<?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>IRCT201202159025N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-04-12</date_registration>
      <primary_sponsor>Vice chancellor for research, Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of four ways for insertion of laryngeal mask</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of efficacy, ease and speed of  insertion and post operative complications of  classic laryngeal mask airway (C-LMA) using four different methods in elective surgeries under general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-02-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9649</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Cataract.</hc_freetext>
      <i_freetext>Intervention 1: 1st Method: Standard method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth from gap surface side. Then, the LMA is moved along the hard palate with the forefinger until a resistance is felt due to oropharynx and the cuff is expanded based on manometer and finally the leakage is checked. Intervention 2: 2nd Method: Lateral method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth as standard method in such a way that the entire cuff is located in mouth. Then, the cuff is rotated at 45 degree angle laterally in such a way that only tongue side is in contact with mask edge. Then, the forefinger and thumb is used to move it along the mouth until a resistance is felt. Finally, the mask is rotated 45 degree in opposite direction and located in middle position and the cuff is expanded based on manometer and leakage is checked. Intervention 3: 3rd Method: Rotational method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth with 180 degree angle (the mask gap is toward hard palate). Then, it is moved along the mouth until a resistance is felt. Finally, it is rotated 180 degree and fixed behind the larynx and the cuff is expanded based on manometer and leakage is checked, and the cuff is expanded based on manometer and leakage is checked. Intervention 4: 4th Method: Modified standard method: This method is similar to the standard method except for the mask is moved in its paths without using any fingers.</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>Masood Zangi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alavy Dormitory, 1st Alley, Mollasadra Street, Namazi Square</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7173646199</zip>
        <telephone>+98 71 1647 4670</telephone>
        <email>masoodzangi@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Mohammadreza Hadavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department office, Shahid Faghihi Hospital, Zand Avenue</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 71 1231 8072</telephone>
        <email>hadavimr@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Body Mass Index (BMI) ranging from 20 to 30; ASA I,II &#13;
&#13;
Exclusion Criteria: Upper respiratory tract infection; sore throat; COPD; patients with high risk of aspiration (e.g Diabetes, gasteroesophagial reflux, diaphragmatic hernia, operation for more than 2 hours, position except supine and lithotomy)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H25.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Senile incipient cataract</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1st Method: Standard method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth from gap surface side. Then, the LMA is moved along the hard palate with the forefinger until a resistance is felt due to oropharynx and the cuff is expanded based on manometer and finally the leakage is checked.</i_keyword>
      <i_keyword>2nd Method: Lateral method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth as standard method in such a way that the entire cuff is located in mouth. Then, the cuff is rotated at 45 degree angle laterally in such a way that only tongue side is in contact with mask edge. Then, the forefinger and thumb is used to move it along the mouth until a resistance is felt. Finally, the mask is rotated 45 degree in opposite direction and located in middle position and the cuff is expanded based on manometer and leakage is checked.</i_keyword>
      <i_keyword>3rd Method: Rotational method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth with 180 degree angle (the mask gap is toward hard palate). Then, it is moved along the mouth until a resistance is felt. Finally, it is rotated 180 degree and fixed behind the larynx and the cuff is expanded based on manometer and leakage is checked, and the cuff is expanded based on manometer and leakage is checked.</i_keyword>
      <i_keyword>4th Method: Modified standard method: This method is similar to the standard method except for the mask is moved in its paths without using any fingers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Laryngeal mask insertion time. Timepoint: During mask insertion, 1 and 6 hours later. Method of measurement: Chronometer.</prim_outcome>
      <prim_outcome>Successful laryngeal mask insertion. Timepoint: During mask insertion. Method of measurement: Incidence (Percentage).</prim_outcome>
      <prim_outcome>Complication of laryngeal mask insertion. Timepoint: During mask insertion, 1 and 6 hours later. Method of measurement: Incidence (Percentage).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Incidence of hoarseness. Timepoint: 1 and 6 hours after operation. Method of measurement: Incidence (Percentage).</sec_outcome>
      <sec_outcome>Incidence of sore throat. Timepoint: 1 and 6 hours after operation. Method of measurement: Incidence (Percentage).</sec_outcome>
      <sec_outcome>Incidence of neck pain. Timepoint: 1 and 6 hours after operation. Method of measurement: Incidence (Percentage).</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, Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-02-12</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee, 7th Floor, Shiraz University of Medical Sciences central building, Zand Avenue Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
