<?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>IRCT2013092414756N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-17</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciencse- research assisstance</primary_sponsor>
      <public_title>Effect of mechanical ventilation on hemodynamic</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Airway Pressure Release Ventilation on patient' hemodynamic after Coronary Artery Bypass Graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-11-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14289</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention of this research is a ventilation mode is called Airway Pressure Release Ventilation that applied through ventilator and tracheal tube for half an hour. this mode is a inverse ratio mode that patient airway pressure between high pressure and low pressure is fluctuated.in this intervention, the duration of high pressure is 4.5 sec and duration of low pressure is 0.5 sec.The high-level pressure based on the patient's tidal volume required is determined. Intervention 2: This study is a cross-over study and no control group. Intervention (APRV mode) compared with SIMV mode. synchronized intermittent mandatory ventilation is a usual mode of mechanical ventilation in research environment.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Background and purpose: Following coronary artery bypass grafting (CABG) respiratory failure is inevitable, therefore, invasive ventilation is used in patients. This study was conducted to investigate the effect of airway pressure release ventilation (APRV) on arterial blood gas (ABG) of patients after CABG.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Materials and methods: This study was conducted in 32 patients in Mashhad Imam Reza Hospital, 2014. The patients were randomly divided into two groups (n= 16 per group). The two groups received synchronized intermittent mandatory ventilation (SIMV). Then the patients in group I were switched to APRV while in group II SIMV continued for another half an hour. Afterwards, group I received SIMV and group II received APRV for half an hour. In all three stages the values for ABG were recorded. Data was then analyzed in SPSS.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Results: The mean values of PaCO2 showed no significant changes in three stages between the two groups (P&gt;0.05) but the mean values of PaO2 in APRV stage in first group (P&lt; 0.001 and P&lt; 0.01) and second group (P&lt; 0.003 and P&lt; 0.002) showed significant increases compared to that of the first and second SIMV mode.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Conclusion: APRV led to improvement of oxygenation.&lt;br /&gt;&#13;
Keywords: continuous positive airway pressure, blood gas analysis, Coronary Artery Bypass Grafting            </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>Javad Malekzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad Nursing &amp; Midwifery School-West  Ebn-e-Sina Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 5511</telephone>
        <email>malekzadehj@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahram Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Ebn-e-Sina Street. Emem Reza hospital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3802 2322</telephone>
        <email>aminish@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 40-70 years old; hemodynamic stability in the first visit; EF ≥ 40% ; RASS = -2 to -3; surgery OFF PUMP; CABG without repair or replace the valve; failure to perform CPR during surgery or before the study; failure to perform emergency surgery (out of routine preoperative); absence of underlying lung disease;  lack of oxygenation and ventilation disorder; having hypertension before surgery.&#13;
Exclusion criteria: CPR performed during study; the need to replace volume; -2&lt; RASS &lt;-3; bleeding more than 100ml / hr of Drains; need to have surgery again; pH arterial &lt;7.25; dysrhythmia that lead to the development of hemodynamic changes.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention of this research is a ventilation mode is called Airway Pressure Release Ventilation that applied through ventilator and tracheal tube for half an hour. this mode is a inverse ratio mode that patient airway pressure between high pressure and low pressure is fluctuated.in this intervention, the duration of high pressure is 4.5 sec and duration of low pressure is 0.5 sec.The high-level pressure based on the patient's tidal volume required is determined.</i_keyword>
      <i_keyword>This study is a cross-over study and no control group. Intervention (APRV mode) compared with SIMV mode. synchronized intermittent mandatory ventilation is a usual mode of mechanical ventilation in research environment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac index. Timepoint: before intervention, half an hour after intervention &amp;  half an hour after return to base mode. Method of measurement: lit/min/BSA.</prim_outcome>
      <prim_outcome>Stroke volume index. Timepoint: before intervention, half an hour after intervention &amp;  half an hour after return to base mode. Method of measurement: mi/BSA.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: before intervention, half an hour after intervention &amp;  half an hour after return to base mode. Method of measurement: mmHg.</prim_outcome>
      <prim_outcome>Systemic vascular resistance. Timepoint: before intervention, half an hour after intervention &amp;  half an hour after return to base mode. Method of measurement: Dynes‏/‏sec‏/‏cm5‎.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Arterial oxygen saturation. Timepoint: before intervention, half an hour after intervention &amp; half an hour after return to basic mode. Method of measurement: percent.</sec_outcome>
      <sec_outcome>Ratio ofl arterial oxygen to inspired oxygen fraction. Timepoint: before intervention, half an hour after intervention &amp; half an hour after return to basic mode. Method of measurement: number.</sec_outcome>
      <sec_outcome>Pressure of arterial co2. Timepoint: before intervention, half an hour after intervention &amp; half an hour after return to basic mode. Method of measurement: mmHg.</sec_outcome>
      <sec_outcome>Pressure of arterial oxygen. Timepoint: before intervention, half an hour after intervention &amp; half an hour after return to basic mode. Method of measurement: mmHg.</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>Mashhad University of Medical Sciencse- research assisstance</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-04</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Street. Qureshi building Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
