<?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>IRCT20171202037703N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-28</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two types of airway humidifier in ventilated patients on pulmonary parameters and infection rates</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the Active And Passive Humidifiers On The Parameters Of Pulmonary And Ventilator Associated Pneumonia In Patients Admitted To Intensive Care Units.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27915</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Initial sampling was done in random sampling by pilot method. Because sampling method and all intervention methods were similar to pilot samples in pilot sampling, pilot samples were also considered as the main samples. In order to control the interventional variables and the equivalence of the samples in the two groups, after the selection of each sample, the sample is randomly selected and used by the blocking method in the test or control group to obtain the appropriate sample size. In the blocking technique, blocks with a pair size (usually four or six) are created, in which, randomly, half of the individuals in each block are placed in one group and the other in the other group; then, as much The block is selected to reach the required sample size. For example, if we want to put 80 people in two groups of 40 in A and B, then we first consider all four modes in which half of the individuals assigned to group A and the other half to group B. We will determine.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Moisturizers act in a ventilator like an artificial nose. Oxygen, along with the volume produced, which is a dry gas, is heated and humidified by Humidifier, and is passed to the patient's lungs. Without proper moisturizing, it can damage the lungs and increase lung parameters and even infection (Ventilator Associated Pneumonia) causing Prolonging the process of separating patients from the device..</hc_freetext>
      <i_freetext>Intervention group: In this study, in the intervention group, active Hymo modifiers are used and in the control group, the inactive mediums are used. In the intervention group (active method), Rafail brand ventilator devices that are made in Switzerland are used. The humidity system (active method) consists of a Humidifier and Chambre. This system is designed to give the patient the best amount of moisture to create a minimum of condensation. The cold and dry medical air (at a temperature of 37 ° C and humidity of 0.5 mg / l) outlet from the ventilator, pass through the Humidifier and pass through the chambers, warm and humid. Inactive Humidifier Control (HME) is used, which does not require external water, and is located between the Y (ventilator tube path) and the tracheal tube, which acts on the basis of the heat and moisture of the exhaled air and returns it to the lungs. Slowly.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parvin Shiri Gheydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Mosalla Ave, Paien koh, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4519936938</zip>
        <telephone>+98 24 3347 1049</telephone>
        <email>shirig@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Shiri Gheydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Mosalla Ave, Paien koh, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4519936938</zip>
        <telephone>+98 24 3347 1049</telephone>
        <email>shirig@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing mechanical ventilation following 12 hours of intubation and mechanical ventilation and undergo mechanical ventilation during the study; Having vital signs in the normal range, not using dopamine, double-breasted or nitroglycerin, and hypotensive drugs؛ Patients should not have artificial teeth; Patients aged 18-60 years old; Modem of the ventilator is SIMV and the size of the tracheal tube is 7 to 8; patients have history of pneumonia, aspiration, chemotherapy, pulmonary injury in the lower airways, exacerbated myasthenia grave and recent MI; A pregnant woman is not pregnant or burn7</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who take pentoprazole instead of ranitidine; Age over 60 years; Chronic pulmonary disease; Having a chest tube and a pulmonary canine; Patients diagnosed with burns;</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, in the intervention group, active Hymo modifiers are used and in the control group, the inactive mediums are used. In the intervention group (active method), Rafail brand ventilator devices that are made in Switzerland are used. The humidity system (active method) consists of a Humidifier and Chambre. This system is designed to give the patient the best amount of moisture to create a minimum of condensation. The cold and dry medical air (at a temperature of 37 ° C and humidity of 0.5 mg / l) outlet from the ventilator, pass through the Humidifier and pass through the chambers, warm and humid. Inactive Humidifier Control (HME) is used, which does not require external water, and is located between the Y (ventilator tube path) and the tracheal tube, which acts on the basis of the heat and moisture of the exhaled air and returns it to the lungs. Slowly</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pneumonia is caused by a ventilator. Clinical pulmonary infection score (CPIS) was used to diagnose pneumonia. In this scale, body temperature, infiltration rate in the lung graph, fever, discharge volume and Pao2 to Fio2 ratio were evaluated. This tool is a standard method for diagnosis of pneumonia. Timepoint: Within seven days. Method of measurement: Clinical pulmonary infection score (CPIS) was used to diagnose pneumonia. In this scale, body temperature, infiltration rate in the lung graph, fever, discharge volume and Pao2 to Fio2 ratio were evaluated. This tool is a standard method for diagnosis of pneumonia.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-08</approval_date>
        <contact_name>Ethics committee of zanjan  university of medical sciences</contact_name>
        <contact_address>Azadi Square. Zanjan University of Medical Sciences zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
