<?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>IRCT20180107038251N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-20</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of nebulized eucalyptus on arterial blood gas and physiologic indexes</public_title>
      <acronym></acronym>
      <scientific_title>Effect of nebulized eucalyptus on arterial blood gas and physiologic indexes of ventilated patients:A Double-Blind Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40368</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple Randomization with tossing a coin method
we used from this method for creating random sequence, so that we considered one of study groups (intervention) as heads and other group (control) as tails and based on sample size we threw the coin and subjects were randomly assigned  to two groups, Blinding description: For elimination of the possibility of any probable bias due to the knowledge of  study Outcome evaluator about the type of treatment we performed a single blind study. Eucalyptus and placebo (normal saline) had the same appearance on the nebulizer device and This device was delivered vapors directly to patient as a fully enclosed enclosure and the evaluator did not notice the smell of eucalyptus in the room ,so Outcome evaluator did not have any knowledge about the type of treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Arterial blood gases analysis in mechanical ventilated patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Four ml of 5% eucalyptus made by medicinal herbs department in arak university will be diluted in 10 ml normal saline and will be nebulized in about 20 minutes through mechanical ventilator. This work will be performed every 8 hours until extubation. Intervention 2: Control group: Ten ml normal saline will be nebulized in about 20 minutes through mechanical ventilator. This work will be performed every 8 hours until extubation.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nazanin Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street  Arak  Markazi Province</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٣٨١٩٦٩٣٣٤٥</zip>
        <telephone>+98 34173507</telephone>
        <email>nazaninamini69@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Korosh Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street  Arak  Markazi Province</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>٣٨١٩٦٩٣٣٤٥</zip>
        <telephone>+98 86 3417 3507</telephone>
        <email>k.rezaei@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Oral intubation
18-65 years old
Lack of pulmonary infection
No sepsis
No pulmonary thromboembolism
No atelectasis
No gasterointestinal inflammatory disease
No severe hepatic disease
No allergy to herbal compounds</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z99.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependence on respirator</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Four ml of 5% eucalyptus made by medicinal herbs department in arak university will be diluted in 10 ml normal saline and will be nebulized in about 20 minutes through mechanical ventilator. This work will be performed every 8 hours until extubation.</i_keyword>
      <i_keyword>Control group: Ten ml normal saline will be nebulized in about 20 minutes through mechanical ventilator. This work will be performed every 8 hours until extubation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PH. Timepoint: Before intervention, three days after the start of intervention (third day),. Method of measurement: The GEM Premier 3000 device is used.</prim_outcome>
      <prim_outcome>Hco3. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: The GEM Premier 3000 device is used.</prim_outcome>
      <prim_outcome>Base excess. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: The GEM Premier 3000 device is used.</prim_outcome>
      <prim_outcome>Pao2. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: The GEM Premier 3000 device is used.</prim_outcome>
      <prim_outcome>Sao2. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: The GEM Premier 3000 device is used.</prim_outcome>
      <prim_outcome>Paco2. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: The GEM Premier 3000 device is used.</prim_outcome>
      <prim_outcome>Systolic blood pressure. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: automatic blood pressure from Cardio set x-110 IEI device was used to measure blood pressure.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: automatic blood pressure from Cardio set x-110 IEI device was used to measure blood pressure.</prim_outcome>
      <prim_outcome>Temperature. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: thermometer.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: respiratory rate per minute.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: pals oximeter.</prim_outcome>
      <prim_outcome>Level of consciousness. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: Glasgow Coma Scale.</prim_outcome>
      <prim_outcome>Peak inspiratory pressure. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: Ventilator respiratory parameter.</prim_outcome>
      <prim_outcome>Tidal volume. Timepoint: Before intervention, three days after the start of intervention (third day). Method of measurement: Ventilator respiratory parameter.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-14</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Sardasht,  Arak  Markazi Province Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
