<?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>IRCT20181105041560N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-19</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The Relationship Between changing patient position in Bed with Intra Abdominal Pressure and its Consequences among mechanically ventilated patients</public_title>
      <acronym></acronym>
      <scientific_title>The Relationship Between changing patient position in Bed with Intra Abdominal Pressure and its Consequences among mechanically ventilated patients admitted to intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35103</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Intra Abdominal Presure.</hc_freetext>
      <i_freetext>Control group: This study is an interventional study of the type before and after.In such a way that each person in different states of the body will be used as a witness for himself..</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yusef Haghighi moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Nazloo</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>hagigym@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yusef Haghighi moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Nazloo</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>hagigym@yahoo.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age &gt; 18 years old
Mechanically ventilated patient
Have indwelling urine catheter in place
Scor of Critical care Pain Observation Tool ≤2
Length of ICU stays ≥ 48 hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unable to change position
Norogenic bladder
Bladder rupture
Hematuria
Heart failure and Pulmonary edema
Pregnancy
Excessive obesity
Acute abdominal patients
Probability of survival less than 24 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: This study is an interventional study of the type before and after.In such a way that each person in different states of the body will be used as a witness for himself.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intra Abdominal Pressure:The intra-abdominal pressure is a sustained pressure that lies inside the abdominal cavity. Timepoint: we will Measure inetra abdominal pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours. Method of measurement: Measuring  Intera-vesical pressure by water manometer of central vein pressure measuring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean Arterial Pressure: It is the average amount of the systemic pressure with normal range of 70 to 105 mm Hg. Timepoint: we will Measure the Mean Arterial Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours. Method of measurement: It will be measured by a monitor device attached to the patient.</sec_outcome>
      <sec_outcome>Abdominal Perfusion Pressure:If the intra-abdominal pressure is lowered from the median arterial pressure, abdominal perfusion pressure will be obtained. In adults, it should be above 50 mm Hg to provide adequate ventricular perfusion. Timepoint: we will measure Abdominal Perfusion Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours. Method of measurement: we will Calculate the Abdominal Perfusion Pressure with subtraction the mean arterial pressure measured by the monitor attached to the patient and intera abdominal pressure measured by water manometer.</sec_outcome>
      <sec_outcome>Mean Airway Pressure:It is the pressure measured at the airway opening, averaged over the entire ventilatory cycle. Timepoint: we will measure the Mean Airway Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours. Method of measurement: It will be measured by the ventilator device attached to the patient.</sec_outcome>
      <sec_outcome>Peak Inspiratory Pressure:It is the highest level of pressure applied to the lungs during inhalation. Timepoint: we will measure the Peak Inspiratory Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours. Method of measurement: It will be measured by the ventilator device attached to the patient.</sec_outcome>
      <sec_outcome>Plateau Pressure:It is the pressure of the air ways at the end of inspration. Timepoint: we will measure the Plateau Pressure in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours. Method of measurement: It will be measured by the ventilator device attached to the patient.</sec_outcome>
      <sec_outcome>Auto PEEP: The Positive End Expratory Pressure in the air ways that is becouse of inadequate expratory tim. Timepoint: we will measure the Auto PEEP in each of the different situations(15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) first time before changing the position of the patient in 0 degree head of bed, second time, 20 minute after changing position,and third tim, 20 minut after returning to 0 degree.interval among the interventions( put the patients in different positions of 15 degree, 30 degree, 45 degree, right lateral position with 30 degree, left lateral position with 30 degree) will be 2 hours. Method of measurement: It will be measured by the ventilator device attached to the patient.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-29</approval_date>
        <contact_name>Ethics committee of Urmia  University of Medical Sciences</contact_name>
        <contact_address>Next to the Emergency department., Jahad Ave., Resalat Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
