<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20231105059962N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-09</date_registration>
      <primary_sponsor>Sahiwal medical college Sahiwal</primary_sponsor>
      <public_title>Effect of different chest drain size in management of malignant pleural effusion</public_title>
      <acronym></acronym>
      <scientific_title>SMALL BORE CATHETER VERSUS WIDE BORE CHEST TUBE IN THE MANAGEMENT OF MALIGNANT PLEURAL EFFUSION</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73590</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: - Simple method of randomization.
- Unit of randomization is individual or patient.
- A table of random numbers to be used for randomization.
- Random sequence to be built by Microsoft Excel.
- Allocation concealment was not carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Malignant pleural effusion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group one will include eight patients with histology proved malignant pleural effusion. They will be intubated with a small bore chest catheter for symptomatic management and upon adequate drainage of pleural fluid for pleurodesis. Catheter will be kept in place until adequate drainage of the effusion. Aim is to define the patient outcomes in terms of duration of chest drain and hospitalization. Intervention 2: Intervention group:  Intervention group two will include eight patients with histology proved malignant pleural effusion. They will be intubated with large bore chest tubes for symptomatic management and upon adequate drainage of pleural fluid for pleurodesis. Chest tube will be kept in place until adequate drainage of the effusion. Aim is to define the patient outcomes in terms of duration of chest drain and hospitalization.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmed Uzair</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>TB ward Sahiwal teaching Hospital Sahiwal</address>
        <city>Sahiwal</city>
        <country1>Pakistan</country1>
        <zip>57000</zip>
        <telephone>+92 312 6114878</telephone>
        <email>rollno225@gmail.com</email>
        <affiliation>Sahiwal medical college and allied teaching hospital Sahiwal</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmed Uzair</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>TB ward Sahiwal teaching hospital Sahiwal</address>
        <city>Sahiwal</city>
        <country1>Pakistan</country1>
        <zip>57000</zip>
        <telephone>+92 312 6114878</telephone>
        <email>rollno225@gmail.com</email>
        <affiliation>Sahiwal medical college and allied teaching hospital Sahiwal</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Malignant pleural effusion</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Hydropneumothorax
Pneumothorax
Empyema thoracis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C78.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Secondary malignant neoplasm of pleura</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group one will include eight patients with histology proved malignant pleural effusion. They will be intubated with a small bore chest catheter for symptomatic management and upon adequate drainage of pleural fluid for pleurodesis. Catheter will be kept in place until adequate drainage of the effusion. Aim is to define the patient outcomes in terms of duration of chest drain and hospitalization.</i_keyword>
      <i_keyword>Intervention group:  Intervention group two will include eight patients with histology proved malignant pleural effusion. They will be intubated with large bore chest tubes for symptomatic management and upon adequate drainage of pleural fluid for pleurodesis. Chest tube will be kept in place until adequate drainage of the effusion. Aim is to define the patient outcomes in terms of duration of chest drain and hospitalization.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of chest drain and hospitalization. Timepoint: After the intervention until the improvement of clinical symptoms. Method of measurement: Clinical assessment and radiology.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain during the course of intubation. Timepoint: After the intervention until removal of chest drain. Method of measurement: 1-10 pain scoring by the patient.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Sahiwal medical college Sahiwal</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-01</approval_date>
        <contact_name>Ethics committee of Sahiwal medical college, STH and allied teaching hospitals, Sahiwal-57000, Pakis</contact_name>
        <contact_address>Sahiwal medical college, college road, Sahiwal. Sahiwal Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
