<?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>IRCT2013042913179N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-04</date_registration>
      <primary_sponsor>Vice chancellor for research, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>prevention of ventilator associated pneumonia</public_title>
      <acronym></acronym>
      <scientific_title>Effect of intermittent subglottic secretions drainage combined with closed endotracheal suctioning in comparison with open endotracheal suctioning on incidence of ventilator associated pneumonia in intubated patients in  Al-Zahra hospital  intensive care units,Isfahan University of Medical Sciences.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13126</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Drainage of secretions around the endotracheal tube cuff was performed with inspiratory pause maneuver. The patient was blinded to intervention due to the anesthesia. Infectious disease specialist who was responsible for determining ventilator-associated pneumonia was blind  to the grouping. the researcher were aware of the grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ventilator Associated Pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: Interventions in the Intervention group consist of closed suction system, 72-hour for endotracheal suctioning and subglottic secretions drainage. Every 3 hour, after oral full suction, the cuff of the endotracheal tube was connected to a cuff pressure gauge manometer. Inspiratory hold with use of inspiratory pause key that embedded in ventilator was performed. This key can hold breathing for 7 seconds and hyperinflated the lungs, in 3 seconds of holding the key, endotracheal tube cuff was depleted and pressure of air that trapping in the lungs, causing secretions to be pushed into the oral cavity. Tracheal tube cuff inflated in 6th second and the pressure was adjusted between 25 and 30 cm H2O. Oral cavity was cleaned with frequent suctioning. This maneuver was applied every three hours and immediately before the closed suction. For a closed suction, a suction catheter package that is used for 72hr was used. After identifying that the patient needs to be suctioned, Suction was attached to the suction connector and negative pressure was set to 200 cm H2O. Catheter sent into the patient's airway and after suction, catheter was removed. Intervention 2: In the control group, open suctioning was performed in sterile method, and subglottic secretions drainage was not 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rahimeh safdari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>73461-81746</zip>
        <telephone>+98 31 1792 2941</telephone>
        <email>safdari@nm.mui.ac.irraha.safdari@yahoo.comsafdari8822@yahoo.com</email>
        <affiliation>Isfahan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmadreza Yazdannik</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673548</zip>
        <telephone>+98 31 1792 2941</telephone>
        <email>Yazdannik@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: Patients 18 to 60 years, mechanical ventilation more than 48 hr,free of pneumonia before intubation,&#13;
exclusion criteria:death before 48 hr, extubation before end of study, surgery during the study period.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postprocedural respiratory disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions in the Intervention group consist of closed suction system, 72-hour for endotracheal suctioning and subglottic secretions drainage. Every 3 hour, after oral full suction, the cuff of the endotracheal tube was connected to a cuff pressure gauge manometer. Inspiratory hold with use of inspiratory pause key that embedded in ventilator was performed. This key can hold breathing for 7 seconds and hyperinflated the lungs, in 3 seconds of holding the key, endotracheal tube cuff was depleted and pressure of air that trapping in the lungs, causing secretions to be pushed into the oral cavity. Tracheal tube cuff inflated in 6th second and the pressure was adjusted between 25 and 30 cm H2O. Oral cavity was cleaned with frequent suctioning. This maneuver was applied every three hours and immediately before the closed suction. For a closed suction, a suction catheter package that is used for 72hr was used. After identifying that the patient needs to be suctioned, Suction was attached to the suction connector and negative pressure was set to 200 cm H2O. Catheter sent into the patient's airway and after suction, catheter was removed.</i_keyword>
      <i_keyword>In the control group, open suctioning was performed in sterile method, and subglottic secretions drainage was not performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence of Ventilator Associated Pneumonia. Timepoint: Before intubation, day 1, day 2, day 3, day 4, day 5,. Method of measurement: Clinical Pulmonary Infection Score, CPIS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>2012-10-28</approval_date>
        <contact_name>Medical Ethics Committee of Isfahan university of medical science.</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib,Isfahan  Isfahan  Isfahan  Iran, Islamic Republic Of  461-81746 Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
