<?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>IRCT2014101919584N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-30</date_registration>
      <primary_sponsor>Vice chancellor for research, Isfahan university of medical sciences</primary_sponsor>
      <public_title>Using different modes of ventilation after coronary artery bypass graft surgery</public_title>
      <acronym></acronym>
      <scientific_title>Determining and comparing the effect of Adaptive Support Ventilation and Synchronized Intermittent Mandatory Ventilation on respiratory support outcomes after Coronary Artery Bypass Graft surgery, Isfahan University of Medical sciences, Chamran hospital, 2014</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17500</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>Atherosclerotic heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Description: In this study, patients after undergoing Coronary Artery Bypass Graft surgery (CABG) and transferring to the intensive care unit (ICU) while intubated, with approval of an anesthesiologist for posibility of using one of the Adaptive Support Ventilation (ASV) or Synchronized Intermittent Mandatory Ventilation (SIMV) modes, were randomized to the intervention or control group.&#13;
 &#13;
Intervention group: using Adaptive Support Ventilation mode for respiratory ventilation after coronary artery bypass graft surgery in intensive care unit. Intervention 2: Control group: Using Synchronized  Intermittent Mandatory Ventilation mode for respiratory ventilation after coronary artery bypass graft surgery in intensive care unit.</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>Hadi Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan university of medical sciences, faculty of nursing and midwifery, Hezar Jarib street, Azadi square, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 2901</telephone>
        <email>hadi.zarei767@gmail.com</email>
        <affiliation>Isfahan university of medical sciences, faculty of nursing and midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and midwifery, Isfahan university of medical sciences, Hezar Jarib street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3791 2901</telephone>
        <email>hadi.zarei767@gmail.com</email>
        <affiliation>Isfahan university of medical sciences, faculty of nursing and midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Main inclusion criteria: Using one of the ventilation modes (Adaptive support ventilation (ASV) or synchronized intermittent mandatory ventilation (SIMV)) on Raphael ventilator was allowed by anesthesiologist; The range of age was between 25 and 65 years; Patients did not have a history of lung diseases (Asthma, ...) or lung and heart surgeries; Patients did not have renal failure (serum creatinine more than 2), liver disease, and history of seizure and CVA; left ventricular ejection fraction was more than 30 percent; In the time of ICU entrance patients were haemodynamically stable ( respiratory rate less than 35 per minute, heart rate less than 150 per minute, mean atrial pressure less than 70 mmHg) and intra aortic balloon pump was not used.&#13;
&#13;
Main exclusion criteria: occurring unstable haemodynamic status during research (respiratory rate more than 35 per minute, heart rate more than 150 per minute, mean atrial pressure more than 70 mmHg); life threatening arrhythmia durin research like ventricular tachycardia; need to excess dosages of inotropes and vasoconstrictors during research (Dopamin more than 20 milligram per hour, norepinephrin more than 0.5 milligram per hour, dobotamin more than 25 milligram per hour, and epinephrin with any doses); Unusual bleeding after operation (chest tube drainage more than 500 ml per hour, more than 350 ml per hour for 2 hours, or more than 1000 ml at all) ; Need to anesthesia and operation again.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>IX125.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Description: In this study, patients after undergoing Coronary Artery Bypass Graft surgery (CABG) and transferring to the intensive care unit (ICU) while intubated, with approval of an anesthesiologist for posibility of using one of the Adaptive Support Ventilation (ASV) or Synchronized Intermittent Mandatory Ventilation (SIMV) modes, were randomized to the intervention or control group.&#13;
 &#13;
Intervention group: using Adaptive Support Ventilation mode for respiratory ventilation after coronary artery bypass graft surgery in intensive care unit</i_keyword>
      <i_keyword>Control group: Using Synchronized  Intermittent Mandatory Ventilation mode for respiratory ventilation after coronary artery bypass graft surgery in intensive care unit</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intubation duration. Timepoint: When the intervention starts. Method of measurement: Hour and minutes.</prim_outcome>
      <prim_outcome>Length of hospital stay. Timepoint: When the patient is being discharged. Method of measurement: Hour and minutes.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nothing. Timepoint: nothing. Method of measurement: nothing.</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, Isfahan university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-08</approval_date>
        <contact_name>Moral committee of Isfahan university of medical sciences</contact_name>
        <contact_address>Isfahan university of medical sciences, Azadi squre, Hezar Jarib street, Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
