<?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>IRCT20180213038720N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-18</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>A survey of the effect of ozonated water mouthwash on oral health and incidence of ventilator-associated pneumonia in patients connected to mechanical ventilation</public_title>
      <acronym></acronym>
      <scientific_title>A survey of the effect of ozonated water mouthwash on oral health and incidence of ventilator-associated pneumonia in patients connected to mechanical ventilation in intensive care units - A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41951</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is planned to be performed using quadruple-block random allocation method to conduct experiments in two groups using chlorhexidine and ozonated water as mouthwash. The patients will be included in the study and grouped under either of the two groups using SNOSE (Sequentially
numbered, sealed, opaque envelopes) allocation concealment and the designed quadruple blocks by a statistics expert, Blinding description: For the purpose of this study, the blinding will be performed as follows. Firstly, the resident at the ICU will group each patient under either of the two groups (chlorhexidine and ozonated water) using the designed quadruple blocks by a statistics expert. Next, trained nurses will administer, according to the respective protocol, the patients with the respective mouthwash without even knowing the type of the mouthwash. In the next stage, the researcher will undertake the mouth and teeth health inspection to see whether the ventilator-associated pneumonia (VAP) has occurred without no information on the grouping of the patients. Finally, once collected, the data will be analyzed by the statistics expert with no information about the group to which each patient belongs.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: ventilator-associated pneumonia. Condition 2: oral health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Firstly, inner surface of the mouth is thoroughly washed using a soft brush (for kids) on which 0.5 cm of fluoride-rich toothpaste is applied followed by a suction stage. Next, 15 mL of the ozonated water solution is used to wash all the surfaces across the entire mouth, lounge, and teeth using a sterilized syringe. After 30 seconds, the patient’s mouth is subjected to suction at a pressure of -100 mmHg for a maximum of 10 seconds followed by hyper-oxygenating the patient with 100% oxygen for 2 minutes. Intervention 2: Control group: Firstly, inner surface of the mouth is thoroughly washed using a soft brush (for kids) on which 0.5 cm of fluoride-rich toothpaste is applied followed by a suction stage. Next, 15 mL of the chlorhexidine 0.2 solution is used to wash all the surfaces across the entire mouth, lounge, and teeth using a sterilized syringe. After 30 seconds, the patient’s mouth is subjected to suction at a pressure of -100 mmHg for a maximum of 10 seconds followed by hyper-oxygenating the patient with 100% oxygen for 2 minutes.</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:
Collected data will be given to the individuals or organizations -a raw information- that will be provided with the consent of the participants without any name, address or telephone number, and other items.

When:
After we have finished the study if data crashed or disposed it will be reachable in a raw information.

To whom:
Just those have a Written request from authoritative research organizations.

Conditions:
If there was need to be called in analysis field you can call 09116470641.

Where to obtain:
Mostafa Soodmand, phone number: 09116470641

How to obtain:
After confirmation the requeste, only raw and unidentifiable information from the mail will be delivered within one week.

Comments:
If you have any question about this study call these numbers.
 09116470641- 09155328439</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa Soodmand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Student Ave, Shahid Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 5056</telephone>
        <email>msudmand@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morteza Izadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mulla Sadra Ave, after Sheikh Bahayi Ave, Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8805 0435</telephone>
        <email>morteza_izadi@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Availability of tracheal tube and connecting to the mechanical ventilation machine within no more than 24 hours from the intubation of the patient and connection to the machine.
No oral wounds or injuries
No engagement with immunosuppressive diseases
No record or symptoms of aspiration
No coagulation abnormalities
No dentures
No engagement with the asthma
No allergy and nose/mouth inflammation
No record of radiotherapy treatment
No use of antibiotic mouthwash during the past two months
No pregnancy
NO symptoms of pulmonary infection</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>any allergic response to brushing, Toothpaste and any of the mouthwashes
the patient’s first-order relative(s) dissatisfaction with the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J67.7</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Air conditioner and humidifier lung</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Firstly, inner surface of the mouth is thoroughly washed using a soft brush (for kids) on which 0.5 cm of fluoride-rich toothpaste is applied followed by a suction stage. Next, 15 mL of the ozonated water solution is used to wash all the surfaces across the entire mouth, lounge, and teeth using a sterilized syringe. After 30 seconds, the patient’s mouth is subjected to suction at a pressure of -100 mmHg for a maximum of 10 seconds followed by hyper-oxygenating the patient with 100% oxygen for 2 minutes.</i_keyword>
      <i_keyword>Control group: Firstly, inner surface of the mouth is thoroughly washed using a soft brush (for kids) on which 0.5 cm of fluoride-rich toothpaste is applied followed by a suction stage. Next, 15 mL of the chlorhexidine 0.2 solution is used to wash all the surfaces across the entire mouth, lounge, and teeth using a sterilized syringe. After 30 seconds, the patient’s mouth is subjected to suction at a pressure of -100 mmHg for a maximum of 10 seconds followed by hyper-oxygenating the patient with 100% oxygen for 2 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Oral health. Timepoint: Every other day. Method of measurement: Beck Oral Assessment Scale (BOAS), Mucosal Plaque Score (MPS).</prim_outcome>
      <prim_outcome>Incidence of ventilator-associated pneumonia. Timepoint: Before the intervention and after the intervention. Method of measurement: Clinical Pulmonary Infection Score (CPIS), Cultivation of pharynx.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-02</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی بقیه الله (عج)</contact_name>
        <contact_address>Mullasadra Street,Vanak Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
