<?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>IRCT20110513006465N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-14</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the efficacy of laryngeal mask Airway (LMA) compared to endotracheal tube (ETT) in thoracic and abdominal surgeries for under general anesthesia.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the efficacy of laryngeal mask Airway (LMA) compared to endotracheal tube (ETT) in thoracic and abdominal surgeries general anesthesia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46380</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a double-blind randomized clinical trial in which the number of patients is determined according to the sample size formula and using a simple randomization method, which uses a random number table for each patient. The code is given and patients are randomly assigned to two treatment groups, with random code selection, Blinding description: In this study, patients are not aware of the placement in the study groups, and the person who analyzes the information collected does not know the study groups and is given information in groups A and B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thoracic Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: LMA masks of suitable size 3, 4 or 5 as recommended by the manufacturer (manufactured by IranFormis) before surgery and once. LMA cuff slowly fills until sound Don't hear from Leak Cuff. The LMA cuff pressure is filled in by a pressure gauge of 30 to 40 cm. Intervention 2: اntervention group 2: Placement of an endotracheal tube size 7 or 7/5 for female patients and size7/5 or 8 for male patients according to the recommendation of the manufacturer (production of teb tolid company) before surgery and once. The cuff is filled up to 25 mm Hg.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Alireza Seyed Siamdoust</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>21th Str., Asadabadi Ave., Hazrate Fatemeh Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8877 1806</telephone>
        <email>alirezasiamdoust@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Alireza Seyed Siamdoust</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>21th Str., Asadabadi Ave., Hazrate Fatemeh Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8877 1806</telephone>
        <email>alirezasiamdoust@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>​ASA Physical Status Classification System 1 or 2
Patient satisfaction to participate in the study
Age range between 25 and 60 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction to participate in the study
Patients not fasting
Latex sensitivity
History of colds in the last 10 days</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G54.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Thoracic root disorders, not elsewhere classified</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 1: LMA masks of suitable size 3, 4 or 5 as recommended by the manufacturer (manufactured by IranFormis) before surgery and once. LMA cuff slowly fills until sound Don't hear from Leak Cuff. The LMA cuff pressure is filled in by a pressure gauge of 30 to 40 cm.</i_keyword>
      <i_keyword>اntervention group 2: Placement of an endotracheal tube size 7 or 7/5 for female patients and size7/5 or 8 for male patients according to the recommendation of the manufacturer (production of teb tolid company) before surgery and once. The cuff is filled up to 25 mm Hg.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Effects on airway after intubation in anesthesia. Timepoint: During surgery and after surgery. Method of measurement: checkup.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sore Throat. Timepoint: After surgery. Method of measurement: Examination.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-01</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
