<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/NCT03230617</url>
  </required_header>
  <id_info>
    <org_study_id>EDHMVCP</org_study_id>
    <nct_id>NCT03230617</nct_id>
  </id_info>
  <brief_title>Dynamic Hyperinflation In Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients</brief_title>
  <official_title>Evaluation Of Dynamic Hyperinflation In Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Chronic obstructive pulmonary disease is a common respiratory condition that is characterized&#xD;
      by inflammation of the large and small peripheral airways , the alveoli and adjacent&#xD;
      capillary networks. Severe airflow obstruction that imposes a significant load on the&#xD;
      respiratory system is a major manifestation of Chronic obstructive pulmonary disease. The&#xD;
      reduced expiratory airflow also causes air trapping at the end of expiration , producing&#xD;
      alveolar pressure that are higher than atmospheric pressure before the next breath. This&#xD;
      condition is intrinsic positive end-expiratory pressure .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The duration of mechanical ventilation</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Intrinsic positive end expiratory pressure &gt; 5</arm_group_label>
    <description>chronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure more than5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Auto positive end expiratory pressure &lt; 5</arm_group_label>
    <description>chronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure less than5</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mechanical ventilator</intervention_name>
    <description>Mechanical ventilation, in the healthcare setting or home, helps patients breathe by assisting the inhalation of oxygen into the lungs and the exhalation of carbon dioxide. Depending on the patient's condition, mechanical ventilation can help support or completely control breathing.</description>
    <arm_group_label>Auto positive end expiratory pressure &lt; 5</arm_group_label>
    <arm_group_label>Intrinsic positive end expiratory pressure &gt; 5</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patient who diagnosed as chronic obstructive pulmonary disease admitted to the&#xD;
        respiratory intensive care unit, chest department, Assiut university hospital, who are&#xD;
        mechanically ventilated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with acute exacerbation of Chronic obstructive pulmonary disease and&#xD;
             respiratory failure who are intubated and mechanically ventilated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with neuromuscular diseases.&#xD;
&#xD;
          -  patient with pulmonary vascular diseases e.g pulmonary embolism.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Suzan Salama, MSc</last_name>
    <phone>0101423616</phone>
    <email>Suzansalama61@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aliae Abd Rabou, MD</last_name>
    <phone>01222302352</phone>
    <email>aliaehussein@Gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Nisreen Marghany Taha, MD</last_name>
      <phone>01019293548</phone>
      <email>Nisreen.new@Gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Reddy VG. Auto-PEEP: how to detect and how to prevent--a review. Middle East J Anaesthesiol. 2005 Jun;18(2):293-312.</citation>
    <PMID>16438005</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Nisreen Mtk</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03230617
org study id: EDHMVCP
nct id: NCT03230617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic obstructive pulmonary disease is a common respiratory condition that is characterized
      by inflammation of the large and small peripheral airways , the alveoli and adjacent
      capillary networks. Severe airflow obstruction that imposes a significant load on the
      respiratory system is a major manifestation of Chronic obstructive pulmonary disease. The
      reduced expiratory airflow also causes air trapping at the end of expiration , producing
      alveolar pressure that are higher than atmospheric pressure before the next breath. This
      condition is intrinsic positive end-expiratory pressure .
observational model: Other
time perspective: Cross-Sectional
measure: The duration of mechanical ventilation
time frame: 1 month
arm group label: Intrinsic positive end expiratory pressure > 5
description: chronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure more than5
arm group label: Auto positive end expiratory pressure < 5
description: chronic obstructive pulmonary disease patient with intrinsic positive end expiratory pressure less than5
intervention type: Device
intervention name: Mechanical ventilator
description: Mechanical ventilation, in the healthcare setting or home, helps patients breathe by assisting the inhalation of oxygen into the lungs and the exhalation of carbon dioxide. Depending on the patient's condition, mechanical ventilation can help support or completely control breathing.
arm group label: Auto positive end expiratory pressure < 5
arm group label: Intrinsic positive end expiratory pressure > 5
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Suzan Salama, MSc
phone: 0101423616
email: Suzansalama61@yahoo.com
last name: Aliae Abd Rabou, MD
phone: 01222302352
email: aliaehussein@Gmail.com
facility: 
contact: 
country: Egypt
citation: Reddy VG. Auto-PEEP: how to detect and how to prevent--a review. Middle East J Anaesthesiol. 2005 Jun;18(2):293-312.
PMID: 16438005
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Nisreen Mtk
investigator title: principal investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive