<?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>IRCT2014111318342N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-10</date_registration>
      <primary_sponsor>Vice chancellor for research, Qazvin University of Medical Sciences</primary_sponsor>
      <public_title>Assessment the effect of body position during sleep on the pressure of the respiratory tract in brain injury patients</public_title>
      <acronym></acronym>
      <scientific_title>Assessment the effect of changing body position on endotracheal tube cuff pressure in head trauma patients with mechanical ventilation who admitted in ICU ward</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-10-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16660</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Head trauma.</hc_freetext>
      <i_freetext>First the patients will be placed in a neutral position (°  angle to the head of the bed  and head towards the body) for initiating data collection. Tracheal tube cuff pressure in end-expiratory pause (for 4-5 seconds) of mechanical ventilation can be measured and recorded in cm water with a standard manometer, If the cuff pressure is in inappropriate level, endotracheal tube cuff pressure will adjust in the range of 27 cm H2o. Then the patient's position will change in each two hours sequence determined by researcher; left lateral position with a 30° angle to the head of the bed and head towards the body, right lateral position with a 30° angle to the head of the bed and head towards the body, semi-upright position at 45°  angle to the head of the bed  and head towards the body, left lateral position with 45°  angle to the head of the bed and head towards the body, right lateral position with a 45°   angle to the head of the bed and head towards the body. In each patient's change position, endotracheal tube cuff pressure will measure and record immediately before and after change position, after 15 minutes and finally after 2 hours. Patient's body core temperature, blood pressure, respiratory rate and heart rate will measure before and after change position, after 15 minutes and finally after 2 hours using infrared thermometer and monitoring devices. Patients during the measurements should be at level 5 according to the Richmond Agitation Sedation Scale and based on behavioral pain scale , they should be at 3-4 level, otherwise they will be excluded..</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>Azam Mohammadi Alamouti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419759811</zip>
        <telephone>002833338127</telephone>
        <email>azam.mohammadi60@yahoo.comamohammadi@qums.ac.ir</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Shahrokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3419799811</zip>
        <telephone>002833328127</telephone>
        <email>ashahrokhi@qums.ac.ir</email>
        <affiliation>Qazvin 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: The included group will be 18-65 years old of both genders; They should not have intubated  more than 72 hours; patients should be in a lull level of -5 according to Richmond scale; Patients should be in a level of 3-4 according to behavioral pain scale; Intra tube suction has not done through 30 min before measurement of cuff pressure; Intubation should be done using low pressure and high volume tracheal tubes made by the same factory. &#13;
Exclusion criteria: Pregnancy; presence of any injury or movement limitation due to any reason in neck vertebrae; short neck confirmed by physical examination done by physician; spinal injuries; tracheal anomalies (tracheomalacia) confirmed by physician;  Cushing's triad (heart rate less than 60 beats per minute; breathing rate less than 8 per minute; systolic blood pressure greater than 140 mmhg); multiple trauma patients; difficult intubation according to physician report; arm perimeter greater than 32 cm (BMI&gt;30)؛ Temperature greater than 38.3 and less than 35 ° C؛  respiratory rate greater than 35 times per minute؛ heart rate greater than 100 beats per minute؛  systolic blood pressure less than 90 mm Hg؛  mean arterial pressure below 60 mmHg</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S09.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple injuries of head</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First the patients will be placed in a neutral position (°  angle to the head of the bed  and head towards the body) for initiating data collection. Tracheal tube cuff pressure in end-expiratory pause (for 4-5 seconds) of mechanical ventilation can be measured and recorded in cm water with a standard manometer, If the cuff pressure is in inappropriate level, endotracheal tube cuff pressure will adjust in the range of 27 cm H2o. Then the patient's position will change in each two hours sequence determined by researcher; left lateral position with a 30° angle to the head of the bed and head towards the body, right lateral position with a 30° angle to the head of the bed and head towards the body, semi-upright position at 45°  angle to the head of the bed  and head towards the body, left lateral position with 45°  angle to the head of the bed and head towards the body, right lateral position with a 45°   angle to the head of the bed and head towards the body. In each patient's change position, endotracheal tube cuff pressure will measure and record immediately before and after change position, after 15 minutes and finally after 2 hours. Patient's body core temperature, blood pressure, respiratory rate and heart rate will measure before and after change position, after 15 minutes and finally after 2 hours using infrared thermometer and monitoring devices. Patients during the measurements should be at level 5 according to the Richmond Agitation Sedation Scale and based on behavioral pain scale , they should be at 3-4 level, otherwise they will be excluded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endotracheal tube cuff pressure. Timepoint: Immediately before and after and 15 minutes after intervention. Method of measurement: Manometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Temperature. Timepoint: Immediately before and after and 15 minutes after intervention. Method of measurement: Thermometer.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Immediately before and after and 15 minutes after intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Immediately before and after and 15 minutes after intervention. Method of measurement: Enumeration.</sec_outcome>
      <sec_outcome>Respiritory rate. Timepoint: Immediately before and after and 15 minutes after intervention. Method of measurement: Enumeration.</sec_outcome>
      <sec_outcome>Mean airway pressure. Timepoint: Immediately before and after and 15 minutes after intervention. Method of measurement: Mechanical ventilation device.</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, Qazvin University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-10-27</approval_date>
        <contact_name>Ethics committee of Qazvin university of medical sciences</contact_name>
        <contact_address>Qazvin university of medical sciences, Shahid bahonar boulevard, Qazvin, Iran Qazvin  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
