<?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>IRCT201305236318N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-06-17</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of hydrogen peroxide oral rinse on incidence of Ventilator-Associated Pneumonia in hospitalized patient in critical care unit</public_title>
      <acronym></acronym>
      <scientific_title>Effect of hydrogen peroxide oral rinse on incidence of Ventilator-Associated Pneumonia in hospitalized patient in critical care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6769</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ventilator-Associated Pneumonia.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group, after washing hands and elevation of bed's head and with wear of clear gloves, endo-tracheal tube cuff pressure reached to 25 centimeter of water and then by using of 4–6 swabs that soaked in 15 ml hydrogen peroxide solution 3%  Mucous membrane of the mouth, tongue and gums is washed and then additional secretions is suctioned. Patients' mouthwashes are doing twice a day in 8 am and 4 pm for 5 days. Intervention 2: In control  group, after washing hands and elevation of bed's head and with wear of clear gloves, endo-tracheal tube cuff pressure reached to 25 centimeter of water and then by using of 4–6 swabs that soaked in 15 ml saline normal 0.9%  Mucous membrane of the mouth, tongue and gums is washed and then additional secretions is suctioned. Patients' mouthwashes are doing twice a day in 8 am and 4 pm for 5 days.</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>Monir Nobahar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan,  University of Medical Sciencesl, Nursing and Paramedical University</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>35131338111</zip>
        <telephone>+98 23 1335 4170</telephone>
        <email>nobahar43@sem-ums.ac.ir nobahar43@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciencesl</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Monir Nobahar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan, University of Medical Sciences, Nursing and Paramedical University</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 1335 4170</telephone>
        <email>nobahar43@sem-ums.ac.ir nobahar43@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: more than 18 years old, under mechanical ventilation for more than 48 hours, no signs of aspiration, no pneumonia, no contraindications to oral care, lack of oral trauma, no contraindication to elevation of head of bed at least 30 degrees. Exclusion criteria: if a patient separated from mechanical ventilation for less than 48 hours.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j69.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pneumonitis due to food and vomit</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group, after washing hands and elevation of bed's head and with wear of clear gloves, endo-tracheal tube cuff pressure reached to 25 centimeter of water and then by using of 4–6 swabs that soaked in 15 ml hydrogen peroxide solution 3%  Mucous membrane of the mouth, tongue and gums is washed and then additional secretions is suctioned. Patients' mouthwashes are doing twice a day in 8 am and 4 pm for 5 days.</i_keyword>
      <i_keyword>In control  group, after washing hands and elevation of bed's head and with wear of clear gloves, endo-tracheal tube cuff pressure reached to 25 centimeter of water and then by using of 4–6 swabs that soaked in 15 ml saline normal 0.9%  Mucous membrane of the mouth, tongue and gums is washed and then additional secretions is suctioned. Patients' mouthwashes are doing twice a day in 8 am and 4 pm for 5 days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ventilator-Associated Pneumonia. Timepoint: In 1th and 5th days. Method of measurement: The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure (Pao2) to inspired oxygen fraction (Fio2) and chest x ray diagnose pneumonia.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ventilator-Associated Pneumonia. Timepoint: In 1th and 5th days. Method of measurement: The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure (Pao2) to inspired oxygen fraction (Fio2) and chest x ray diagnose pneumonia.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-22</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Basij Bulvar, Semnan Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
