<?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>IRCT2015092624213N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-22</date_registration>
      <primary_sponsor>Vice chancellor for research, Babol University of Medical Sciences</primary_sponsor>
      <public_title>Endotracheal suctioning and hemodynamic status</public_title>
      <acronym>SICU: Surgical Intensive Care Unit</acronym>
      <scientific_title>Comparison the effect of open and close endotracheal suctioning on hemodynamic status of patient with head trauma hospitalized in intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20499</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>head trauma.</hc_freetext>
      <i_freetext>Intervention 1: After getting oxygenated with 100% O2 for one minute, the patients are suctioned with closed suction method for 15 seconds. The catheter will be inserted into the endotracheal tube and then will be withdrawn back for 0.5 cm. A negative pressure of maximum 20 KPa will be set, and catheter will be withdrawn. They will also receive 100% oxygen for one minute after suctioning. Intervention 2: After getting oxygenated with 100% O2 for one minute, the patients are suctioned with closed suction method for 15 seconds. The catheter will be inserted into the endotracheal tube and then will be withdrawn 0.5 cm. A negative pressure of maximum 20 KPa will be set, and catheter will be withdrawn. They will also receive 100% oxygen for one minute after suctioning.</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>Asieh Shabani Faramarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 39, Zoolfaghar Alley, Keshvari Square, Babol, Mazandaran, Iran</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4716758393</zip>
        <telephone>+98 11 3225 5939</telephone>
        <email>asiehshabanifaramarzi@gmail.com</email>
        <affiliation>Ardabil University of medical science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behrooz Dadkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery faculty, Saedi street, Ardabil, Iran</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 45 3351 2877</telephone>
        <email>b.dadkhah@arums.ac.ir</email>
        <affiliation>Ardabil University of medical science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria;&#13;
1. Patients without lung problems&#13;
2. Age more than 12 years old&#13;
3. Head trauma&#13;
4. Level of consciousness between 4-8&#13;
5. Patients with Endotracheal tube&#13;
6. Hemodynamic stability&#13;
7. lack of dysrhythmia&#13;
Exclusion criteria:&#13;
1.  Patients require frequent suctioning&#13;
2. Any serious adverse effects during study(increasing of intracranial pressure, Severe impairment in hemodynamic status)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S00-S09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of skull with associated intracranial injury, Fracture of vault of skull, Fracture of base of skull, Multiple superficial injuries of head</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After getting oxygenated with 100% O2 for one minute, the patients are suctioned with closed suction method for 15 seconds. The catheter will be inserted into the endotracheal tube and then will be withdrawn back for 0.5 cm. A negative pressure of maximum 20 KPa will be set, and catheter will be withdrawn. They will also receive 100% oxygen for one minute after suctioning.</i_keyword>
      <i_keyword>After getting oxygenated with 100% O2 for one minute, the patients are suctioned with closed suction method for 15 seconds. The catheter will be inserted into the endotracheal tube and then will be withdrawn 0.5 cm. A negative pressure of maximum 20 KPa will be set, and catheter will be withdrawn. They will also receive 100% oxygen for one minute after suctioning.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before and immediately after suctioning and then every five  minutes  up to fifteen minutes. Method of measurement: Observation and records.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before, during and  immediately after suctioning and then every five minutes up to fifteen minutes. Method of measurement: Observation and records.</prim_outcome>
      <prim_outcome>Mean Arterial Pressure. Timepoint: Before, during  and immediately after suctioning and then every five  minutes  up to fifteen minutes. Method of measurement: Observation and records.</prim_outcome>
      <prim_outcome>Arterial Blood Oxygen Saturation. Timepoint: Before, during  and immediately after suctioning and then every five  minutes  up to fifteen minutes. Method of measurement: Observation and records.</prim_outcome>
      <prim_outcome>Cardiac dysrhythmia. Timepoint: During  and Immediately after suctioning and then every five minutes up to fifteen minutes. Method of measurement: Observation and records.</prim_outcome>
      <prim_outcome>Central Vein Pressure. Timepoint: Before and immediately after suctioning and then every five  minutes  up to fifteen minutes. Method of measurement: Observation and records.</prim_outcome>
      <prim_outcome>Positive End Expiratory Pressure. Timepoint: Before, during and Immediately after intervention, Five, Ten, Fifteen minutes after open and close suction. Method of measurement: Observation and records.</prim_outcome>
      <prim_outcome>Added at 2016-02-25: number of suctioning. Timepoint: Added at 2016-02-25: Before, during and immediately after suctioning and then every five minutes up to fifteen minutes. Method of measurement: Added at 2016-02-25: observation and records.</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>Vice chancellor for research, Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-08-08</approval_date>
        <contact_name>Ethic committee of Ardabil University of Medical Science</contact_name>
        <contact_address>Ethic committee  unit, Vice chancellor for research, Ardabil University of Medical Science, Kosar town,  Ardabil, Iran Ardabil  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
