<?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>IRCT20140519017756N45</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-29</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Impact of adding bronchoscopic suction to the routine therapy of pneumonia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of the routine procedure and the routine procedure supplemented by bronchoscopic suctioning in treating ventilator-associated pneumonia in patients admitted to the surgical intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33254</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients who are eligible to participate will be assigned a code. Afterward, the participants will be allocated to the intervention group or the control group using the table of random numbers, Blinding description: In addition to the participants themselves who are unaware of the intervention they receive, data collector and data analyzer are also both blinded to the allocated groups.</study_design>
      <phase>1-2</phase>
      <hc_freetext>ventilator-associated pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: Control group (routine): Individuals undergo antibiotic therapy and closed suction using a 50-cc normal sterile saline on a daily basis. Intervention 2: Intervention group (bronchoscopic suction): Patients will undergo bronchoscopic suction every other day in addition to the treatment received by the control group.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Deidentified Individual Participant Data Set

When:
after the paper extracted from the study is published and for 6 months

To whom:
researchers

Conditions:
research purposes

Where to obtain:
email

How to obtain:
email to the corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Bayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari Ave.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 32233019</telephone>
        <email>Xenon1346@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Hasan Karbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari Ave.</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 3239 5600</telephone>
        <email>Xenon1346@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of ventilator-associated pneumonia after 48 hours of mechanical ventilation
Informed consent for participation in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Infliction with pneumonia before intubation or 48 hours before intubation
Antibiotic use before intubation
Suffering from diseases that reduce immunity level
Use of immunosuppressant drugs
Patients with neutropenia (less than or equal to 500 neutrophils per milliliter)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J12.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other viral pneumonia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group (routine): Individuals undergo antibiotic therapy and closed suction using a 50-cc normal sterile saline on a daily basis.</i_keyword>
      <i_keyword>Intervention group (bronchoscopic suction): Patients will undergo bronchoscopic suction every other day in addition to the treatment received by the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improvement status according to APACHI II criteria. Timepoint: daily. Method of measurement: APACHI II checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Temperature. Timepoint: every 3 hours daily for a maximum of 10 days. Method of measurement: thermometer.</sec_outcome>
      <sec_outcome>Number of blood leukocytes. Timepoint: on a daily basis. Method of measurement: laboratory results.</sec_outcome>
      <sec_outcome>Blood oxygenation status. Timepoint: on a daily basis. Method of measurement: arterial blood gas test.</sec_outcome>
      <sec_outcome>Tracheal aspirate culture. Timepoint: at baseline and on completion day of study. Method of measurement: laboratory results.</sec_outcome>
      <sec_outcome>Mortality. Timepoint: on a daily basis for 10 days. Method of measurement: observation.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-12</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Birjand University of Medical Sciences, Ayatollah Ghaffari Street Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
