<?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>IRCT2013081714377N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-10-26</date_registration>
      <primary_sponsor>Vice chancellor for research Lorestan  University of Medical Sciences</primary_sponsor>
      <public_title>The effect of positive end expiratory pressure on the incidence of pulmonary complications.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of positive end expiratory pressure, five and ten cm  H2O on the incidence of pulmonary complications in patients undergoing coronary artery bypass surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14045</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Patients as stratified block are randomly divided  into two groups of control and intervention. Because statistical specialists, patients and nurses are measuring variables of random assignment were not aware of the researcher is aware of the random assignment of subjects to be considered, therefore, double-blind study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery bypass  graft.</hc_freetext>
      <i_freetext>Intervention 1: If the patient is in control group، from  arrival to the Intensivel Care Unit to extubation time he will get the amount of 5 cm H2O of positive end expiratory pressure. Intervention 2: Patients in intervention group، if  hemodynamic status is not disrupted، will get for 4 hours an average of PEEP of 10 cm H2O and until extubation time، PEEP of 5 cm H2O will be received.</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>Behzad Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan  Medical Sciences</address>
        <city>khoramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6814993165</zip>
        <telephone>+98 66 1323 9704</telephone>
        <email>moradi_b90@yahoo.com   ; masoodmoradi58@yahoo.com</email>
        <affiliation>Lorestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hasan Teimouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan  Medical Sciences</address>
        <city>Khorram Abad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6814993165</zip>
        <telephone>+98 66 1420 6098</telephone>
        <email>moradi_b90@yahoo.com   ; masoodmoradi58@yahoo.com</email>
        <affiliation>Lorestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria in the study are: 1- patients  who are in the 30-80 age range. 2- Lack of ejection fraction (EF) less than 30% in preoperative angiography tab. 3- No history of chronic obstructive airway disease (COPD). 4-No previous history of open heart surgery. 5- No history of broken ribs and a chest tube investments. 6- Their operation is not urgent. 7- The level of consciousness (GCS) of patients is equivalent to fifteen.&#13;
 Exclusion criteria are : 1- Time of aortic clamping more than 100 minutes. 2- Time of heart - lung bypass more than 120 minutes. 3​​- Use of intra aortic balloon pump during and after surjery. 4- In case a patient needs ventilation protocol out of our research protocol should be excluded. 5- If a Sick has to be transferred to the operating room (OR) again. 6- If the patient is in intubation over 24 hours.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>125.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart disease (chronic) NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>If the patient is in control group، from  arrival to the Intensivel Care Unit to extubation time he will get the amount of 5 cm H2O of positive end expiratory pressure.</i_keyword>
      <i_keyword>Patients in intervention group، if  hemodynamic status is not disrupted، will get for 4 hours an average of PEEP of 10 cm H2O and until extubation time، PEEP of 5 cm H2O will be received.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bottle chest   drainage. Timepoint: When the chest tube take out. Method of measurement: According to the ranking of chest bottle.</prim_outcome>
      <prim_outcome>Pao2/Fio2 ، o2-sat ، Paco2. Timepoint: Start entering the Intensive Care Unit, one hour, four hours, six hours later, just before tracheal extubation, one hour tafter the tracheal extubation  , six hours after the tracheal extubation, and then twelve, twenty-four and forty-eight hours after tracheal extubation. Method of measurement: By arterial blood gas analyzers.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pneumothorax. Timepoint: Early entry into the Intensive Care Unit  , one hour after tracheal extubation , and 5-7 days after surgery. Method of measurement: By chest radiography.</sec_outcome>
      <sec_outcome>Pneumonia. Timepoint: Daily. Method of measurement: 1-The new infiltration in chest  x- ray، 2- leukocytosis over twelve thousand ، 3- fever over 38.3° C، 4- purulent sputum.</sec_outcome>
      <sec_outcome>Atelectasis. Timepoint: Early entry into the Intensive Care Unit  , one hour after tracheal extubation , and 5-7 days after surgery. Method of measurement: By chest radiography.</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 Lorestan  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-07-27</approval_date>
        <contact_name>Ethics committee of  Lorestan  University of Medical Sciences</contact_name>
        <contact_address>km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan  Medical Sciences Khorramabad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
