<?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>IRCT20200815048408N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-30</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of peep and fio2 modulation on outcome"</public_title>
      <acronym></acronym>
      <scientific_title>Investigating The Effect of Adjustment of Peep and Fio2 Based on Arterial Blood Oxygen Pressure on the Care and Treatment Outcomes of Icu Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The study is a pilot and the sample size can be changed, Randomization description: Block random allocation method (5 blocks, each block including 6 patients are selected from both intervention and control groups. The number of possible cases from the arrangement of control and intervention patients is determined by MCMCMC that are not duplicates and 6 cases are randomly selected and to each  Block is assigned a state, the first block of patients with hyperoxemia, the second block of patients with hypoxemia and also up to block 4 and the last block four to two of each group is placed in the control and intervention group of 8 patients with hyperoxemia and 7 patients with hypoxemia.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Changing the two parameters of peep and fio2 from the ventilator device according to the arterial blood oxygen pressure in the form of hypoxemia and hyperoxemia on the therapeutic outcomes and care of patients admitted to the intensive care unit..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 15 people in the intervention group, 7 of whom have hypoxemia pao2 &lt;60mmhg and 8 people have hyperoxemia Pao2&gt; 120mmhg, which are randomly divided into 6 blocks.In these two groups in the intervention group, due to arterial blood oxygen pressure, the two parameters of peep and fio2 decrease or increase during 7 days. And according to the sofa criterion, the patient's condition is evaluated. Intervention 2: Control group: 15 patients, including 7 patients with hypoxemia and 8 cases of hyperoxemia, and the parameters of peep and fio2 are routinely adjusted, and the sofa criterion is recorded within 7 days and the patient's condition is checked.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Reports on blood test, sex, age, date of hospitalization, length of hospital stay, underlying disease, ventilator parameters

When:
"Access period starts 6 months after the results are published"

To whom:
Employees in universities and researchers

Conditions:
Help improve the condition of patients admitted to the intensive care unit, help reduce costs, use as a resource for other research.

Where to obtain:
Email address

How to obtain:
Have basic scientific information about ventilators

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe Moghaddas Ghahfarokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 368, Corner of Bustan 2., Bustan Ave</address>
        <city>Khoramshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6417717743</zip>
        <telephone>+98 61 5352 3262</telephone>
        <email>Mgh.gh1990@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Moghaddas Ghahfarokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 368, Corner of Bustan 2., Bustan Street</address>
        <city>Khoramshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۴۱۷۷۱۷۷۴۳</zip>
        <telephone>+98 61 5352 3262</telephone>
        <email>mgh.gh1990@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age group 60-18 years
Intubation and connection to the ventilator
GCS score of at least 6
No lung disease, lung cancer and COPD</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Discharge or death of the patient before the intended time for intervention
Use of muscle relaxants
Post CPR patients
Unstable hemodynamics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified complications of surgical and medical care, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 15 people in the intervention group, 7 of whom have hypoxemia pao2 &lt;60mmhg and 8 people have hyperoxemia Pao2&gt; 120mmhg, which are randomly divided into 6 blocks.In these two groups in the intervention group, due to arterial blood oxygen pressure, the two parameters of peep and fio2 decrease or increase during 7 days. And according to the sofa criterion, the patient's condition is evaluated.</i_keyword>
      <i_keyword>Control group: 15 patients, including 7 patients with hypoxemia and 8 cases of hyperoxemia, and the parameters of peep and fio2 are routinely adjusted, and the sofa criterion is recorded within 7 days and the patient's condition is checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Arterial blood oxygen pressure in the form of hypoxemia (Pao2&lt;60mmhg)and hyperoxemia(Pao2&gt;120mmhg). Timepoint: Before the intervention and during 7 days of intervention. Method of measurement: arterial blood gases.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-29</approval_date>
        <contact_name>Ethics committee of Ahwaz University of Medical Sciences</contact_name>
        <contact_address>No. 368, Corner of Bustan 2., Bustan Street Khoramshahr Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
