<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/NCT04446520</url>
  </required_header>
  <id_info>
    <org_study_id>P.T REC/012/001740</org_study_id>
    <nct_id>NCT04446520</nct_id>
  </id_info>
  <brief_title>Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery</brief_title>
  <official_title>Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Princess Nourah Bint Abdulrahman University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Purpose: This study will find out the effect of Autogenic drainage on the prevention of&#xD;
      pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper&#xD;
      abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients&#xD;
      will be divided into two groups, study group (A) include patients that receive first&#xD;
      traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and&#xD;
      splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional&#xD;
      physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: This study will find out the effect of Autogenic drainage on the prevention of&#xD;
      pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper&#xD;
      abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients&#xD;
      will be divided into two groups, study group (A) include patients that receive first&#xD;
      traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and&#xD;
      splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional&#xD;
      physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2020</start_date>
  <completion_date type="Actual">September 5, 2020</completion_date>
  <primary_completion_date type="Actual">August 28, 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>arterial blood gases</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>prevalence of post operative pulmonary complication (pneumonia, hypoxemia and atelectasis) and number of days staying in ICU</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>autogenic drainage and traditional physiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>autogenic drainage technique plus traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>autogenic drainage</intervention_name>
    <description>breathing control using expiratory airflow to mobilize secretions from smaller to larger airways. Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation in addition to traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)</description>
    <arm_group_label>autogenic drainage and traditional physiotherapy</arm_group_label>
    <arm_group_label>traditional physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age from 50 to 60 years&#xD;
&#xD;
          -  Patients undergoing elective upper abdominal surgery with an abdominal incision longer&#xD;
             than 5 cm that is above or extending above the umbilicus.&#xD;
&#xD;
          -  Non-smoker patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients developing cancer&#xD;
&#xD;
          -  Patients with rib fractures&#xD;
&#xD;
          -  Inability to comprehend and follow instructions.&#xD;
&#xD;
          -  Pre-existing obstructive sleep apnea&#xD;
&#xD;
          -  Current hospital patient for a separate episode of care.&#xD;
&#xD;
          -  Patients requiring esophageal surgery or organ transplant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mona Taha, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alaini</name>
      <address>
        <city>Cairo</city>
        <zip>11711</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mona Mohamed Taha</investigator_full_name>
    <investigator_title>ASSISTANT PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>Autogenic drainage</keyword>
  <keyword>blood gases</keyword>
  <keyword>Pneumonia,</keyword>
  <keyword>upper abdominal surgery</keyword>
  <keyword>Postoperative pulmonary Complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04446520
org study id: P.T REC/012/001740
nct id: NCT04446520
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose: This study will find out the effect of Autogenic drainage on the prevention of
      pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper
      abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients
      will be divided into two groups, study group (A) include patients that receive first
      traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and
      splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional
      physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)
Purpose: This study will find out the effect of Autogenic drainage on the prevention of
      pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper
      abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients
      will be divided into two groups, study group (A) include patients that receive first
      traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and
      splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional
      physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: arterial blood gases
time frame: 7 days
measure: prevalence of post operative pulmonary complication (pneumonia, hypoxemia and atelectasis) and number of days staying in ICU
time frame: 7 days
arm group label: autogenic drainage and traditional physiotherapy
arm group type: Experimental
description: autogenic drainage technique plus traditional physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)
arm group label: traditional physiotherapy
arm group type: Active Comparator
description: traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and splinted coughing)
intervention type: Procedure
intervention name: autogenic drainage
description: breathing control using expiratory airflow to mobilize secretions from smaller to larger airways. Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation in addition to traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)
arm group label: autogenic drainage and traditional physiotherapy
arm group label: traditional physiotherapy
criteria: 
gender: All
minimum age: 50 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mona Taha, PhD
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mona Mohamed Taha
investigator title: ASSISTANT PROFESSOR
mesh term: Postoperative Complications
sharing ipd: No