xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000267</url>
    </required_header>
    <id_info>
      <org_study_id>UCHBelgrade</org_study_id>
      <nct_id>NCT06000267</nct_id>
    </id_info>
    <brief_title>Incidence and Contributing Anthropometric Factors of Difficult Airway in Pediatric Surgical Patients</brief_title>
    <official_title>Incidence of Difficult Airway and Identification of Relevant Anthropometric Factors in Pediatric Patients Scheduled for Elective Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Childrens Hospital Belgrade</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Childrens Hospital Belgrade</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this prospective, observational study is to identify predictors of difficult mask&#xD;
        ventilation, direct laryngoscopy and intubation in pediatric patients scheduled for elective&#xD;
        surgery and to determine their incidence. As a final goal, the investigators will try to&#xD;
        define new scoring system for difficult airway prediction. Participants will be pediatric&#xD;
        patients age infant till school age. Participants will have their airway assessed one day&#xD;
        before surgery by taking anthropometric measurements of face and neck. After iv anesthesia&#xD;
        induction and application of muscle relaxant, the investigators will assess difficulty of&#xD;
        face mask ventilation by using grading from 0-4. Direct laryngoscopy will be performed with&#xD;
        Macintosh blade and experienced anesthesiologist will determine Cormack - Lehane score as&#xD;
        well as intubation difficulty score (IDS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will be divided into groups: up to 1 yrs of age, 1-2.9 yrs, 3-4.9, 5-6.9, and 7&#xD;
        yrs and older.&#xD;
  &#xD;
        The investigators will test predictive value, sensitivity and specificity of anthropometric&#xD;
        parameters used for airway assessment in pediatric patients, as well as gender, age, BMI, ASA&#xD;
        score.&#xD;
  &#xD;
        Anatomical parameters that will be measured the day before surgery: chin, inter - incisor&#xD;
        gap, hyomental distance (HMD), hyoid - thyroid distance (HT), neck circumference, neck&#xD;
        length, neck extension, lower lip to chin distance (LCD), tragus to chin distance (TMA),&#xD;
        thyromental distance (TMD), sternomental distance (SMD).&#xD;
  &#xD;
        Mallampati test will be performed in children older than 5 years and best oropharyngeal view&#xD;
        (BOV) will be determined for younger children. Colorado Pediatric Airway Score (COPUR) will&#xD;
        be calculated.&#xD;
  &#xD;
        All patients will be premedicated with midazolam 0.5 mg/kg orally, 30 minutes before&#xD;
        intervention or 0.1 mg/kg iv. Anesthesia induction will be intravenous: thiopentone 5 mg/kg&#xD;
        or propofol 2.5 mg/kg, fentanyl 3 mcg/kg and non depolarizing muscle relaxant rocuronium 1&#xD;
        mg/kg or cis-atracurium 0.15 mg/kg. Face mask ventilation will be quantified as grade 0-4.&#xD;
        Anesthesia maintenance will be intravenous or inhalatory depending on anesthesiologists&#xD;
        decision. Patients will be intubated with Macintosh blade in the supine position, without&#xD;
        additional elevation of occipital part of the head. Difficult laryngoscopy is defined as CL&#xD;
        grade III and IV and they predict difficult endotracheal intubation. Intubation difficulty&#xD;
        score will be used to asses intubation. Intubation difficulty will be defined by IDS -&#xD;
        intubation difficulty score &gt; 5.&#xD;
  &#xD;
        Standard procedures will be performed in case of difficult mask ventilation and intubation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 10, 2022</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>incidence of difficult mask ventilation and intubation</measure>
      <time_frame>one year</time_frame>
      <description>Determination of grade 3 and 4 of mask ventilation incidence in different age groups of children and incidence of difficult intubation defined as intubation difficultly score &gt;5</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identification of anthropometric parameters of face and neck which determine difficult airway in children</measure>
      <time_frame>one year</time_frame>
      <description>Identification of preoperative measurements of face and neck determining difficult face mask ventilation and intubation</description>
    </secondary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Difficult Airway</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intubation</intervention_name>
      <description>All the patients will be ventilated with face mask and intubated before elective surgery</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient will be divided in 5 groups according to age: infants, children from 1 - 2,9 years,&#xD;
          3 - 4,9 years, 5 - 6,9 years and older than 7 years.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pediatric patients from one month to 14 years old scheduled for elective surgery in&#xD;
               general endotracheal anesthesia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Congenital syndromes which include difficult airway (Pierre Robin, Goldenhar syndrome,&#xD;
               Treacher Collins syn, Down syn, Edwards, Arthrogryposis, Apart syn etc.), craniofacial&#xD;
               dysmorphia, ENT, maxillofacial and cardiac surgery patients, patients with resent&#xD;
               respiratory infections&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>28 Days</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ivana Petrov, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University children hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ivana Petrov, MD</last_name>
      <phone>64 152 5959</phone>
      <phone_ext>+381</phone_ext>
      <email>kikapetrov75@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Children hospital</name>
        <address>
          <city>Belgrade</city>
          <zip>11000</zip>
          <country>Serbia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ivana Petrov, MD</last_name>
        <phone>641525959</phone>
        <phone_ext>+381</phone_ext>
        <email>kikapetrov75@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Serbia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Childrens Hospital Belgrade</investigator_affiliation>
      <investigator_full_name>Ivana Petrov Bojicic</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>children</keyword>
    <keyword>intubation</keyword>
    <keyword>face mask ventilation</keyword>
    <keyword>best oropharyngeal view</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000267
  org study id: UCHBelgrade
  nct id: NCT06000267
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective, observational study is to identify predictors of difficult mask
        ventilation, direct laryngoscopy and intubation in pediatric patients scheduled for elective
        surgery and to determine their incidence. As a final goal, the investigators will try to
        define new scoring system for difficult airway prediction. Participants will be pediatric
        patients age infant till school age. Participants will have their airway assessed one day
        before surgery by taking anthropometric measurements of face and neck. After iv anesthesia
        induction and application of muscle relaxant, the investigators will assess difficulty of
        face mask ventilation by using grading from 0-4. Direct laryngoscopy will be performed with
        Macintosh blade and experienced anesthesiologist will determine Cormack - Lehane score as
        well as intubation difficulty score (IDS).
  Participants will be divided into groups: up to 1 yrs of age, 1-2.9 yrs, 3-4.9, 5-6.9, and 7
        yrs and older.
  
        The investigators will test predictive value, sensitivity and specificity of anthropometric
        parameters used for airway assessment in pediatric patients, as well as gender, age, BMI, ASA
        score.
  
        Anatomical parameters that will be measured the day before surgery: chin, inter - incisor
        gap, hyomental distance (HMD), hyoid - thyroid distance (HT), neck circumference, neck
        length, neck extension, lower lip to chin distance (LCD), tragus to chin distance (TMA),
        thyromental distance (TMD), sternomental distance (SMD).
  
        Mallampati test will be performed in children older than 5 years and best oropharyngeal view
        (BOV) will be determined for younger children. Colorado Pediatric Airway Score (COPUR) will
        be calculated.
  
        All patients will be premedicated with midazolam 0.5 mg/kg orally, 30 minutes before
        intervention or 0.1 mg/kg iv. Anesthesia induction will be intravenous: thiopentone 5 mg/kg
        or propofol 2.5 mg/kg, fentanyl 3 mcg/kg and non depolarizing muscle relaxant rocuronium 1
        mg/kg or cis-atracurium 0.15 mg/kg. Face mask ventilation will be quantified as grade 0-4.
        Anesthesia maintenance will be intravenous or inhalatory depending on anesthesiologists
        decision. Patients will be intubated with Macintosh blade in the supine position, without
        additional elevation of occipital part of the head. Difficult laryngoscopy is defined as CL
        grade III and IV and they predict difficult endotracheal intubation. Intubation difficulty
        score will be used to asses intubation. Intubation difficulty will be defined by IDS -
        intubation difficulty score > 5.
  
        Standard procedures will be performed in case of difficult mask ventilation and intubation.
  observational model: Other
  time perspective: Prospective
  measure: incidence of difficult mask ventilation and intubation
  time frame: one year
  description: Determination of grade 3 and 4 of mask ventilation incidence in different age groups of children and incidence of difficult intubation defined as intubation difficultly score >5
  measure: Identification of anthropometric parameters of face and neck which determine difficult airway in children
  time frame: one year
  description: Identification of preoperative measurements of face and neck determining difficult face mask ventilation and intubation
  intervention type: Procedure
  intervention name: Intubation
  description: All the patients will be ventilated with face mask and intubated before elective surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 28 Days
  maximum age: 14 Years
  healthy volunteers: No
  last name: Ivana Petrov, MD
  role: Principal Investigator
  affiliation: University children hospital
  last name: Ivana Petrov, MD
  phone: 64 152 5959
  phone ext: +381
  email: kikapetrov75@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Serbia
  responsible party type: Principal Investigator
  investigator affiliation: University Childrens Hospital Belgrade
  investigator full name: Ivana Petrov Bojicic
  investigator title: Associate Professor
  sharing ipd: No