</measure>
    <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</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary complications</measure>
    <time_frame>All patients will be followed for the duration of hospital stay, an expected average of 10 days</time_frame>
    <description>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%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>All patients will be followed for the duration of hospital stay, an expected average of 10 days</time_frame>
    <description>The number of days in the hospital after chest drainage until discharge will be counted for each patient</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Pleural Effusion</condition>
  <arm_group>
    <arm_group_label>Positive Airway Pressure group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Chest Physiotherapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Positive Airway Pressure</intervention_name>
    <description>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</description>
    <arm_group_label>Positive Airway Pressure group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Chest Physiotherapy</intervention_name>
    <description>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</description>
    <arm_group_label>Conventional Chest Physiotherapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
          -  presence of pleural effusion&#xD;
&#xD;
          -  have undergone chest drain for fewer than 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to the use of non-invasive equipment that generates positive airway&#xD;
             pressure (such as: intolerance, phobia, drowsiness, restlessness, confusion,&#xD;
             hemodynamic instability requiring vasopressor therapy, systolic blood pressure &lt; 90&#xD;
             mmHg, facial trauma, ineffective cough or inability to swallow, nausea or vomiting,&#xD;
             upper gastrointestinal bleeding, acute myocardial infarction within the last 48 hours,&#xD;
             pneumothorax or bullous emphysema)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adriana C Lunardi, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Cidade de Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elinaldo C Santos, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital das Clínicas Dr. Alberto Lima</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clínicas Dr. Alberto Lima</name>
      <address>
        <city>Macapá</city>
        <state>Amapá</state>
        <zip>68900073</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Cidade de Sao Paulo</investigator_affiliation>
    <investigator_full_name>Adriana Claudia Lunardi</investigator_full_name>
    <investigator_title>Professor on Master's and Doctoral Programs in Physical Therapy of Universidade Cidade de São Paulo</investigator_title>
  </responsible_party>
  <keyword>pleural effusion</keyword>
  <keyword>chest tube</keyword>
  <keyword>respiratory therapy</keyword>
  <keyword>intermittent positive-pressure breathing</keyword>
  <keyword>lung function</keyword>
  <keyword>pulmonary complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02246946
org study id: UNICID14
nct id: NCT02246946
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 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
description: 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
measure: 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
description: 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
measure: 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
description: 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.
measure: Pulmonary complications
time frame: All patients will be followed for the duration of hospital stay, an expected average of 10 days
description: 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%)
measure: Length of hospital stay
time frame: All patients will be followed for the duration of hospital stay, an expected average of 10 days
description: The number of days in the hospital after chest drainage until discharge will be counted for each patient
arm group label: Positive Airway Pressure group
arm group type: Experimental
description: 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.
arm group label: Conventional Chest Physiotherapy group
arm group type: Active Comparator
description: 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.
arm group label: Control group
arm group type: Placebo Comparator
description: 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.
intervention type: Device
intervention name: Positive Airway Pressure
description: 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
arm group label: Positive Airway Pressure group
intervention type: Other
intervention name: Conventional Chest Physiotherapy
description: 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
arm group label: Conventional Chest Physiotherapy group
intervention type: Procedure
intervention name: Control group
description: to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adriana C Lunardi, PhD
role: Study Director
affiliation: Universidade Cidade de Sao Paulo
last name: Elinaldo C Santos, MSc
role: Principal Investigator
affiliation: Hospital das Clínicas Dr. Alberto Lima
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Cidade de Sao Paulo
investigator full name: Adriana Claudia Lunardi
investigator title: Professor on Master's and Doctoral Programs in Physical Therapy of Universidade Cidade de São Paulo
mesh term: Pleural Effusion