<?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>IRCT20161220031487N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-14</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of anesthesia monitoring on trachea extubation</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the Trachea extubation in the operation room in open heart surgery with cardiopulmonary bypass using various anesthesia monitoring</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28683</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization using excel software and random number assignment with concealment of allocation, Blinding description: Patients are unaware of the group they are allocated.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Ischaemic heart diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: trachea extubation in the operation room- The nature of this intervention is the use of short-acting drugs and multiple anesthetic monitoring, and muscle and cardiovascular relaxation in patients with open heart surgery with cardiopulmonary bypass, in order to maintain adequate depth of anesthesia and maintain stable hemodynamics. At the end of the anesthesia, with neutralizing the effect of medications and maintaining the adequate analgesia and hemodynamic stability, and to ensure adequate surgical homeostasis, the patient is extubated in the operation room and transferred to the ICU. Intervention 2: Control group: extubation in the intensive care unit- The patient receives the usual anesthetic, and after transfer to the intensive care unit, the condition of the tracheal tube is sustained until the hemodynamic stability, and mechanical ventilation is performed.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ziya Totonchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niyayesh Exp., Valiasr cross.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416771818</zip>
        <telephone>+98 21 2392 4714</telephone>
        <email>ziy149@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ziae Totonchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Niyayesh Exp., Valiasr cross.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416771818</zip>
        <telephone>+98 21 2392 4714</telephone>
        <email>ziya189@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidate for elective coronary artery bypass grafting operation
Body mass index of 18-25 kg/m2
LVEF&gt;35%</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receiving inotropes for hemodynamics support before operation
Needing reoperation due to surgery-related complications such as bleeding
Not cooperating in the early post-operative days
Myocardial Infarction in the 7 recent days
Emphysema
Needing reoperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20-I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: trachea extubation in the operation room- The nature of this intervention is the use of short-acting drugs and multiple anesthetic monitoring, and muscle and cardiovascular relaxation in patients with open heart surgery with cardiopulmonary bypass, in order to maintain adequate depth of anesthesia and maintain stable hemodynamics. At the end of the anesthesia, with neutralizing the effect of medications and maintaining the adequate analgesia and hemodynamic stability, and to ensure adequate surgical homeostasis, the patient is extubated in the operation room and transferred to the ICU.</i_keyword>
      <i_keyword>Control group: extubation in the intensive care unit- The patient receives the usual anesthetic, and after transfer to the intensive care unit, the condition of the tracheal tube is sustained until the hemodynamic stability, and mechanical ventilation is performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Intensive care unit entrance. Method of measurement: Barometer and vital sign monitoring device.</prim_outcome>
      <prim_outcome>Use of anesthetics. Timepoint: During operation. Method of measurement: Calculating and registering the amount of the medication used.</prim_outcome>
      <prim_outcome>Using inotropes. Timepoint: In operation room and in ICU. Method of measurement: Calculating and registering the amount of medication used.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Intensive care unit entrance. Method of measurement: Barometer and vital sign monitoring device.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Intensive care unit entrance. Method of measurement: Vital sign monitoring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Arterial blood gas analysis. Timepoint: Before anesthesia induction and on intensive care unit entrance. Method of measurement: Blood gas analysis 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-05</approval_date>
        <contact_name>Ethics committee of the Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat highway, next to Milad Tower Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
