<?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>IRCT2016052311399N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-14</date_registration>
      <primary_sponsor>Vice chancellor for research, Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The comparison of close and open tracheal tube suction on severity of pain and physiological indicators in patients under mechanical ventilation with traumatic brain injuries</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of close and open tracheal tube suction on severity of pain and physiological indicators in patients under mechanical ventilation with traumatic brain injuries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>116</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11674</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Other design features: Patients will be divided into two groups by using sealed envelopes method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Pain. Condition 2: physiological indicators. Condition 3: Traumatic brain injuries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (1): Patient will receive 100% oxygen for two minutes by ventilator. Then the patient is disconnected from ventilator and suction will be done by sterile method from ventilator and using a catheter number 14 and the pressure less than 120 mm Hg for 14 seconds and consequently the patient’s endotracheal tube is connected to ventilator again and he will be undergone 100% oxygen therapy by ventilator for two minutes. Intervention 2: Intervention group (2): Patient will not be disconnected from the ventilator. In these patients the suction catheter goes through the endotracheal tube through Y-piece connector between endotracheal tube and ventilator tube and suction will be done. In these patients suction will be done by catheter suction for 14 seconds with -120 mm Hg.The patient will be undergone 100% oxygen therapy by ventilator before and after suction.</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>Hossein Davari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar Hospital, basij Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3343 7825</telephone>
        <email>hosseindavari30@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbasali Ebrahimian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3365 4191</telephone>
        <email>aa.ebrahimian@semums.ac.ir, ebrahimian.aa@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The Patient is placed under mechanical ventilation simply due to traumatic brain injuries or to subsequent secondary complications; The patient is in a coma and his GCS is less than 8; Endotracheal tube is used for patients in order to get airway; Endotracheal tube is merely through the mouth; They don’t take pain medications; Their livers and kidneys do not have trauma in the latest incident; They don’t take neuromuscular blockers; They need endotracheal tube secretion suctioning and patients don’t have severe face injuries. Exclusion criteria: The patient is brain-dead; They need to regain their suction before two hours; The existence of dangerous cardiac arrhythmias in monitoring patients; Any pain before suctioning; The use of painkillers or drugs on the stimulation of the patient’s upper airway secretions drainage and history of patients’ CPR after hospitalization.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.9</hc_code>
      <hc_code>R62.8</hc_code>
      <hc_code>Intracrani</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
      <hc_keyword>Other lack of expected normal physiological development</hc_keyword>
      <hc_keyword>S06.9</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (1): Patient will receive 100% oxygen for two minutes by ventilator. Then the patient is disconnected from ventilator and suction will be done by sterile method from ventilator and using a catheter number 14 and the pressure less than 120 mm Hg for 14 seconds and consequently the patient’s endotracheal tube is connected to ventilator again and he will be undergone 100% oxygen therapy by ventilator for two minutes.</i_keyword>
      <i_keyword>Intervention group (2): Patient will not be disconnected from the ventilator. In these patients the suction catheter goes through the endotracheal tube through Y-piece connector between endotracheal tube and ventilator tube and suction will be done. In these patients suction will be done by catheter suction for 14 seconds with -120 mm Hg.The patient will be undergone 100% oxygen therapy by ventilator before and after suction.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before suctioning, during suctioning, 5 minutes after suctioning. Method of measurement: Critical-care pain objective tool.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physiological indicators. Timepoint: Before suctioning, during suctioning, 5 minutes after suctioning. Method of measurement: Monitoring devices, pulse oximetry, recorded ETCo2.</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, Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-25</approval_date>
        <contact_name>Ethic committee of Semnan University Of Medical sience</contact_name>
        <contact_address>Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
