<?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>IRCT2016091726858N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-08</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of using supraglottic airway and classic laryngeal mask among children underwent surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of using supraglottic airway and classic laryngeal mask among children underwent surgery with general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22154</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: hernia. Condition 2: hydrocele.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in the proper depth of anesthesia, appropriate size of supraglottic airway based on the child weight and the manufacturer's instructions will be selected and placed by an anesthesiologist with experience in placement of supraglottic equipment. Intervention 2: Control group: in the proper depth of anesthesia, appropriate size of classic laryngeal mask based on the child weight and the manufacturer's instructions will be selected and placed by an anesthesiologist with experience in placement of supraglottic equipment.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatihe Kerman Saravi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Mashahir Square</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816913396</zip>
        <telephone>+98 54 3341 1415</telephone>
        <email>f_kermansaravi@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Shahram Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza hospital, Emam Reza square, Ebne Sina street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3802 2314</telephone>
        <email>aminish@mums.ac.ir</email>
        <affiliation>Mashhad university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: the age of six months to six years; elective hernia or hydrocele surgery in supine position; no respiratory diseases and airway problems; no obstructive sleep apnea; no regurgitation; non-emergency surgery; no history of surgery on the abdomen and chest and BMI less than 30.&#13;
Exclusion criteria: problems during surgery; problems during tracheal intubation and prolonged surgery (more than one hour).</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K40,K40.0,</hc_code>
      <hc_code>N43.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inguinal hernia, Bilateral inguinal hernia, with obstruction, without gangrene, Bilateral inguinal hernia, with gangrene, Bilateral inguinal hernia, without obstruction or gangrene, Unilateral or unspecified inguinal hernia, with obstruction, without gang</hc_keyword>
      <hc_keyword>hydrocele of spermatic cord, testis or tunica vaginalis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in the proper depth of anesthesia, appropriate size of supraglottic airway based on the child weight and the manufacturer's instructions will be selected and placed by an anesthesiologist with experience in placement of supraglottic equipment.</i_keyword>
      <i_keyword>Control group: in the proper depth of anesthesia, appropriate size of classic laryngeal mask based on the child weight and the manufacturer's instructions will be selected and placed by an anesthesiologist with experience in placement of supraglottic equipment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximum airway pressure. Timepoint: Intraoperative. Method of measurement: Ventilator.</prim_outcome>
      <prim_outcome>Blood on equipment. Timepoint: Intraoperative. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Sore Throat. Timepoint: Postoperative. Method of measurement: Interviews with patients.</prim_outcome>
      <prim_outcome>End-Tidal CO2. Timepoint: Intraoperative. Method of measurement: Ventilator.</prim_outcome>
      <prim_outcome>Cough. Timepoint: Postoperative. Method of measurement: Observation and interviews with patients.</prim_outcome>
      <prim_outcome>Nausea. Timepoint: Postoperative. Method of measurement: Interviews with patients.</prim_outcome>
      <prim_outcome>Vomit. Timepoint: Postoperative. Method of measurement: Interviews with patients.</prim_outcome>
      <prim_outcome>Shortness of breath. Timepoint: Postoperative. Method of measurement: Interviews with patients.</prim_outcome>
      <prim_outcome>Dysphagia. Timepoint: Postoperative. Method of measurement: Interviews with patients.</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>Vice chancellor for research, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-27</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ghorayshi Building, Daneshgah Street, Mashhad University of Medical Sciences Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
