<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/NCT01708967</url>
  </required_header>
  <id_info>
    <org_study_id>OTSMVSSCM</org_study_id>
    <nct_id>NCT01708967</nct_id>
  </id_info>
  <brief_title>Trial of New Pretreatment Method in Transnasal Endoscopy</brief_title>
  <acronym>RTNPMTNE</acronym>
  <official_title>One-time Spray of Epinephrine (1cc) Plus 4% Lidocaine (4cc) is Sufficient Pretreatment Method for the Preparation of Transnasal Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chuncheon Sacred Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chuncheon Sacred Heart Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study designed for compare efficacy of following two anesthetic method for transnasal&#xD;
      endoscopy&#xD;
&#xD;
        -  &quot;Catheter-free method&quot;&#xD;
&#xD;
        -  &quot;Catheter-insertion method&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Check of the medical history (both method)&#xD;
&#xD;
             1. underlying systemic disease&#xD;
&#xD;
             2. drug allergy&#xD;
&#xD;
             3. anticoagulant or antiplatelet use&#xD;
&#xD;
        2. Premedication (both method)&#xD;
&#xD;
             1. taking premedication contain dimethylpolysiloxane, pronase, sodium bicarbonate for&#xD;
                improved endoscopic visualization&#xD;
&#xD;
             2. spraying naphazolin acetate into nasal cavity for decrease secretion&#xD;
&#xD;
        3. Different anesthetic method for transnasal endoscopy&#xD;
&#xD;
             1. &quot;Catheter-free method&quot; : spraying epinephrine into nasal cavity&#xD;
&#xD;
             2. &quot;Catheter-insertion method&quot; : spraying both epinephrine and lidocaine into nasal&#xD;
                cavity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">August 2009</completion_date>
  <primary_completion_date type="Actual">August 2009</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success Rate of Transnasal Endoscopy</measure>
    <time_frame>During transnasal endoscopy, up to 1 hours</time_frame>
    <description>We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.&#xD;
We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vital Signs</measure>
    <time_frame>before, during, and after transnasal endoscopy</time_frame>
    <description>Blood pressure, heart rate, and O2 saturation were assessed.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction</measure>
    <time_frame>after transnasal endoscopy</time_frame>
    <description>Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pretreatment Method of Transnasal Endoscopy</condition>
  <arm_group>
    <arm_group_label>Catheter-free method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We explored success rate, side effects, and vital signs in patients with catether-free method.&#xD;
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Catheter insertion method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pretreatment method for transnasal endoscopy</intervention_name>
    <description>Catheter-free method : The patient then takes simethicone (10cc). After that, the nasal cavity is sprayed with epinephrine (1cc) and lidocaine HCL (4%, 4cc).&#xD;
Catheter inesertion method: After preparation steps the same as in the 'catheter-free' method, a 14 Fr. flexible catheter is coated with 2% lidocaine HCL gel and 8% lidocaine HCL spray. After that, the catheter is inserted into the patient's nasal cavity, and maintained about 1 minute for anesthesia. A 16 Fr. catheter is prepared by the same method with as the 14Fr. catheter. After the 14 Fr. cathter has been removed from the patient's nasal cavity, the 16 Fr. catheter is inserted into the patient's nasal cavity.</description>
    <arm_group_label>Catheter insertion method</arm_group_label>
    <arm_group_label>Catheter-free method</arm_group_label>
    <other_name>Catheter-free method/Cathter insertion method</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Routine check-up patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  nasal operation, an allergy, a possibility of hemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ki Tae Suk, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital</name>
      <address>
        <city>Chuncheon</city>
        <zip>200-704</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>November 9, 2013</results_first_submitted>
  <results_first_submitted_qc>January 29, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 13, 2014</results_first_posted>
  <last_update_submitted>January 29, 2014</last_update_submitted>
  <last_update_submitted_qc>January 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chuncheon Sacred Heart Hospital</investigator_affiliation>
    <investigator_full_name>Ki Tae Suk</investigator_full_name>
    <investigator_title>doctor, assistant professor</investigator_title>
  </responsible_party>
  <keyword>transnasal endoscopy</keyword>
  <keyword>pretreatment method</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Catheter-free Method</title>
          <description>We explored success rate, side effects, and vital signs in patients with one-time spray method.&#xD;
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)&#xD;
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.&#xD;
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.</description>
        </group>
        <group group_id="P2">
          <title>Catheter-insertion Method</title>
          <description>We explored success rate, side effects, and vital signs in patients with spray+catheter method.&#xD;
Intervention: use both spray and catheter&#xD;
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.&#xD;
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Catheter-free Method</title>
          <description>We explored success rate, side effects, and vital signs in patients with one-time spray method.&#xD;
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)</description>
        </group>
        <group group_id="B2">
          <title>Catheter-insertion Method</title>
          <description>We explored success rate, side effects, and vital signs in patients with spray+catheter method.&#xD;
Intervention: use both spray and catheter</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.4" spread="10.8"/>
                    <measurement group_id="B2" value="59.7" spread="12.3"/>
                    <measurement group_id="B3" value="59.00" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Vital Signs</title>
        <description>Blood pressure, heart rate, and O2 saturation were assessed.</description>
        <time_frame>before, during, and after transnasal endoscopy</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Satisfaction</title>
        <description>Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.</description>
        <time_frame>after transnasal endoscopy</time_frame>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Success Rate of Transnasal Endoscopy</title>
        <description>We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.&#xD;
We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.</description>
        <time_frame>During transnasal endoscopy, up to 1 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Catheter-free Method</title>
            <description>We explored success rate, side effects, and vital signs in patients with one-time spray method.&#xD;
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)&#xD;
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.&#xD;
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.</description>
          </group>
          <group group_id="O2">
            <title>Catheter-insertion Method</title>
            <description>We explored success rate, side effects, and vital signs in patients with spray+catheter method.&#xD;
Intervention: use both spray and catheter&#xD;
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.&#xD;
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.</description>
          </group>
        </group_list>
        <measure>
          <title>Success Rate of Transnasal Endoscopy</title>
          <description>We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.&#xD;
We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.</description>
          <units>percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" lower_limit="80" upper_limit="96"/>
                    <measurement group_id="O2" value="88" lower_limit="80" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Catheter-free Method</title>
          <description>We explored success rate, side effects, and vital signs in patients with one-time spray method.&#xD;
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)&#xD;
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.&#xD;
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.</description>
        </group>
        <group group_id="E2">
          <title>Catheter-insertion Method</title>
          <description>We explored success rate, side effects, and vital signs in patients with spray+catheter method.&#xD;
Intervention: use both spray and catheter&#xD;
pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.&#xD;
spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <limitations_and_caveats>A limitation of this study was the small number of patients; n = 93 is insufficient to conclusively generalize the efficiency of the catheter-free method.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Ki Tae Suk</name_or_title>
      <organization>Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea</organization>
      <phone>+82-33-240-5826</phone>
      <email>ktsuk@hallym.ac.kr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01708967
org study id: OTSMVSSCM
nct id: NCT01708967
lead sponsor: 
has dmc: Yes
This study designed for compare efficacy of following two anesthetic method for transnasal
      endoscopy

        -  "Catheter-free method"

        -  "Catheter-insertion method"
1. Check of the medical history (both method)

             1. underlying systemic disease

             2. drug allergy

             3. anticoagulant or antiplatelet use

        2. Premedication (both method)

             1. taking premedication contain dimethylpolysiloxane, pronase, sodium bicarbonate for
                improved endoscopic visualization

             2. spraying naphazolin acetate into nasal cavity for decrease secretion

        3. Different anesthetic method for transnasal endoscopy

             1. "Catheter-free method" : spraying epinephrine into nasal cavity

             2. "Catheter-insertion method" : spraying both epinephrine and lidocaine into nasal
                cavity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success Rate of Transnasal Endoscopy
time frame: During transnasal endoscopy, up to 1 hours
description: We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.
We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity.
measure: Vital Signs
time frame: before, during, and after transnasal endoscopy
description: Blood pressure, heart rate, and O2 saturation were assessed.
measure: Satisfaction
time frame: after transnasal endoscopy
description: Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.
arm group label: Catheter-free method
arm group type: Experimental
description: We explored success rate, side effects, and vital signs in patients with catether-free method.
Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)
arm group label: Catheter insertion method
arm group type: Experimental
description: We explored success rate, side effects, and vital signs in patients with catether insertion method : use both spray and catheter
intervention type: Procedure
intervention name: pretreatment method for transnasal endoscopy
description: Catheter-free method : The patient then takes simethicone (10cc). After that, the nasal cavity is sprayed with epinephrine (1cc) and lidocaine HCL (4%, 4cc).
Catheter inesertion method: After preparation steps the same as in the 'catheter-free' method, a 14 Fr. flexible catheter is coated with 2% lidocaine HCL gel and 8% lidocaine HCL spray. After that, the catheter is inserted into the patient's nasal cavity, and maintained about 1 minute for anesthesia. A 16 Fr. catheter is prepared by the same method with as the 14Fr. catheter. After the 14 Fr. cathter has been removed from the patient's nasal cavity, the 16 Fr. catheter is inserted into the patient's nasal cavity.
arm group label: Catheter insertion method
arm group label: Catheter-free method
other name: Catheter-free method/Cathter insertion method
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ki Tae Suk, M.D.,Ph.D.
role: Principal Investigator
affiliation: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chuncheon Sacred Heart Hospital
investigator full name: Ki Tae Suk
investigator title: doctor, assistant professor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: A limitation of this study was the small number of patients; n = 93 is insufficient to conclusively generalize the efficiency of the catheter-free method.
point of contact: 