<?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>IRCT20220612055153N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-26</date_registration>
      <primary_sponsor>Bandare-abbas University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of endotracheal intubation and laryngeal mask on respiratory parameters</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of endotracheal airway intubation and laryngeal mask (LMA) methods on respiratory parameters in patients undergoing elective orthopedic sugery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64136</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to eliminate the bias caused by the patient's awareness or anesthesia assistant and evaluator of the results and its possible effect on the research result, the study is performed as a two-way blind and a random number table, Blinding description: Random allocation was performed based on Random allocation software and based on that, the even numbers of the table were considered for airway intubation and the odd numbers of the table were considered for laryngeal mask placement. The numbers were placed in sealed envelopes and by someone other than the procedure Returned and based on that the airway was managed by an anesthesia assistant.</study_design>
      <phase>3</phase>
      <hc_freetext>Orthopedic patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Establishment of airway through endotracheal tube. Intervention 2: Control group: Establishment of airway through laryngeal mask (LMA).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data can be shared

When:
After confirming the publication of the article

To whom:
All Researchers

Conditions:
Use data to complete clinical trial studies

Where to obtain:
Dr.Majid Vatankhah through email:m.vatankhah@hums.ac.ir

How to obtain:
After the investigation of researcher request and presentation of required documents will be accessible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Vatankhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jomhuri BLV</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791991551</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>m.vatankhah@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Vatankhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jomhuri Blvd, Shahid Mohammadi Hospital</address>
        <city>Bandar Abbas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791991551</zip>
        <telephone>+98 76 3334 5009</telephone>
        <email>m.vatankhah@hums.ac.ir</email>
        <affiliation>Bandare-abbas University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 18 to 70 years ASA I, II candidate for elective orthopedic surgery under general anesthesia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of COPD, asthma, ILD, and pulmonary fibrosis with active lung infection
EF fraction (less than ‌40%)
BMI &gt; ‌35 kg / m2
Emergency surgery
Airway malformation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Orthopedic aftercare</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: Establishment of airway through endotracheal tube</i_keyword>
      <i_keyword>Control group: Establishment of airway through laryngeal mask (LMA)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Investigation of respiratory parameters. Timepoint: Evaluation of respiratory parameters at 1, 3, 5, 10 and 15 minutes after airway establishment. Method of measurement: Measurement of arterial oxygen saturation percentage by pulse oximetry device and End-tidal carbon dioxide(Etco2) via capnograph.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Respiratory complications during surgary. Timepoint: Measurement of respiratory parameters such as blood oxygen saturation percentage (spo2) and end-tidal carbon dioxide (Etco2) at 1, 3, 5, 10 and 15 minutes after establishing airway. Method of measurement: Pulse oximetry and capnography device.</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>Bandare-abbas University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-13</approval_date>
        <contact_name>Ethics Commitee Of Hormozgan University Of Medical Sciences</contact_name>
        <contact_address>Jomhuri Blvd, Shahid Mohammadi Hospital Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
