<?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>IRCT20180416039326N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-21</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of epistaxis in nasal tracheal intubation With finger guidance and conventional method</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the severity of epistaxis between the finger guided and conventional technique of  nasotracheal intubation in patients undergoing maxillofacial surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42274</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients who entered the study were randomly divided into two groups using computer software (Random allocation software), Blinding description: The person who performed the intubation had no role in gathering information. 
The person who assessing intubation complications and observer who collecting information were unaware of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Epistaxis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The dominant or more open nostril (Patent) was selected by alternating finger pressure on the left and right nasal fins and asking the patient to take a slow breath. Then nasal tube number 7 in women and number 7.5 in men were used for intubation. The endotracheal tube was then inserted through the dominant (more open) nostril and directed to the pharynx. In the first group, the tube was guided blindly forward until the endotracheal tube was seen in the pharyngeal area following direct laryngoscopy with a  Macintosh laryngoscope. Intervention 2: Intervention group: In the second group, after the finger of the non-dominant hand enters the mouth and then continues to the back of the soft palate in the nasopharynx, We move the endotracheal tube forward So that after the tip of the endotracheal tube comes in contact with the tip of the finger, the end of the endotracheal tube path is guided by the finger and slowly until the endotracheal tube enters the oropharyngeal space. Then the endotracheal tube is guided to the endotracheal and if the accuracy of the intubation is ensured, the tube is fixed.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I will decide until the end of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Shetabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Hospital, Sofe Boulevard</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3822 2532</telephone>
        <email>hamidshetabi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Shetabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Hospital - Sofe Boulevard</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3822 2532</telephone>
        <email>hamidshetabi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Candidate for elective maxillofacial surgery under general anesthesia
ASA One and Two
Informed consent to participate in the study
Age: 16 to 65 years old</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of bleeding disorders
History of nasopharyngeal masses
History of head, face and fracture trauma of the nose and cheekbones
Taking any anticoagulant
History of any surgery or manipulation of the nose</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Epistaxis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The dominant or more open nostril (Patent) was selected by alternating finger pressure on the left and right nasal fins and asking the patient to take a slow breath. Then nasal tube number 7 in women and number 7.5 in men were used for intubation. The endotracheal tube was then inserted through the dominant (more open) nostril and directed to the pharynx. In the first group, the tube was guided blindly forward until the endotracheal tube was seen in the pharyngeal area following direct laryngoscopy with a  Macintosh laryngoscope.</i_keyword>
      <i_keyword>Intervention group: In the second group, after the finger of the non-dominant hand enters the mouth and then continues to the back of the soft palate in the nasopharynx, We move the endotracheal tube forward So that after the tip of the endotracheal tube comes in contact with the tip of the finger, the end of the endotracheal tube path is guided by the finger and slowly until the endotracheal tube enters the oropharyngeal space. Then the endotracheal tube is guided to the endotracheal and if the accuracy of the intubation is ensured, the tube is fixed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of bleeding in the throat. Timepoint: After intubation through the nose. Method of measurement: See the throat.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-10</approval_date>
        <contact_name>Ethics committee of Isfahan Universiti of Medical Sciences</contact_name>
        <contact_address>Sefa Boulevard Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
