<?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>IRCT2016080729234N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-06</date_registration>
      <primary_sponsor>Vice Chancellor for research of Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Effect of mechanical ventilation on oxynation and  hemodynamic in head trauma.</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Comparison of synchronized intermittent mandatory ventilation and airway pressure release ventilation in oxynation  and hemodynamic parameters in patients with head trauma.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23553</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Head trauma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention of this research is a ventilation mode is called Airway Pressure Release Ventilation that will be applied through ventilator and tracheal tube for half an hour. This mode is an inverse ratio mode in which patient airway pressure is fluctuated between high pressure and low pressure. In this intervention, the duration of high pressure is 4.5 sec and duration of low pressure is 0.5 sec. The high-level pressure will be determined based on the patient's required tidal volume. The patients in group 1 will receive SIMV for two hours then ABG will be taken   half an hour and two hours after changes. Then ventilator mode will be switched to APRV for two hours and ABG will be taken half an hour and two hours later. In all stages the values for ABG and vital signs will be recorded. Intervention 2: The patients in group 2 will receive APRV for two hours and after that ABG will be taken half an hour and two hours after changes. Then ventilator mode will be switched to SIMV for two hours and ABG will be taken half an hour and two hours later. In all stages the values for ABG and vital signs will be recorded.</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>Hassan Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, University campus building, Tohidshahr boulevard, Sabzevar.</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 51 4401 1300</telephone>
        <email>khalili894@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Hasan Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital, Ferdowsi threeway, Asiaie highway, Mashhad, Khorassan Razavi.l</address>
        <city>Masshad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9173500645</zip>
        <telephone>+98 51 3542 3970</telephone>
        <email>sadwho@yahoo.com</email>
        <affiliation>Taleghani Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 15 and 60 years; patients suffering from traumatic brain injuries who are intubated and are under mechanical ventilation with SIMV mode; stable hemodynamic (MAP more than 70 mm Hg for at least 30 minutes before the start of the study); Glasgow Coma Scale &lt;9 ; no history of chronic obstructive pulmonary disease (COPD); Exclusion criteria: unstable hemodynamic (MAP &lt;70); need to CPR.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>s06.2, s06</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other intracranial injuries, Intracranial injury with prolonged coma,Traumatic subarachnoid haemorrhage,Traumatic subdural haemorrhage,Diffuse brain injury,Focal brain injury,Epidural haemorrhage,</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention of this research is a ventilation mode is called Airway Pressure Release Ventilation that will be applied through ventilator and tracheal tube for half an hour. This mode is an inverse ratio mode in which patient airway pressure is fluctuated between high pressure and low pressure. In this intervention, the duration of high pressure is 4.5 sec and duration of low pressure is 0.5 sec. The high-level pressure will be determined based on the patient's required tidal volume. The patients in group 1 will receive SIMV for two hours then ABG will be taken   half an hour and two hours after changes. Then ventilator mode will be switched to APRV for two hours and ABG will be taken half an hour and two hours later. In all stages the values for ABG and vital signs will be recorded.</i_keyword>
      <i_keyword>The patients in group 2 will receive APRV for two hours and after that ABG will be taken half an hour and two hours after changes. Then ventilator mode will be switched to SIMV for two hours and ABG will be taken half an hour and two hours later. In all stages the values for ABG and vital signs will be recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pressure of arterial oxygen. Timepoint: Before intervention, half an hour and 2 hours after intervention. Method of measurement: Atrial blood gas (ABG).</prim_outcome>
      <prim_outcome>Pressure of arterial CO2. Timepoint: Before intervention, half an hour and 2 hours after intervention. Method of measurement: Atrial blood gas (ABG).</prim_outcome>
      <prim_outcome>Aterial oxygen saturation. Timepoint: Before intervention, half an hour and 2 hours after intervention. Method of measurement: Monitore.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean artery pressure. Timepoint: Before intervention, half an hour and 2 hours after intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Before intervention, half an hour and 2 hours after intervention. Method of measurement: Number in minute.</sec_outcome>
      <sec_outcome>Systolic pressure. Timepoint: Before intervention, half an hour and 2 hours after intervention. Method of measurement: Sphygmomanometer.</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 of Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-01</approval_date>
        <contact_name>Ethics committee of Sabzevar University of Medical Sciences.</contact_name>
        <contact_address>Central beulding of Sabzevar University of Medical Sciences, Assadabadi street, Sabzevar. Sabzevar  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
