<?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>IRCT20211028052894N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-13</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the Impact of Applying Ipratropium Bromide Inhalation on Cough Following Bronchoscopy in Children</public_title>
      <acronym>SIIBCS</acronym>
      <scientific_title>Investigating the Impact of Applying Ipratropium Bromide Inhalation on Cough Following Bronchoscopy in Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60000</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: according to the limited society and lack of similar study, the pilot sampling method is used to determine sample size, as it is intended for the control group of 30 and for the test group of 30, Randomization description: the data collection method is a field and questionnaire and interview is used. In this study, children in this study will be divided into two testing and control groups, 30 in the test group and 30 in the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Investigating the Impact of Applying Ipratropium Bromide Inhalation on Reducing Cough Following Bronchoscopy in Children.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, 30 eligible kindergartens will be selected as the intervention group using permutation blocks. In addition to standard care, 2 puffs will be performed every 20 minutes for 3 ipratropyum bromide inhaled by Demiar one hour before surgery and will be interviewed and observed in terms of coughing rate.For this purpose, a nurse colleague without knowing the prescription of the drug is requested to remember the severity and number of coughs, the number of breathing, heart rate and blood pressure of the patient at the specified times during and immediately after the completion of the work and the patient's entry into the recovery every 30 minutes. Also, the need for suctioning during surgery and after the patient's arrival to recovery at similar times should be remembered. Intervention 2: Control group: 30 eligible kindergartens will be selected as the control group using permutation blocks, the control group will be treated with standard care and medications before, during and after bronchoscopy and will be interviewed and observed in terms of cough rate. For this purpose, a nurse colleague is requested without the knowledge of the prescription of the drug.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is no data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Amin Tavazo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Shykhi 4 Alley</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7185998181</zip>
        <telephone>+98 71 3632 1496</telephone>
        <email>mohammad.amin.tavazo.1990@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Amin Tavazo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Sheykhi  4alley</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7185998171</zip>
        <telephone>+98 71 3632 1496</telephone>
        <email>mohammad.amin.tavazo.1990@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria include the age between 2 and 12 years
The inclusion under  Bronchoscopy</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The exit criteria include the use of  Inhalation and oral corticosteroids, heart disease, drug sensitivity,
and the existence of smoking and smoking in</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>0BJ08ZZ</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inspection of Tracheobronchial Tree, Via Natural or Artificial Opening Endoscopic</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, 30 eligible kindergartens will be selected as the intervention group using permutation blocks. In addition to standard care, 2 puffs will be performed every 20 minutes for 3 ipratropyum bromide inhaled by Demiar one hour before surgery and will be interviewed and observed in terms of coughing rate.For this purpose, a nurse colleague without knowing the prescription of the drug is requested to remember the severity and number of coughs, the number of breathing, heart rate and blood pressure of the patient at the specified times during and immediately after the completion of the work and the patient's entry into the recovery every 30 minutes. Also, the need for suctioning during surgery and after the patient's arrival to recovery at similar times should be remembered.</i_keyword>
      <i_keyword>Control group: 30 eligible kindergartens will be selected as the control group using permutation blocks, the control group will be treated with standard care and medications before, during and after bronchoscopy and will be interviewed and observed in terms of cough rate. For this purpose, a nurse colleague is requested without the knowledge of the prescription of the drug.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number  cough. Timepoint: The recovery and immediately after the patient " s arrival at the recovery, then every 30 minutes will be assessed number of coughs . Method of measurement: count number of coughs by nurse.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Respiratory rate. Timepoint: During and immediately after finishing the work and entering the patient to the recovery is remembered every 30 minutes. Method of measurement: Measures and notes at the specified times by the nurse.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: During and immediately after finishing the work and entering the patient to the recovery is remembered every 30 minutes. Method of measurement: Measures and notes at the specified times by the nurse.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: During and immediately after finishing the work and entering the patient to the recovery is remembered every 30 minutes. Method of measurement: Measures and notes at the specified times by the nurse.</sec_outcome>
      <sec_outcome>The need for suctioning. Timepoint: During and immediately after finishing the work and entering the patient to the recovery is remembered every 30 minutes. Method of measurement: Measures and notes at the specified times by the nurse.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-20</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>west sheykhi shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
