<?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>IRCT20100527004041N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-22</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of laryngotracheal anesthesia for pediatric  bronchoscopy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of laryngotracheal anesthesia with McKenzie method for the ease of pediatric rigid bronchoscopy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41600</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients wishing to participate in the study who meet the inclusion criteria will be selected through convenient sampling and then randomly assigned to two control and intervention groups using Randlist software and blocks of size two, Blinding description: In this research, the thesis owner student provides the drugs to the anesthesiologist and is the only person who is not blind to the study.The anesthesiologist, who is in charge of the patient's anesthesia management, injects the drug through coded syringes that have already been prepared by the thesis owner.So that anesthesiologist is unaware of the injected drug to patient during injection.The anesthesia nurse, who is responsible for collecting information and variables from the patient and is unaware of the type of prescribed drug, fills in the checklist during surgery and recovery.The patient is also unaware of the type of Injecting drug.</study_design>
      <phase>3</phase>
      <hc_freetext>Pediatric bronchoscopy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In this group after induction and laryngoscopy, the blend of lidocaine 2%(Caspian Taamin pharmaceutical company)0.3milliliter per kilogram with oxygen in the laryngotracheal area will be flashed by the McKenzie method(A kind of anesthesia method). Intervention 2: Control group:In this group,0.3 milliliter per kilogram normal saline 0.9% (Saamen pharmaceutical company )with oxygen in the laryngotracheal region,will be flashed by McKenzie method(A kind of anesthesia method).</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:
All potential data can be shared after making peoples unrecognizable.

When:
Starting 6 months after publication .

To whom:
Documents will be available for people working in academic institutions and also people working in businesses.

Conditions:
There will be no specific limitations to the utilization of the data

Where to obtain:
Dr .Mahin Seyedhejazi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , seidhejazie@tbzmed.ac.ir

How to obtain:
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mahin Seyedhejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz pediatric hospital,sheshgelan street,Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 3526 2255</telephone>
        <email>seidhejazie@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mahin Seyedhejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz pediatric hospital,sheshgelan street,Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5136735886</zip>
        <telephone>+98 41 3526 2255</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>All children under the age of seven
With ASA grade,class I&amp;II and
Candidate for rigid bronchoscopy</inclusion_criteria>
      <agemin>1 day</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Head and neck anomalies
Feverish patients
Children with airway anomalies
Children with underlying disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of anesthesia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In this group after induction and laryngoscopy, the blend of lidocaine 2%(Caspian Taamin pharmaceutical company)0.3milliliter per kilogram with oxygen in the laryngotracheal area will be flashed by the McKenzie method(A kind of anesthesia method).</i_keyword>
      <i_keyword>Control group:In this group,0.3 milliliter per kilogram normal saline 0.9% (Saamen pharmaceutical company )with oxygen in the laryngotracheal region,will be flashed by McKenzie method(A kind of anesthesia method).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ease of bronchoscopy. Timepoint: Before induction, after induction, after flashing the desired solution every 3 minutes to 3 times and then every 5 minutes. Method of measurement: Based on the surgeon's consent, scoring as: Easy (0) - Medium (1) - Hard (2).</prim_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: Before induction, after induction, after flashing the desired solution every 3 minutes to 3 times and then every 5 minutes. Method of measurement: Mercury barometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before induction, after induction, after flashing the desired solution every 3 minutes to 3 times and then every 5 minutes. Method of measurement: Counting in each minutes.</prim_outcome>
      <prim_outcome>Saturation of peripheral oxygen. Timepoint: Before induction, after induction, after flashing the desired solution every 3 minutes to 3 times and then every 5 minutes. Method of measurement: Via the Pulse Oximeter.</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>2020-04-26</approval_date>
        <contact_name>Ethic Committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
