<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/NCT04435535</url>
  </required_header>
  <id_info>
    <org_study_id>PEPpåtrack</org_study_id>
    <nct_id>NCT04435535</nct_id>
  </id_info>
  <brief_title>Chest Physiotherapy in Tracheotomized Patients</brief_title>
  <official_title>Immediate Effects of Chest Physiotherapy in Tracheotomized Patients With Acute Respiratory Distress Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Positive expiratory pressure (PEP) breathing is common for treatment of different lung&#xD;
      diseases and can increase lung volume and increase elimination of secretion from the airways.&#xD;
      Today there is no evidence whether the treatment is effective or not for patients in the&#xD;
      intensive care unit. The purpose of this study is to evaluate if PEP breathing can increase&#xD;
      oxygenation for patients in the intensive care unit during weaning from the ventilator after&#xD;
      acute respiratory distress syndrome.&#xD;
&#xD;
      PEP breathing will be applied on the tracheal cannula for 15 minutes. Measure of the PEP&#xD;
      effect will be done before, during and for 20 minutes after PEP breathing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Procedure:&#xD;
&#xD;
      To achieve steady state, all subjects are positioned in a semi-recumbent position (30°) for&#xD;
      60 minutes before the start of the intervention and remain in that position during the entire&#xD;
      investigation. Subjects are instructed to avoid talking and movements during both steady&#xD;
      state and measurements. Airway suctioning (up to 20 kPa) through the tracheal cannula is&#xD;
      performed only if there is risk for tube obstruction or if SpO2 decreases below 90%.&#xD;
      Frequency of airway suctioning, and number of coughs during the study time are registered. An&#xD;
      extra pre-intervention measurement is performed 15 minutes after the first to increase the&#xD;
      validity of baseline measurements and control for changes in measured variables due to&#xD;
      spontaneous variations.&#xD;
&#xD;
      A PEP device consisting of a one-way valve and exchangeable resistance nipples is used during&#xD;
      the PEP breathing treatment. The resistance nipple is chosen at the start of the intervention&#xD;
      aiming at an airway pressure of 10-15 cmH2O during tidal breathing (measured with a&#xD;
      calibrated manometer). The duration of the PEP treatment is 15 minutes. Complementary oxygen&#xD;
      is delivered at the same amount as before the intervention.&#xD;
&#xD;
      Measurements:&#xD;
&#xD;
      The primary outcome is PaO2. Five separate arterial blood samples of 0.7-1.5 ml each&#xD;
      (altogether 3.5-7.5 ml for each subject) are drawn from an existing arterial catheter in the&#xD;
      radial artery in the left or the right arm by nurses at the ward, and directly analysed.&#xD;
&#xD;
      Subject characteristics are registered from the clinical records, including gender, age, body&#xD;
      mass index (BMI), smoking history, duration of invasive ventilation, and length of ICU stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2012</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in PaO2</measure>
    <time_frame>Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.</time_frame>
    <description>Change from baseline arterial partial pressure of oxygen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PaCO2</measure>
    <time_frame>Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.</time_frame>
    <description>Change from baseline arterial partial pressure of carbon dioxide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peripheral oxygen saturation (SpO2)</measure>
    <time_frame>Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.</time_frame>
    <description>Change from baseline in SpO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory frequency</measure>
    <time_frame>Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.</time_frame>
    <description>Change from baseline in respiratory frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean arterial pressure (MAP)</measure>
    <time_frame>Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.</time_frame>
    <description>Change from baseline in MAP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate</measure>
    <time_frame>Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.</time_frame>
    <description>Change from baseline in heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Borg´s Category Ratio 10scale (Borg CR 10 scale) from baseline</measure>
    <time_frame>Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.</time_frame>
    <description>Borg CR-10 scale is an eleven point nominal scale that measures patient perceived breathlessness. A higher number indicates a greater breathlessness. 0=no breathlessness. 10 = very very high breathlessness (almost maximal).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Positive expiratory pressure (PEP)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>PEP 10 cmH2O 15 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PEP</intervention_name>
    <description>Positive expiratory pressure 10 cmH2O 15 min</description>
    <arm_group_label>Positive expiratory pressure (PEP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tracheostomized participants&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  Moderate or severe ARDS during the ICU period, according to the Berlin definition.&#xD;
&#xD;
          -  Ability to maintain PaO2 ≥ 67.5mmHg, with supplementary oxygen if needed, during&#xD;
             spontaneous breathing for at least three consecutive hours.&#xD;
&#xD;
          -  Normal curvature of the spine.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Jenny Örman</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Breathing exercises</keyword>
  <keyword>Intensive care</keyword>
  <keyword>Physical therapy modalities</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Respiratory distress syndrome, adult</keyword>
  <keyword>Ventilator weaning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT04435535
org study id: PEPpåtrack
nct id: NCT04435535
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Positive expiratory pressure (PEP) breathing is common for treatment of different lung
      diseases and can increase lung volume and increase elimination of secretion from the airways.
      Today there is no evidence whether the treatment is effective or not for patients in the
      intensive care unit. The purpose of this study is to evaluate if PEP breathing can increase
      oxygenation for patients in the intensive care unit during weaning from the ventilator after
      acute respiratory distress syndrome.

      PEP breathing will be applied on the tracheal cannula for 15 minutes. Measure of the PEP
      effect will be done before, during and for 20 minutes after PEP breathing.
Procedure:

      To achieve steady state, all subjects are positioned in a semi-recumbent position (30°) for
      60 minutes before the start of the intervention and remain in that position during the entire
      investigation. Subjects are instructed to avoid talking and movements during both steady
      state and measurements. Airway suctioning (up to 20 kPa) through the tracheal cannula is
      performed only if there is risk for tube obstruction or if SpO2 decreases below 90%.
      Frequency of airway suctioning, and number of coughs during the study time are registered. An
      extra pre-intervention measurement is performed 15 minutes after the first to increase the
      validity of baseline measurements and control for changes in measured variables due to
      spontaneous variations.

      A PEP device consisting of a one-way valve and exchangeable resistance nipples is used during
      the PEP breathing treatment. The resistance nipple is chosen at the start of the intervention
      aiming at an airway pressure of 10-15 cmH2O during tidal breathing (measured with a
      calibrated manometer). The duration of the PEP treatment is 15 minutes. Complementary oxygen
      is delivered at the same amount as before the intervention.

      Measurements:

      The primary outcome is PaO2. Five separate arterial blood samples of 0.7-1.5 ml each
      (altogether 3.5-7.5 ml for each subject) are drawn from an existing arterial catheter in the
      radial artery in the left or the right arm by nurses at the ward, and directly analysed.

      Subject characteristics are registered from the clinical records, including gender, age, body
      mass index (BMI), smoking history, duration of invasive ventilation, and length of ICU stay.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in PaO2
time frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
description: Change from baseline arterial partial pressure of oxygen
measure: Change in PaCO2
time frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
description: Change from baseline arterial partial pressure of carbon dioxide
measure: Change in peripheral oxygen saturation (SpO2)
time frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
description: Change from baseline in SpO2
measure: Change in respiratory frequency
time frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
description: Change from baseline in respiratory frequency
measure: Change in mean arterial pressure (MAP)
time frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
description: Change from baseline in MAP
measure: Change in heart rate
time frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
description: Change from baseline in heart rate
measure: Change in Borg´s Category Ratio 10scale (Borg CR 10 scale) from baseline
time frame: Baseline. At 7 minutes and 15 minutes of intervention and 20 minutes post intervention.
description: Borg CR-10 scale is an eleven point nominal scale that measures patient perceived breathlessness. A higher number indicates a greater breathlessness. 0=no breathlessness. 10 = very very high breathlessness (almost maximal).
arm group label: Positive expiratory pressure (PEP)
arm group type: Other
description: PEP 10 cmH2O 15 min
intervention type: Procedure
intervention name: PEP
description: Positive expiratory pressure 10 cmH2O 15 min
arm group label: Positive expiratory pressure (PEP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Jenny Örman
investigator title: Physiotherapist
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome