<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/NCT02993692</url>
  </required_header>
  <id_info>
    <org_study_id>Asozkan</org_study_id>
    <nct_id>NCT02993692</nct_id>
  </id_info>
  <brief_title>Nasotracheal Intubation in Children for Outpatient Dental Surgery</brief_title>
  <official_title>Nasotracheal Intubation in Children for Outpatient Dental Surgery: Is Fiberoptic Bronchoscopy Useful?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of study was to compare the hemodynamic responses and adverse events associated with&#xD;
      nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct laryngoscope&#xD;
      (DLS) in children undergoing general anesthesia for outpatient dental surgery. Eighty&#xD;
      children (aged 5-15 years) were scheduled to undergo outpatient dental surgery under general&#xD;
      anesthesia and who required nasotracheal intubation were included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators obtained confirmation from the Inonu University Medical Faculty Hospital Ethics&#xD;
      Committee (2015/101) and written informed consent from the guardians of all 80 children.&#xD;
      These children, who had a American Society of Anesthesia physical status of I-II, had a&#xD;
      Mallampati Score of 1-2, were aged 5-15 years, were scheduled to undergo outpatient dental&#xD;
      surgery under general anesthesia, and required nasotracheal intubation were included in this&#xD;
      prospective and randomized study. Exclusion criteria included the following: the patient's&#xD;
      refusal for study consent, active upper respiratory infection, airway abnormalities, nasal&#xD;
      mass or nasal injury, bleeding disorders, allergies to anesthetics, uncontrolled&#xD;
      hypertension, morbid obesity, hepatic or renal failure, cardiovascular diseases, a history of&#xD;
      nasopharyngeal surgery and those who were difficult to intubate. Children were randomly&#xD;
      assigned into the direct laryngoscopy group (n = 40) or the fiberoptic bornchoscopy group (n&#xD;
      = 40) according to a computer-randomized table. General anesthesia was administered to&#xD;
      children due to the learning difficulties. The number of models was decided by a statistical&#xD;
      power analysis after the conclusions from the pretest were obtained. All children fasted at&#xD;
      least for 6 h before surgery, and the oral intake of clear fluids was restricted for 2-3 h.&#xD;
      Premedication of midazolam (0.5 mg/kg) was orally administered in apple juice (0.5 mL/kg of&#xD;
      body weight) 1 h prior to anesthesia. After being admitted to the operating room, the&#xD;
      patient's systolic blood pressure (SBP) and heart rate (HR) were continually monitored with a&#xD;
      multichannel physiologic monitor and the baseline values for SBP and HR were recorded. Thirty&#xD;
      min before the intubation attempt, the nasal mucosa of both nostrils were anesthetized with a&#xD;
      topical vasoconstrictor (0.05% xylometazoline spray, and 2% lidocaine 1 mL two times in each&#xD;
      nostril) (9) to attenuate cardiovascular responses and adverse events in all children.&#xD;
      Anesthesia was induced with 8% sevoflurane with eight deep breaths via a face mask, and the&#xD;
      patient was maintained on 4% end-tidal sevoflurane, fentanyl 2 µr/kg and rocuronium 0.6&#xD;
      mg/kg. NTI was achieved 2 min after rocuronium injection. The more patent nostril was&#xD;
      selected for intubation. An experienced anesthetist performed all intubations in the study&#xD;
      and an assistant applied the maneuvers (jaw trust) and evaluated the patient during the&#xD;
      postoperative visits. All NTIs, both DLS and FOB, were conducted by the same experienced&#xD;
      anesthetist (the anesthetist had performed DLS and the FOB nasal intubation in more than 150&#xD;
      patients, including in at least 100 children before the study). A study nurse documented the&#xD;
      anesthetic data and timing. In the DLS group, the spiral tube was inserted into the nose and&#xD;
      intubated with a Macintosh laryngoscope according to conventional procedures using Magill&#xD;
      forceps. In the FOB group, NTI was conducted using an FOB with an outer diameter of 3.1 mm&#xD;
      through the selected clear nasal passage with a spiral tracheal tube. The appropriate size of&#xD;
      the tracheal tube for a child was determined with the following formula (10): Internal&#xD;
      diameter (mm) = age/3 + 3.5 in both groups. The same type of tube was used in each group.&#xD;
      Before intubation, enough lidocaine gel was placed on the tracheal tube, and the FOB was&#xD;
      guided into patients with a suitable spiral tracheal tube. All tracheal tubes were cuffed and&#xD;
      heat-softened in warm normal saline and lubricated to reduce mechanic stimuli to airway&#xD;
      structures. During the intubation, the head of the patient was the in supine position, and an&#xD;
      assistant applied a jaw thrust for opening the nasopharyngeal passage and improved the image&#xD;
      in all patients in the FOB group. If indicated (a suboptimal laryngeal view or resistance in&#xD;
      passing of the tracheal tube), anterior laryngeal pressure and tongue withdrawal by digital&#xD;
      traction was performed to improve the laryngeal field of view. When the glottis was clearly&#xD;
      visible, the FOB was advanced through the vocal cords, and jaw thrust movement was released.&#xD;
      To prevent the stimulation of the carina, the tube was placed 4 cm below the glottis, sliding&#xD;
      over the FOB. Intubation was verified with the FOB, and end-tidal CO2 concentrations at 35-40&#xD;
      mmHg were monitored. A throat pack was inserted by the anesthetist after the measurements&#xD;
      were taken. Anesthesia was maintained with 2% sevoflurane and 50% N20 in oxygen with 1.5 l&#xD;
      min-1 fresh gas flow and 35-40 mmHg end-tidal CO2 concentrations. Isolyte-P was administered&#xD;
      at rate of 15 mL/kg/h IV, and acetaminophen (15 mg kg-1) was infused for postoperative&#xD;
      analgesia in all children.&#xD;
&#xD;
      SBP and HR were recorded at baseline, after induction of anesthesia, at the time of&#xD;
      intubation, and 1, 3 and 5 min after intubation. The intubation time (the time from when&#xD;
      manual ventilation with a facemask stopped to restarting ventilation via the nasotracheal&#xD;
      tube and when carbon dioxide (CO2) was detected by capnography) was recorded by another&#xD;
      anesthetist with a digital stopwatch. Nose bleeding after intubation (epistaxis),&#xD;
      laryngospasms, bradycardia (HR&lt;65 beat min-1), hypoxic episodes (SpO2&lt;90%) and the surgery&#xD;
      type were also recorded. Adverse events (hoarseness, sore throat) were assessed 24 h after&#xD;
      surgery. If a sore throat developed, additional analgesics were not administered. If&#xD;
      bradycardia or desaturation (SpO2&lt;90%) occurred for more than 2 min, the intubation was&#xD;
      interrupted, and patients were ventilated with 100% oxygen and were administered IV atropine&#xD;
      (5-10 µg / kg).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 4, 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>From Begining of Anesthesia induction to 5th minutes of intubation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>From Begining of Anesthesia induction to 5th minutes of intubation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>within the first 24 hour after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Nasotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>fiberoptic bronchoscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>I want to see the difference between the two group about hemodynamic and intraoculer pressure responses about fiberoptic bronchoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>direct laryngoscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>I want to see the difference between the two group about hemodynamic and intraoculer pressure responses about direct laryngoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Direct laryngoscopy and fiberoptic bronchoscopy</intervention_name>
    <description>These devices is used in endotracheal intubation and tonopen for measuring of intraoculer pressure. I want to see whcih is better.</description>
    <arm_group_label>direct laryngoscopy</arm_group_label>
    <arm_group_label>fiberoptic bronchoscopy</arm_group_label>
    <other_name>tonopen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status of I-II, had a Mallampati Score of 1-2, were aged 5-15 years, were&#xD;
             scheduled to undergo outpatient dental surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient's refusal for study consent, active upper respiratory infection, airway&#xD;
             abnormalities, nasal mass or nasal injury, bleeding disorders, allergies to&#xD;
             anesthetics, uncontrolled hypertension, morbid obesity, hepatic or renal failure,&#xD;
             cardiovascular diseases, a history of nasopharyngeal surgery and those who were&#xD;
             difficult to intubate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Ahmet Selim Ozkan</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>direct laryngoscopy</keyword>
  <keyword>fiberopitc bronchoscopy</keyword>
  <keyword>nasotracheal intubation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02993692/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02993692
org study id: Asozkan
nct id: NCT02993692
lead sponsor: 
has dmc: No
The aim of study was to compare the hemodynamic responses and adverse events associated with
      nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct laryngoscope
      (DLS) in children undergoing general anesthesia for outpatient dental surgery. Eighty
      children (aged 5-15 years) were scheduled to undergo outpatient dental surgery under general
      anesthesia and who required nasotracheal intubation were included.
Investigators obtained confirmation from the Inonu University Medical Faculty Hospital Ethics
      Committee (2015/101) and written informed consent from the guardians of all 80 children.
      These children, who had a American Society of Anesthesia physical status of I-II, had a
      Mallampati Score of 1-2, were aged 5-15 years, were scheduled to undergo outpatient dental
      surgery under general anesthesia, and required nasotracheal intubation were included in this
      prospective and randomized study. Exclusion criteria included the following: the patient's
      refusal for study consent, active upper respiratory infection, airway abnormalities, nasal
      mass or nasal injury, bleeding disorders, allergies to anesthetics, uncontrolled
      hypertension, morbid obesity, hepatic or renal failure, cardiovascular diseases, a history of
      nasopharyngeal surgery and those who were difficult to intubate. Children were randomly
      assigned into the direct laryngoscopy group (n = 40) or the fiberoptic bornchoscopy group (n
      = 40) according to a computer-randomized table. General anesthesia was administered to
      children due to the learning difficulties. The number of models was decided by a statistical
      power analysis after the conclusions from the pretest were obtained. All children fasted at
      least for 6 h before surgery, and the oral intake of clear fluids was restricted for 2-3 h.
      Premedication of midazolam (0.5 mg/kg) was orally administered in apple juice (0.5 mL/kg of
      body weight) 1 h prior to anesthesia. After being admitted to the operating room, the
      patient's systolic blood pressure (SBP) and heart rate (HR) were continually monitored with a
      multichannel physiologic monitor and the baseline values for SBP and HR were recorded. Thirty
      min before the intubation attempt, the nasal mucosa of both nostrils were anesthetized with a
      topical vasoconstrictor (0.05% xylometazoline spray, and 2% lidocaine 1 mL two times in each
      nostril) (9) to attenuate cardiovascular responses and adverse events in all children.
      Anesthesia was induced with 8% sevoflurane with eight deep breaths via a face mask, and the
      patient was maintained on 4% end-tidal sevoflurane, fentanyl 2 µr/kg and rocuronium 0.6
      mg/kg. NTI was achieved 2 min after rocuronium injection. The more patent nostril was
      selected for intubation. An experienced anesthetist performed all intubations in the study
      and an assistant applied the maneuvers (jaw trust) and evaluated the patient during the
      postoperative visits. All NTIs, both DLS and FOB, were conducted by the same experienced
      anesthetist (the anesthetist had performed DLS and the FOB nasal intubation in more than 150
      patients, including in at least 100 children before the study). A study nurse documented the
      anesthetic data and timing. In the DLS group, the spiral tube was inserted into the nose and
      intubated with a Macintosh laryngoscope according to conventional procedures using Magill
      forceps. In the FOB group, NTI was conducted using an FOB with an outer diameter of 3.1 mm
      through the selected clear nasal passage with a spiral tracheal tube. The appropriate size of
      the tracheal tube for a child was determined with the following formula (10): Internal
      diameter (mm) = age/3 + 3.5 in both groups. The same type of tube was used in each group.
      Before intubation, enough lidocaine gel was placed on the tracheal tube, and the FOB was
      guided into patients with a suitable spiral tracheal tube. All tracheal tubes were cuffed and
      heat-softened in warm normal saline and lubricated to reduce mechanic stimuli to airway
      structures. During the intubation, the head of the patient was the in supine position, and an
      assistant applied a jaw thrust for opening the nasopharyngeal passage and improved the image
      in all patients in the FOB group. If indicated (a suboptimal laryngeal view or resistance in
      passing of the tracheal tube), anterior laryngeal pressure and tongue withdrawal by digital
      traction was performed to improve the laryngeal field of view. When the glottis was clearly
      visible, the FOB was advanced through the vocal cords, and jaw thrust movement was released.
      To prevent the stimulation of the carina, the tube was placed 4 cm below the glottis, sliding
      over the FOB. Intubation was verified with the FOB, and end-tidal CO2 concentrations at 35-40
      mmHg were monitored. A throat pack was inserted by the anesthetist after the measurements
      were taken. Anesthesia was maintained with 2% sevoflurane and 50% N20 in oxygen with 1.5 l
      min-1 fresh gas flow and 35-40 mmHg end-tidal CO2 concentrations. Isolyte-P was administered
      at rate of 15 mL/kg/h IV, and acetaminophen (15 mg kg-1) was infused for postoperative
      analgesia in all children.

      SBP and HR were recorded at baseline, after induction of anesthesia, at the time of
      intubation, and 1, 3 and 5 min after intubation. The intubation time (the time from when
      manual ventilation with a facemask stopped to restarting ventilation via the nasotracheal
      tube and when carbon dioxide (CO2) was detected by capnography) was recorded by another
      anesthetist with a digital stopwatch. Nose bleeding after intubation (epistaxis),
      laryngospasms, bradycardia (HR<65 beat min-1), hypoxic episodes (SpO2<90%) and the surgery
      type were also recorded. Adverse events (hoarseness, sore throat) were assessed 24 h after
      surgery. If a sore throat developed, additional analgesics were not administered. If
      bradycardia or desaturation (SpO2<90%) occurred for more than 2 min, the intubation was
      interrupted, and patients were ventilated with 100% oxygen and were administered IV atropine
      (5-10 µg / kg).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Systolic blood pressure
time frame: From Begining of Anesthesia induction to 5th minutes of intubation
measure: Heart rate
time frame: From Begining of Anesthesia induction to 5th minutes of intubation
measure: Adverse events
time frame: within the first 24 hour after surgery
arm group label: fiberoptic bronchoscopy
arm group type: Other
description: I want to see the difference between the two group about hemodynamic and intraoculer pressure responses about fiberoptic bronchoscopy.
arm group label: direct laryngoscopy
arm group type: Other
description: I want to see the difference between the two group about hemodynamic and intraoculer pressure responses about direct laryngoscopy.
intervention type: Device
intervention name: Direct laryngoscopy and fiberoptic bronchoscopy
description: These devices is used in endotracheal intubation and tonopen for measuring of intraoculer pressure. I want to see whcih is better.
arm group label: direct laryngoscopy
arm group label: fiberoptic bronchoscopy
other name: tonopen
criteria: 
gender: All
minimum age: 5 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Ahmet Selim Ozkan
investigator title: M.D.
sharing ipd: No
provided document: 