<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/NCT04463303</url>
  </required_header>
  <id_info>
    <org_study_id>LULTRASOUND</org_study_id>
    <nct_id>NCT04463303</nct_id>
  </id_info>
  <brief_title>The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema</brief_title>
  <official_title>The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the work is to&#xD;
&#xD;
        1. Assess the incidence of weaning induced pulmonary adema(WIPO).&#xD;
&#xD;
        2. Assess the risk factors of WIPO.&#xD;
&#xD;
        3. Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing&#xD;
           trial(SBT).&#xD;
&#xD;
        4. Detect the threshold of B-line increase (Delta-B-lines) that provided the best&#xD;
           diagnostic accuracy of WIPO.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <description>patient who will develop weaning induced pulmonary adema</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <description>patient who will nor develop weaning induced pulmonary adema</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>lung ultrasound</intervention_name>
    <description>patient with or without weaning induced pulmonary adema</description>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_label>group 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include patients on mechanical ventilation who will be suitable for&#xD;
        spontaneous breathing trial (SBT).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study will include patients on mechanical ventilation who will be suitable for&#xD;
             spontaneous breathing trial (SBT).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with poor lung ultrasound window, history of cardiomyopathy, significant&#xD;
             valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic&#xD;
             and mitral stenosis) will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Dina Ali Ahmed</investigator_full_name>
    <investigator_title>Lecturer of Internal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Edema</mesh_term>
    <mesh_term>Disease</mesh_term>
    <mesh_term>Edema</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/NCT04463303
org study id: LULTRASOUND
nct id: NCT04463303
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the work is to

        1. Assess the incidence of weaning induced pulmonary adema(WIPO).

        2. Assess the risk factors of WIPO.

        3. Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing
           trial(SBT).

        4. Detect the threshold of B-line increase (Delta-B-lines) that provided the best
           diagnostic accuracy of WIPO.
observational model: Case-Control
time perspective: Cross-Sectional
measure: the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema
time frame: 1 year
arm group label: group 1
description: patient who will develop weaning induced pulmonary adema
arm group label: group 2
description: patient who will nor develop weaning induced pulmonary adema
intervention type: Other
intervention name: lung ultrasound
description: patient with or without weaning induced pulmonary adema
arm group label: group 1
arm group label: group 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 60 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Dina Ali Ahmed
investigator title: Lecturer of Internal Medicine
mesh term: Pulmonary Edema
mesh term: Disease
mesh term: Edema
sharing ipd: No