<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/NCT01709890</url>
  </required_header>
  <id_info>
    <org_study_id>SZENG1.0</org_study_id>
    <nct_id>NCT01709890</nct_id>
  </id_info>
  <brief_title>Evaluation of a New Airway Device - the YO2(R) Catheter in Patients Under Sedation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <brief_summary>
    <textblock>
      Patients under sedation not uncommonly develop upper airway obstruction or other respiratory&#xD;
      complications and no airway device is available to provide reliable maintenance of the airway&#xD;
      at present. I believe the YO2(R)airway catheter can improve the maintenance of patent airway&#xD;
      in most sedated patients and improve O2 delivery to the airway. In addition it may also&#xD;
      greatly facilitate the monitoring of expired CO2, which is widely recognised as the most&#xD;
      important monitor of adequacy of breathing, yet frequently impossible to perform&#xD;
      satisfactorily in sedated patients at the moment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Patients Undergoing Anesthesiologist-administered iv Sedation During Diagnostic/ Therapeutic Procedures</condition>
  <arm_group>
    <arm_group_label>Airway catheter during sedation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>YO2(R) catheter</intervention_name>
    <arm_group_label>Airway catheter during sedation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic&#xD;
        procedures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patient, age &gt;18 and &lt;80&#xD;
&#xD;
          2. Undergoing anesthesiologist-administered sedation for diagnostic/ therapeutic&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Expected procedure require access to or involve the nostrils.&#xD;
&#xD;
          2. Obesity (BMI &gt;=30)&#xD;
&#xD;
          3. Chronic lung diseases (e.g. COPD) associated with chronic hypoxia&#xD;
&#xD;
          4. Pregnant or lactating women.&#xD;
&#xD;
          5. Known chronic liver or renal disease.&#xD;
&#xD;
          6. Mentally incapable of providing informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM</last_name>
    <phone>+852 22553303</phone>
    <email>jkfng@hku.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anaesthesiology, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <zip>HKSAR</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM</last_name>
      <phone>+852 22553303</phone>
      <email>jkfng@hku.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</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 18, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01709890
org study id: SZENG1.0
nct id: NCT01709890
lead sponsor: 
Patients under sedation not uncommonly develop upper airway obstruction or other respiratory
      complications and no airway device is available to provide reliable maintenance of the airway
      at present. I believe the YO2(R)airway catheter can improve the maintenance of patent airway
      in most sedated patients and improve O2 delivery to the airway. In addition it may also
      greatly facilitate the monitoring of expired CO2, which is widely recognised as the most
      important monitor of adequacy of breathing, yet frequently impossible to perform
      satisfactorily in sedated patients at the moment.
observational model: Cohort
time perspective: Prospective
arm group label: Airway catheter during sedation
intervention type: Device
intervention name: YO2(R) catheter
arm group label: Airway catheter during sedation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM
phone: +852 22553303
email: jkfng@hku.hk
facility: 
contact: 
country: China
responsible party type: Sponsor