<?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>IRCT2015061012257N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-15</date_registration>
      <primary_sponsor>Vice chancellor for research(Science and Technology) , Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Determine the effect of the artificial airway of open suctioning based on the standard criteria that need to have suction in the hemodynamic status and also pulmonary patients hospitalized in the intensive care units.</public_title>
      <acronym></acronym>
      <scientific_title>Determine the effect of the artificial airway of open suctioning based on the standard criteria that need to have suction in the hemodynamic status and also pulmonary patients hospitalized in the intensive care units.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12354</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patients with airway artificial lung.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group: After random sampling of the patients, The standard suction method with other standard criteria will be taught to working and volunteer nurses in both control and experimental groups. Then the control group nurses are asked to performed standard suction without consideration of standard criteria of suctioning. The participant nurses of this study have bachelor degree in nursing and their minimum working experience is about three years in ICU ward of Mousavi and Vali Asr hospitals that had passed scientific and standard principles of airway suction in the educational workshops. In the experimental group, the patients will be evaluated in terms of their need to have artificial airway suction based on the standard criteria and in the condition of necessity the suction will be performed in the standard method. Intervention 2: Control group: in the control group, suction will be done based on routine standard criteria.</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>Farshid Alazmani Noodeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery faculty, Parvin Etesami square, Zanjan. Iran.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515789589</zip>
        <telephone>+98 24337072057</telephone>
        <email>Farshid.Gorgani@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhad Ramazani Badr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery faculty, Parvin Etesami square, Zanjan. Iran.</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515789589</zip>
        <telephone>+98 24 3377 2513</telephone>
        <email>Ramezanibadr@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having a minimum age of 18 and maximum age of 70 years؛ An artificial airway Having vital signs within normal limits.&#13;
 Exclusion criteria: Not having cardiac and pulmonary monitoring؛ A serve heart or lung disease؛ Chronic obstructive disease high intracranial pressure؛ Pulmonary parameters and vital signs within normal limits؛ Dopamine medication؛ Dubatomin؛ Nitroglycerin and increasing the blood pressure_lowering drugs؛ Removal of the ventilator؛  and the patient death during the study ؛ Having significant problem after the first suction or having an urgent need to have second suction؛ And also the patients who do not have suction problems (Airway bleeding؛ Fractures؛ et) and the patients under CMV made will not be considered in this study.</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J95-J99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of upper respiratory tract</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group: After random sampling of the patients, The standard suction method with other standard criteria will be taught to working and volunteer nurses in both control and experimental groups. Then the control group nurses are asked to performed standard suction without consideration of standard criteria of suctioning. The participant nurses of this study have bachelor degree in nursing and their minimum working experience is about three years in ICU ward of Mousavi and Vali Asr hospitals that had passed scientific and standard principles of airway suction in the educational workshops. In the experimental group, the patients will be evaluated in terms of their need to have artificial airway suction based on the standard criteria and in the condition of necessity the suction will be performed in the standard method.</i_keyword>
      <i_keyword>Control group: in the control group, suction will be done based on routine standard criteria.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean Arterial pressure. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: Mm Hg, by monitoring patients.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: Mm Hg, by monitoring patients.</prim_outcome>
      <prim_outcome>Respiratory Rate. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: The minutes of number, by cardiac monitoring.</prim_outcome>
      <prim_outcome>Saturation of arterial hemoglobin. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: Percentage minutes, by cardiopulmonary monitoring.</prim_outcome>
      <prim_outcome>Resistance airway. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: Cm of H2O per minute, ventilator.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: The minutes of number, by cardiac monitoring.</prim_outcome>
      <prim_outcome>Tidal Volume. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: Cc per kg; ventilator.</prim_outcome>
      <prim_outcome>Compliance. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: Ml cm of H2O; ventilator.</prim_outcome>
      <prim_outcome>Mean airway pressure. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: ventilator.</prim_outcome>
      <prim_outcome>Minute volume. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: Cc per kg; ventilator.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intracranial pressure. Timepoint: Before the five minutes after opening the airway suctioning artificial. Method of measurement: Mm Hg, intracranial shunt.</sec_outcome>
      <sec_outcome>And the patient death during the study. Timepoint: Before two and five minutes after opening the airway suctioning artificial. Method of measurement: Questionnaire.</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>Vice chancellor for research(Science and Technology) , Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-22</approval_date>
        <contact_name>Vice chancellor for research(Science and Technology) , ethical deputy committee, Zanjan University o</contact_name>
        <contact_address>University of Medical Sciences, Third floor of research department (Science and Technology) Vice chancellor for research, Zanjan medical University deoartment, Zanjan. Iran. Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
