<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/NCT02219464</url>
  </required_header>
  <id_info>
    <org_study_id>130627</org_study_id>
    <nct_id>NCT02219464</nct_id>
  </id_info>
  <brief_title>Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients</brief_title>
  <official_title>Nasopharyngeal Versus Nasal Cannula Oxygen Supplementation in Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal&#xD;
      oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under&#xD;
      moderate sedation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Number of Participants With Oxygen Saturations Below 92%</measure>
    <time_frame>During surgical procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Needed Airway Assistance Interventions</measure>
    <time_frame>During surgical procedure</time_frame>
    <description>(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Oxygen Administration During Deep Sedation</condition>
  <arm_group>
    <arm_group_label>Nasopharyngeal catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal Cannula</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasopharyngeal catheter</intervention_name>
    <arm_group_label>Nasopharyngeal catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal Cannula</intervention_name>
    <arm_group_label>Nasal Cannula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oxygen Supplementation</intervention_name>
    <description>Initially set at 3 liters/minute</description>
    <arm_group_label>Nasal Cannula</arm_group_label>
    <arm_group_label>Nasopharyngeal catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sedation</intervention_name>
    <description>Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist.</description>
    <arm_group_label>Nasal Cannula</arm_group_label>
    <arm_group_label>Nasopharyngeal catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients greater than 16 years of age&#xD;
&#xD;
          -  Patients who present for oral surgery or esophagoduodenography and colonoscopy&#xD;
&#xD;
          -  Patients who undergo intravenous sedation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who require endotracheal intubation&#xD;
&#xD;
          -  ASA class 4 or higher&#xD;
&#xD;
          -  Existing esophageal disease such as a perforation or varices&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bret Alvis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <results_first_submitted>February 3, 2017</results_first_submitted>
  <results_first_submitted_qc>May 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2017</results_first_posted>
  <last_update_submitted>May 26, 2017</last_update_submitted>
  <last_update_submitted_qc>May 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Bret Alvis</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>nasopharyngeal catheter</keyword>
  <keyword>nasal cannula</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nasopharyngeal Catheter</title>
          <description>Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasopharyngeal catheter&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
        </group>
        <group group_id="P2">
          <title>Nasal Cannula</title>
          <description>Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasal Cannula&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>case cancelled</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>catheter malfunction</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nasopharyngeal Catheter</title>
          <description>Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasopharyngeal catheter&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
        </group>
        <group group_id="B2">
          <title>Nasal Cannula</title>
          <description>Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasal Cannula&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</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="27"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Oxygen Saturations Below 92%</title>
        <time_frame>During surgical procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nasopharyngeal Catheter</title>
            <description>Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasopharyngeal catheter&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
          </group>
          <group group_id="O2">
            <title>Nasal Cannula</title>
            <description>Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasal Cannula&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Oxygen Saturations Below 92%</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Needed Airway Assistance Interventions</title>
        <description>(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).</description>
        <time_frame>During surgical procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nasopharyngeal Catheter</title>
            <description>Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasopharyngeal catheter&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
          </group>
          <group group_id="O2">
            <title>Nasal Cannula</title>
            <description>Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasal Cannula&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Needed Airway Assistance Interventions</title>
          <description>(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitoring for the entire procedure all the way through the patients discharge from the post-anesthesia care unit. This would average around 4 hours of time; however, no time limit was placed on our adverse event monitoring. Once the procedure started to the point they were taken to their form of transportation, each subject was monitored for an adverse event.</time_frame>
      <desc>The data collection individual would report to the primary investigator and submit report to the Vanderbilt University Institution Review Board.</desc>
      <group_list>
        <group group_id="E1">
          <title>Nasopharyngeal Catheter</title>
          <description>Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasopharyngeal catheter&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
        </group>
        <group group_id="E2">
          <title>Nasal Cannula</title>
          <description>Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.&#xD;
Nasal Cannula&#xD;
Oxygen Supplementation: Initially set at 4 liters/minute&#xD;
Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Other</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Nose Bleed</sub_title>
                <description>Nose Bleed from NasoPharyngeal Catheter Placement</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Cindy Pastern, RN BSN CCRP</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>615-343-0259</phone>
      <email>cindy.pastern@vanderbilt.edu</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/NCT02219464
org study id: 130627
nct id: NCT02219464
lead sponsor: 
has dmc: Yes
The investigators plan to conduct a randomized, controlled trial comparing nasopharyngeal
      oxygen supplementation to traditional nasal cannula in patients undergoing oral surgery under
      moderate sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Oxygen Saturations Below 92%
time frame: During surgical procedure
measure: Number of Participants Who Needed Airway Assistance Interventions
time frame: During surgical procedure
description: (jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).
arm group label: Nasopharyngeal catheter
arm group type: Active Comparator
description: Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.
arm group label: Nasal Cannula
arm group type: Other
description: Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.
intervention type: Device
intervention name: Nasopharyngeal catheter
arm group label: Nasopharyngeal catheter
intervention type: Device
intervention name: Nasal Cannula
arm group label: Nasal Cannula
intervention type: Procedure
intervention name: Oxygen Supplementation
description: Initially set at 3 liters/minute
arm group label: Nasal Cannula
arm group label: Nasopharyngeal catheter
intervention type: Procedure
intervention name: Sedation
description: Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist.
arm group label: Nasal Cannula
arm group label: Nasopharyngeal catheter
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Bret Alvis, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Bret Alvis
investigator title: Assistant Professor
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