<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/NCT04420663</url>
  </required_header>
  <id_info>
    <org_study_id>ASHassaballaMD</org_study_id>
    <nct_id>NCT04420663</nct_id>
  </id_info>
  <brief_title>Pleural Manometry in Thoracocentesis</brief_title>
  <official_title>Pleural Manometry During Thoracocentesis in Patients With Malignant Pleural Effusion: How Much Fluid Should we Drain?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aly Sherif Hassaballa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      The study aiming to measure the pleural pressure during thoracocentesis in patients with&#xD;
      pleural effusion and the value of their measurement in both diagnostic and therapeutic&#xD;
      decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective controlled trial study will be performed between July 2019 and December&#xD;
      2020. the investigators will enroll patients with large volume pleural effusion referred to&#xD;
      our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform&#xD;
      therapeutic thoracentesis. All the patients will sign an informed consent for pleural&#xD;
      pressure monitoring during and after therapeutic thoracentesis.&#xD;
&#xD;
      The study aiming to measure the pleural pressure during thoracocentesis in patients with&#xD;
      pleural effusion and the value of their measurement in both diagnostic and therapeutic&#xD;
      decisions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>
    <intervention_model_description>This prospective controlled trial study will be performed between August 2019 and August 2020. We will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the pleural pressure</measure>
    <time_frame>Continous monitoring during the whole session of thoracocentesis</time_frame>
    <description>To measure the pleural pressure(mmHg) during thoracocentesis in patients with pleural effusion using a simple water pleural manometer</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Thoracocentesis of Pleural Effusion</condition>
  <arm_group>
    <arm_group_label>Manometer Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapeutic thoracentesis will be performed in a sitting position. wide bore catheter as a pleural catheter will be inserted into the pleural cavity. simple water manometer will be connected to the pleural catheter via 3-way adapter.connected to the infusion lines with one draining into the drainage collection bottle and the other pre-flushed with normal saline hanging down till 40 cm below the puncture site and then rising up (forming a &quot;U&quot;) with the ascending arm taped to the IV stand. baseline pleural pressure will be registered before the beginning of pleural fluid withdrawal. Pleural pressure curve will subsequently be registered after the withdrawal of each 200 ml of pleural fluid up to a total volume of 1000 ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Therapeutic thoracentesis will be performed in a sitting position. The skin will be cleaned with betadine antiseptic solution. Pleural aspiration should take place in a clean area using full aseptic techniques. 5-10 cc Lidocaine 2% will be given as local anesthetic in the site of puncture. the IV cannula is advanced till fluid is aspirated. Then, the needle is withdrawn and the catheter is fixed to two 3-way adapters fixed in series placed in between. connected to the infusion lines with one draining into the drainage collection bottle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pleural Manometry</intervention_name>
    <description>Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.</description>
    <arm_group_label>Manometer Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 18 and 85 years,&#xD;
&#xD;
          2. pleural effusion occupying at least one-third of the ipsilateral hemithorax in P-A&#xD;
             chest radiograph (CXR)&#xD;
&#xD;
          3. no contraindications for therapeutic thoracentesis&#xD;
&#xD;
          4. general health condition allowing prolonged procedure of therapeutic thoracentesis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with very small amounts of pleural effusion&#xD;
&#xD;
          -  patients on mechanical ventilation&#xD;
&#xD;
          -  patients using anticoagulant therapy&#xD;
&#xD;
          -  patients refusing to be subjected to thoracocentesis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiothoracic Surgery Hospital, Faculty of Medicine, Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>April 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Aly Sherif Hassaballa</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</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/NCT04420663
org study id: ASHassaballaMD
nct id: NCT04420663
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aiming to measure the pleural pressure during thoracocentesis in patients with
      pleural effusion and the value of their measurement in both diagnostic and therapeutic
      decisions.
This prospective controlled trial study will be performed between July 2019 and December
      2020. the investigators will enroll patients with large volume pleural effusion referred to
      our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform
      therapeutic thoracentesis. All the patients will sign an informed consent for pleural
      pressure monitoring during and after therapeutic thoracentesis.

      The study aiming to measure the pleural pressure during thoracocentesis in patients with
      pleural effusion and the value of their measurement in both diagnostic and therapeutic
      decisions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This prospective controlled trial study will be performed between August 2019 and August 2020. We will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.
primary purpose: Diagnostic
masking: None (Open Label)
measure: the pleural pressure
time frame: Continous monitoring during the whole session of thoracocentesis
description: To measure the pleural pressure(mmHg) during thoracocentesis in patients with pleural effusion using a simple water pleural manometer
arm group label: Manometer Group
arm group type: Experimental
description: Therapeutic thoracentesis will be performed in a sitting position. wide bore catheter as a pleural catheter will be inserted into the pleural cavity. simple water manometer will be connected to the pleural catheter via 3-way adapter.connected to the infusion lines with one draining into the drainage collection bottle and the other pre-flushed with normal saline hanging down till 40 cm below the puncture site and then rising up (forming a "U") with the ascending arm taped to the IV stand. baseline pleural pressure will be registered before the beginning of pleural fluid withdrawal. Pleural pressure curve will subsequently be registered after the withdrawal of each 200 ml of pleural fluid up to a total volume of 1000 ml.
arm group label: Conventional Group
arm group type: No Intervention
description: Therapeutic thoracentesis will be performed in a sitting position. The skin will be cleaned with betadine antiseptic solution. Pleural aspiration should take place in a clean area using full aseptic techniques. 5-10 cc Lidocaine 2% will be given as local anesthetic in the site of puncture. the IV cannula is advanced till fluid is aspirated. Then, the needle is withdrawn and the catheter is fixed to two 3-way adapters fixed in series placed in between. connected to the infusion lines with one draining into the drainage collection bottle.
intervention type: Diagnostic Test
intervention name: Pleural Manometry
description: Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.
arm group label: Manometer Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Aly Sherif Hassaballa
investigator title: Clinical Professor
mesh term: Pleural Effusion
sharing ipd: No