<?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>IRCT20180709040402N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-28</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Infection Control Guidelines on Incidence of Ventilator-associated Pneumonia.</public_title>
      <acronym></acronym>
      <scientific_title>The  effect  of Infection Control Guidelines implementation on incidence of Ventilator-Associated Pneumonia in hospitalized patients in intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32845</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ventilator-associated Pneumonia (VAP).</hc_freetext>
      <i_freetext>Intervention 1: 1. semi recumbent position. 2. use of standard bed in ICU. 3. change of suction equipment (Catheter and tube). 4. use of close suction system. 5. oral intubation technique. 6. chest physiotherapy. 7. use of Heat and Moisture Exchanger (HME) filter. 8. ventilator circuit change. 9. hand washing. 10. Deep Venous Thrombosis prophylaxis. 11.peptic ulcer  prophylaxis. 12. use of chlorhexidine gluconate (0.2 or 0.12 percent) mouthwash. 13. subglottic secretion suction. 14.  set of Cuff pressure in endotracheal (ET) tubes in the range of 20–30 cm H2O. 15. elevation the head of the bed at 30 to 45 degrees, during and after gavage. Intervention 2: Routine care is performed in the control group and researcher does not intervene.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Study data can be shared after coding

When:
Start accessing the data three months after the publication of the article

To whom:
Academic and academic institutions

Conditions:
Citation to the results of the study, comparison with other studies is permitted. And any copying of results and data forms is impermissible.

Where to obtain:
Nursing and Midwifery Library, Faculty of Nursing, Jondishapoor University of Medical Sciences, Ahvaz, Iran. Safavi Ali Project Executive. 09188415182 ،Safaviali999@yahoo.com

How to obtain:
Three months after the publication of the article, dated 2019/04/02, emails or telephone data files will be available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Safavi Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safavi Karim  home, 3Shahed Alley ,15 South Khordad</address>
        <city>Abdanan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6971664145</zip>
        <telephone>+98 84 3362 3105</telephone>
        <email>Safavi.a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asadi Zakir Marzieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz, Jundishapur University of Medical Sciences,University of Ahvaz, School of Nursing and Midwifery</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794 - 61357</zip>
        <telephone>+98 61 3333 2368</telephone>
        <email>marziyehasadizaker@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients admitted to the intensive care unit.
Absence of pneumonia before entering the study.
Non-Cystic Fibrosis Patients, Pleural Empyema, acquired pneumonia from the community and Neutropenia.
did not have aspiration before admission
Length of hospitalization is less than 20 days
Endotracheal intubation and connected to ventilator</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Extropulmonary infection
Symptoms occur less than 48 hours after mechanical ventilation
Patients with incomplete file and clinical information</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ventilator-associated Pneumonia (VAP)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1. semi recumbent position. 2. use of standard bed in ICU. 3. change of suction equipment (Catheter and tube). 4. use of close suction system. 5. oral intubation technique. 6. chest physiotherapy. 7. use of Heat and Moisture Exchanger (HME) filter. 8. ventilator circuit change. 9. hand washing. 10. Deep Venous Thrombosis prophylaxis. 11.peptic ulcer  prophylaxis. 12. use of chlorhexidine gluconate (0.2 or 0.12 percent) mouthwash. 13. subglottic secretion suction. 14.  set of Cuff pressure in endotracheal (ET) tubes in the range of 20–30 cm H2O. 15. elevation the head of the bed at 30 to 45 degrees, during and after gavage.</i_keyword>
      <i_keyword>Routine care is performed in the control group and researcher does not intervene.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence of ventilator associated pneumonia. Timepoint: Before and after the intervention. Method of measurement: Use of modified Clinical Pulmonary Infection Score (mCPIS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The  amount of antibiotic use. Timepoint: before and after the intervention. Method of measurement: taking daily dose.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-08</approval_date>
        <contact_name>Ethics Committee of  Jundishapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>No.Golestan, Esfand St, Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
