<?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>IRCT20100527004041N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-26</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of post intubation endotracheal suction on respiratory parameters in children with airway secretion</public_title>
      <acronym></acronym>
      <scientific_title>Effect of post intubation endotracheal suction before surgery on respiratory parameters in children with airway secretion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4227</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: the surgery candidate children in "The children medical research and training hospital, Tabriz" will randomly  be chosen using random number table and random permuted blocks divided in two 50 members groups, Blinding description: Each patient will be auscultated by a pediatric anesthesia specialist. If diagnosed with abnormal auscultation , patient enters the study , regardless of the intensity of abnormality and will be compared with him/her self before and after suction.The data will be gathered by a pediatric anesthesia specialist with help of experienced nurses. Patients, the person who responsible of recording vital signs  and analyzer of data are not informed about whether the airways  have been suctioned or not.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with abnormal pulmonary auscultation.</hc_freetext>
      <i_freetext>Intervention 1: Cases:Patients who had tracheal suction before surgery patients without  tracheal suction before surgery in first group post intubation suction will be performed  open and deeply,2 or 3 times till all secretions are eliminated and abnormal sounds are gone.Patients will be ventilated after every suction. Intervention 2: Control group:in control group anesthesia will continue without pulmonary secretions suction.</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:
we are going to publish all in a paper

When:
in the end of study

To whom:
every one who read the paper

Conditions:
If the data is needed to be used for further analysis, only the study designer has access to the codes and patients information. If the data is going to be used in another study, a proposal (in which the goals of study are established) should be registered and ethics code must be received.

Where to obtain:
from the paper

How to obtain:
no need for special process

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin Seyed Hejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz children hospital , Sheshgelan St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 3526 2257</telephone>
        <email>seidhejazie@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Seyed Hejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz children hospital , Sheshgelan St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 3526 2257</telephone>
        <email>seidhejazie@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are between 1 month to 6 years old
Patients need to intubate for surgery
Patients have coarse crackle in auscultation caused by secretion.
Urgent Patients with common cold</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients with persistent pulmonary hypertension(PPH)
fever
children with airway malformation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute bronchitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Cases:Patients who had tracheal suction before surgery patients without  tracheal suction before surgery in first group post intubation suction will be performed  open and deeply,2 or 3 times till all secretions are eliminated and abnormal sounds are gone.Patients will be ventilated after every suction.</i_keyword>
      <i_keyword>Control group:in control group anesthesia will continue without pulmonary secretions suction</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Short time side effects. Timepoint: discharge from recovery. Method of measurement: observational.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before surgery-during recovery. Method of measurement: Vital signs monitoring device.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before surgery, 5 minutes after suction ,every 15 minutes after intubation and during recovery. Method of measurement: Vital signs monitoring device.</prim_outcome>
      <prim_outcome>SPO2( Blood Oxygen Saturation). Timepoint: Before surgery, 5 minutes after suction ,every 15 minutes after intubation and during recovery. Method of measurement: pulse oximeter.</prim_outcome>
      <prim_outcome>Expiratory CO2. Timepoint: every 15 minutes after intubation. Method of measurement: Vital signs monitoring device.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: before surgery, 5 minutes after suction ,every 15 minutes after intubation and during recovery. Method of measurement: Vital signs monitoring device.</prim_outcome>
      <prim_outcome>Pressure of the airway. Timepoint: every 15 minutes  after intubation. Method of measurement: Anesthesia manometer.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-28</approval_date>
        <contact_name>university /regional research ethics committee Tabriz university medical of sciences</contact_name>
        <contact_address>Tabriz Unversity of Medical Sciences, Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
