<?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>IRCT20170516033992N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-28</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of laryngeal mask insertion in pediatric airway management</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of standard and reverse methods of laryngeal  mask airway insertion in pediatric airway managment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50730</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization took place in a way that numbers from 1 to 68 were written separately and put inside a blinded box. For each patient a piece of paper was drawn out. If the number drawn for the patient was even it went to group A and if it was an odd number, patients were attributed to group B, Blinding description: The condition of the study was explained to patients but they weren't told which group they were categorized into. Other than our patients everyone in the patient care team including the doctor, research team, and analyzing and supervising team were informed about the intervention of each patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Inguinal hernia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Putting the mask upside down (Holding LMA from the proximal part, the mask was put inversely on the hard palate and was lead into the hypopharynx. then with a rotation of 180-degree counterclockwise, it was lead to the pharynx. Intervention 2: Control group: standard laryngeal mask insertion (LMA mask was taken out completely and like holding a pen in the hand it was put inside the mouth and with pressing the index finger, it is lead toward the hard palate, pharynx and larynx.</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 a need for coordination with the center of dissemination</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tohid Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No30., Jahad Sq., Resalat st., Uremia University of Medical Sciences, Uremia, Iran</address>
        <city>Uremia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715833631</zip>
        <telephone>+98 44 3193 7000</telephone>
        <email>karami.tohid@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tohid Karami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No30., Jahad Sq., Resalat st., Uremia University of Medical Sciences, Uremia, Iran</address>
        <city>Uremia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715833631</zip>
        <telephone>+98 44 3193 7000</telephone>
        <email>karami.tohid@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>elective herniorrhaphy candidates with ASA1 and ASA2
Given permission to participate in the study</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>ASA3 and higher patients
patients who require urgent surgery required with the risk of aspiration from the stomach fluids
patients with full stomach and therefore with higher risk of aspiration of fluids</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inguinal hernia</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: Putting the mask upside down (Holding LMA from the proximal part, the mask was put inversely on the hard palate and was lead into the hypopharynx. then with a rotation of 180-degree counterclockwise, it was lead to the pharynx.</i_keyword>
      <i_keyword>Control group: standard laryngeal mask insertion (LMA mask was taken out completely and like holding a pen in the hand it was put inside the mouth and with pressing the index finger, it is lead toward the hard palate, pharynx and larynx.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chest movement. Timepoint: Through anesthesia procedure in the operation room. Method of measurement: Observation (No movement, Partially good, Adequately good).</prim_outcome>
      <prim_outcome>Airway pressure. Timepoint: Through anesthesia procedure  in the operation room. Method of measurement: Adjustable Pressure Limiting results.</prim_outcome>
      <prim_outcome>Time of Laryngeal mask insertion. Timepoint: Through anesthesia procedure in the operation room. Method of measurement: Clock.</prim_outcome>
      <prim_outcome>Mucous damage. Timepoint: After extracting the mask. Method of measurement: presence of blood on the mask.</prim_outcome>
      <prim_outcome>Times tried to put the laryngeal mask on. Timepoint: In time of getting the mask. Method of measurement: Observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chest movement. Timepoint: Through anesthesia procedure in the operation room. Method of measurement: Observation (no movement, partially good, adequately enough).</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-19</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>No30., Jahad Sq., Resalat St., Urmia University of Medical Sciences, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
