<?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>IRCT20190120042436N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-06</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Effect of endotracheal suctioning on hemodynamic and respiratory parameters of patients undergoing mechanical ventilation</public_title>
      <acronym></acronym>
      <scientific_title>The comparison effect of combinational changes of catheter size and its related suction negative pressure on hemodynamic and respiratory parameters of patients undergoing mechanical ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: 35 patients with single-group mechanical ventilation each will be suctioned in 4 times with different catheter sizes and negative pressure.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coma, unspecified.</hc_freetext>
      <i_freetext>Intervention group: Intervention on 35 patients by single-group method Which will have a tracheal tube under mechanical ventilation Each patient is subjected to suction for 4 times, initially with a catheter of 10 and a negative pressure of 100 For the second time, a catheter of 10 and a negative pressure of 150 For the third time, a catheter of 12 and a negative pressure of 100 and  for the fourth time the catheter size 12 and the negative pressure 150 are used and the interval between two suction tracheal suction doses for each patient is at least 2 hours..</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>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohsen Salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Zaynab  nursing school . Dr.  shajid jalil Street, Yasuj , Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 33235140</telephone>
        <email>salarimo@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Salari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Zaynab  Nursing School. Dr. shajid jalil Street, Yasuj , Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3323 5140</telephone>
        <email>salarimo@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum age 18 and maximum 65 years
Having an endotracheal tube and connecting to fixed volume ventilator (SIMV-A / C)
The patient should be admitted at least 24 hours before the intervention in the intensive care unit and under mechanical ventilation and has an endotracheal tube with diameter of 7.5.
Stable hemodynamic status( Medium arterial pressure between 60-110 mm-Hg -Hypertension is more than 90 and less than 140- And diastolic pressure of less than 100 mm Hg-Heart rate less than 100 and more than 60 beats per minute -And oxygen saturation of arterial blood more than 90%)
Have a score of -2 to -5 based on the Richmond Agitation Sedation Scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having respiratory illnesses like asthma, emphysema,COPD, ARDS diagnosed by expert physician
The use of positive inotropic drugs, such as dopamine and dobutamine
Severe cardiovascular and pulmonary failure
High intracranial pressure
Having a score (-1 to 4+) based on Richmond's Scale
Having blood coagulation disorder and thrombocytopenia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R40.20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified coma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention on 35 patients by single-group method Which will have a tracheal tube under mechanical ventilation Each patient is subjected to suction for 4 times, initially with a catheter of 10 and a negative pressure of 100 For the second time, a catheter of 10 and a negative pressure of 150 For the third time, a catheter of 12 and a negative pressure of 100 and  for the fourth time the catheter size 12 and the negative pressure 150 are used and the interval between two suction tracheal suction doses for each patient is at least 2 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemodynamic parameters. Timepoint: Immediately before - immediately - 10 and 20 minutes after the trachea suction. Method of measurement: Central Monitor device.</prim_outcome>
      <prim_outcome>Respiratory parameters. Timepoint: Immediately before,  immediately, 10 and 20 minutes after the trachea suction. Method of measurement: Ventilator machine and computational formula.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Immediately before , immediately , 10 and 20 minutes after the trachea suction. Method of measurement: central Monitor device.</sec_outcome>
      <sec_outcome>فشار خون سیستول. Timepoint: Immediately before - immediately - 10 and 20 minutes after the trachea suction. Method of measurement: Central Monitor device.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Immediately before - immediately - 10 and 20 minutes after the trachea suction. Method of measurement: Central Monitor device.</sec_outcome>
      <sec_outcome>Median arterial pressure. Timepoint: Immediately before - immediately - 10 and 20 minutes after the trachea suction. Method of measurement: Central Monitor device.</sec_outcome>
      <sec_outcome>Arterial oxygen saturation. Timepoint: Immediately before - immediately - 10 and 20 minutes after the trachea suction. Method of measurement: Central Monitor device.</sec_outcome>
      <sec_outcome>Airway resistance. Timepoint: Immediately before ,immediately ,10 and 20 minutes after the trachea suction. Method of measurement: Computational formula.</sec_outcome>
      <sec_outcome>Dynamic compilation. Timepoint: Immediately before ,immediately  ,10 and 20 minutes after the trachea suction. Method of measurement: Computational formula.</sec_outcome>
      <sec_outcome>Maximum airway pressure. Timepoint: Immediately before ,immediately ,10 and 20 minutes after the trachea suction. Method of measurement: Ventilator Bennet 840.</sec_outcome>
      <sec_outcome>Plato Press. Timepoint: Immediately before , immediately , 10 and 20 minutes after the trachea suction. Method of measurement: Ventilator Bennet 840.</sec_outcome>
      <sec_outcome>Expiratory  tidal volume. Timepoint: Immediately before ,immediately , 10 and 20 minutes after the trachea suction. Method of measurement: Ventilator Bennet 840.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-16</approval_date>
        <contact_name>Ethics committee of yasuj University of Medical Sciences</contact_name>
        <contact_address>Assistance of Research and Technology of the University , Yasouj University of Medical Sciences , Shahid Motahari Blvd., Yasuj , Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
