<?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>IRCT2016051927969N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-09</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Nose Disinfection with Chlorhexidine on Respiratory Infection</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of  Nose and Mouth Disinfection with Chlorhexidine on indicators of  respiratory infections in intubated  patients with mechanical ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22798</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, mouthwash (disinfection cheeks, gums, palate, tongue and teeth) every 8 hours  with 10 ml of ready solution of 0.2% chlorhexidine is performed by the applicator for 30 second. Also every 8 hours after oral antiseptic, anti-infectious of nasal anterior openings is performed  with 0.2% chlorhexidine solution by cotton swab. This continues until the end of the fifth day of mechanical ventilation. Intervention 2: In the control group, mouthwash (disinfection cheeks, gums, palate, tongue and teeth) every 8 hours  with 10 ml of ready solution of 0.2% chlorhexidine is performed by the applicator for 30 second. This continues until the end of the fifth day of mechanical ventilation. In this group  is not done disinfection of nose.</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>Mahdi Alimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qoreishi Building, Daneshgah St, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3366 1500</telephone>
        <email>alimim1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Sadat Manzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ibn-e Sina St,  Chaharah Doktora Crossing, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>nms.it[at]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: The satisfaction of patient's attendant to participate in the study; The patient's age is more than 18 years; The patient has endotracheal tube through the mouth; The patient has not nasogastric tube; Expecting mechanical ventilation for at least 48 hours; On arrival to the ICU lung infiltration on chest radiograph Does not exist; At least two of the three clinical criteria indicators of ventilator associated pneumonia (rectal temperature less than 35 or more than 38 degrees Celsius, leukocyte count of less than 4,000 or more than 12,000 per cubic millimeter of blood and purulent tracheal secretions) does not exist. Exclusion criteria:  desire to continue participation in the study; Allergic reaction to chlorhexidine; Clear aspiration; At least two of the three clinical criteria indicators of ventilator associated pneumonia exist in the first or second day of mechanical ventilation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pneumonia, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, mouthwash (disinfection cheeks, gums, palate, tongue and teeth) every 8 hours  with 10 ml of ready solution of 0.2% chlorhexidine is performed by the applicator for 30 second. Also every 8 hours after oral antiseptic, anti-infectious of nasal anterior openings is performed  with 0.2% chlorhexidine solution by cotton swab. This continues until the end of the fifth day of mechanical ventilation.</i_keyword>
      <i_keyword>In the control group, mouthwash (disinfection cheeks, gums, palate, tongue and teeth) every 8 hours  with 10 ml of ready solution of 0.2% chlorhexidine is performed by the applicator for 30 second. This continues until the end of the fifth day of mechanical ventilation. In this group  is not done disinfection of nose.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of  Body Temperature. Timepoint: up to Five Days after beginning of Intervention. Method of measurement: By Glass Thermometer for Axillary in Degrees Celsius.</prim_outcome>
      <prim_outcome>Amount of Tracheal secretions. Timepoint: up to Five Days after beginning of Intervention. Method of measurement: Based on The Required Frequency of Tracheal Suctioning.</prim_outcome>
      <prim_outcome>Kind of Tracheal secretions. Timepoint: up to Five Days after beginning of Intervention. Method of measurement: On the basis of color, odor and secretions concentration and according to the nurse caring for the patient.</prim_outcome>
      <prim_outcome>Amount of Blood leukocytes. Timepoint: up to Five Days after beginning of Intervention. Method of measurement: By blood test.</prim_outcome>
      <prim_outcome>Ratio of  Arterial Oxygenation. Timepoint: up to Five Days after beginning of Intervention. Method of measurement: By Analyze of Arterial Blood Gases.</prim_outcome>
      <prim_outcome>Changes of Chest radiographic. Timepoint: up to Five Days after beginning of Intervention. Method of measurement: By the removable radiological devices (portable).</prim_outcome>
      <prim_outcome>Culture of tracheal secretions. Timepoint: up to Five Days after beginning of Intervention. Method of measurement: Quantitative culture with Gram stain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ventilator associated Pneumonia. Timepoint: Up to five days after beginning of  intervention. Method of measurement: By Clinical Pulmonary Infection Score.</sec_outcome>
      <sec_outcome>The relationship between clinical criteria and diagnosis of pneumonia. Timepoint: Up to five days after beginning of  intervention. Method of measurement: By Clinical Pulmonary Infection Score.</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, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-07</approval_date>
        <contact_name>The ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Qoreishi Building, Daneshgah St, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
