<?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>IRCT2013011512134N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-20</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical Sciences , Loghman Hospital</primary_sponsor>
      <public_title>Is LMA applicable in cochlear implant?</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects and side effects of LMA and tracheal tube in children under general anesthesia for cochlear implantation.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: Patients are not aware of the details of the study but they do not know which patient is in which group. On the other hand, patients are mostly small children who are not familiar with anesthetic process.So we believe that both the parents and patients are blind about the study. All the parents would sign the consent.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: cochlear implant. Condition 2: Hearing Loss, Deafness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: airway management with Laryngeal Mask Airway (LMA) without laryngoscpy at induction. Intervention 2: Control group: airway management with tracheal tube after laryngoscopy with McGill blade at induction.</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>Kamran Mottaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Loghman Hospital, Makhsous St, Kamali St, Kargar Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13336-31151</zip>
        <telephone>+98 21 5542 4040</telephone>
        <email>k_mottaghi@sbmu.ac.ir; kmrnmtghi@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kamran Mottaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Loghman Hospital, Makhsous St, Kamali St, Kargar Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13336-31151</zip>
        <telephone>+98 21 5542 4040</telephone>
        <email>k_mottaghi@sbmu.ac.ir; kmrnmtghi@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion:  elective cochlear implant surgery; ASA class I,II; age between 3-17 year; parental consent.&#13;
&#13;
     Exclusion criteria: upper airway infection; finding of difficult airway.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>17 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z96.2</hc_code>
      <hc_code>H91.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>cochlear implant, Presence of otological and audiological implants</hc_keyword>
      <hc_keyword>Hearing Loss, Deafness</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: airway management with Laryngeal Mask Airway (LMA) without laryngoscpy at induction</i_keyword>
      <i_keyword>Control group: airway management with tracheal tube after laryngoscopy with McGill blade at induction</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Airway Pressure. Timepoint: 15 minutes. Method of measurement: mm Hg.</prim_outcome>
      <prim_outcome>End Tidal CO2. Timepoint: 15 minutes. Method of measurement: mm Hg, Capnography.</prim_outcome>
      <prim_outcome>Arterial O2 Saturation SaO2. Timepoint: 15 minutes. Method of measurement: percent (%), Pulseoximetry.</prim_outcome>
      <prim_outcome>Pulse Rate. Timepoint: 15 minutes. Method of measurement: Beat per Minute, Pulseoximetry, Electrocardiography.</prim_outcome>
      <prim_outcome>Sore throat. Timepoint: In Post Anesthesia Care Unit and 24 hours post operation. Method of measurement: Asking patients, Visual Analog Scale.</prim_outcome>
      <prim_outcome>Cough. Timepoint: In Post Anesthesia Care Unit and 24 hours post operation. Method of measurement: Observation, Absent or Present.</prim_outcome>
      <prim_outcome>Bronchospasm/Wheezing. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Physical Examination, Auscultation, Absent/Present.</prim_outcome>
      <prim_outcome>Laryngospasm/ Desaturation. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Physical Examination, Pulseoximetry, Absent/Present.</prim_outcome>
      <prim_outcome>Vomiting. Timepoint: In Post Anesthesia Care Unit. Method of measurement: Observation, Absent or Present.</prim_outcome>
      <prim_outcome>Cardiac Dysrhythmia. Timepoint: During Operation and in Post Anesthesia Care Unit. Method of measurement: Electrocardiogram, Absent/Present.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bleeding during surgery. Timepoint: 15 minutes. Method of measurement: Surgical field observation (grade 1 to 5).</sec_outcome>
      <sec_outcome>Surgeon's Satisfaction of surgical Field. Timepoint: 15 minutes. Method of measurement: Asking Surgeon ( grade 1 to 3 ).</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, Shahid Beheshti University of Medical Sciences , Loghman Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-16</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Tabnak St, Evin, Chamran Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
