<?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>IRCT20240925063165N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-23</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of ultrasound on pleural catheter placement</public_title>
      <acronym></acronym>
      <scientific_title>The effect of two different methods of pleural space catheter insertion on its consequences in critical care patients with and without ultrasound guidance: A clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80853</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After obtaining ethical approval and coordination with the head nurse and the intensive care unit officials, patients will be selected according to the inclusion criteria. Then, if they are conscious, the patient or their legal guardian will be spoken to and with informed written consent, the patients will be separated based on the random allocation method. In order to randomly allocate to the two experimental and control groups, a block randomization method with blocks of four was used. In this way, the experimental group was assigned to B and the control group to A, and in blocks of four with the letters A and B, six cases ABBA, AABB, ABAB, BABA,BBAA, BAAB were written on separate sheets of paper and dropped into a container. One of these sheets was randomly taken out of the container and the combination written on it was written down and that sheet was dropped into the container again. Since the sample size in this study is 68 patients, this operation was repeated seventeen times and each time the combination written on each sheet was recorded in the sequence of the combination written on the previous sheet. Then, each letter was assigned a number from one to sixty-eight in the order of the letters written down in a row, and each letter was placed in an envelope and its number was written on the envelope. Each time a patient was selected, one of these envelopes was opened in the order of the number written on the envelope, and it was determined whether the patient should be placed in the experimental or control group, Blinding description: In this study, patient blinding was implemented. This means that the patients were unaware of the treatment method (whether ultrasound-guided or non-ultrasound guided) they received. The anesthesiologist performing the catheter insertion was aware of the treatment assigned to each patient, but no bias influenced the execution of the procedure. Additionally, to avoid potential researcher bias, all clinical assessments and data collection were performed without knowledge of the treatment group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pleural effusion.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Without ultrasound guide. Intervention 2: Intervention group: With ultrasound guidance.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information available.Protecting patient privacy and ensuring the security of their medical information are among our primary priorities. Furthermore, in accordance with data protection laws and ethical guidelines, the release of these data could lead to breaches of patient privacy. Additionally, not sharing IPD is a practical decision due to the technical complexities and high costs associated with data processing and anonymization, as well as security considerations.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Fakhra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>General operation room, 2th floor, Baqiyatallah Al'Azam Hospital, after Sheikh Bahayi, Mulla Sadra Street, Vanak Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 81261</telephone>
        <email>z.fakhra28@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Fakhra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>General operation room, 2th floor, Baqiyatallah Al'Azam Hospital, after Sheikh Bahayi, Mulla Sadra Street, Vanak Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 81261</telephone>
        <email>z.fakhra28@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Intensive care unit admission
Presence of pleural effusion
Adult</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with clinical instability
Presence of coagulopathy
Infection of catheterization site
Patient's unconsent</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J91</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pleural effusion in conditions classified elsewhere</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>Control group: Without ultrasound guide</i_keyword>
      <i_keyword>Intervention group: With ultrasound guidance</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of fluid drainage from the pleural catheter. Timepoint: After catheter insertion. Method of measurement: The amount of fluid removed from the catheter.</prim_outcome>
      <prim_outcome>Bleeding. Timepoint: One day. Method of measurement: Number of sterile gauzes.</prim_outcome>
      <prim_outcome>Infection. Timepoint: One day after catheter insertion. Method of measurement: Positive pleural fluid culture after catheter insertion.</prim_outcome>
      <prim_outcome>Number of attempts. Timepoint: During catheter insertion. Method of measurement: Counting times.</prim_outcome>
      <prim_outcome>Pneumothorax. Timepoint: After catheter insertion. Method of measurement: Chest X ray.</prim_outcome>
      <prim_outcome>Length of stay in the ICU. Timepoint: From admission to discharge from ICU. Method of measurement: Counting the number of days.</prim_outcome>
      <prim_outcome>Duration of ventilator dependency. Timepoint: Time to wean from ventilator. Method of measurement: Counting days.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-03</approval_date>
        <contact_name>Ethics committee of Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiyatallah Al'Azam Hospital, after Sheikh Bahayi, Mulla Sadra Street, Vanak Squareanak Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
