<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/NCT03840876</url>
  </required_header>
  <id_info>
    <org_study_id>WNJ</org_study_id>
    <nct_id>NCT03840876</nct_id>
  </id_info>
  <brief_title>SJOV With WNJ in Microlaryngeal Surgery</brief_title>
  <acronym>WNJ</acronym>
  <official_title>Supraglottic Jet Oxygenation and Ventilation Via Nasal Approach During Laser Microlaryngeal Surgery for Vocal Polyps Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye &amp; ENT Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eye &amp; ENT Hospital of Fudan University</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 key to a successful microlaryngoscopy is adequate operative field exposure and&#xD;
      illumination. A variety of airway control procedures has been developed to improve operative&#xD;
      exposure. A small size endotracheal tube is commonly used. However, some surgeon may suggest&#xD;
      a 'no-tube' technique to optimize the surgical field. This study aims to investigate&#xD;
      effectiveness and safety of a novel technique by supraglottic jet oxygenation and ventilation&#xD;
      (SJOV) via nasal approach to facilitate optimal visualization in laser microlaryngeal surgery&#xD;
      for small vocal polyps resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The allocation sequence is generated by computer random number generation, and the allocation&#xD;
      is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment&#xD;
      and data collection are performed by trained research staff who are not involved in the care&#xD;
      of the patients. The treating clinicians are not possible to be blinded to the assignment&#xD;
      group, but all other staff involved in both the collection and collation of data, and&#xD;
      administration of neurocognitive testing, are blinded to group allocation.&#xD;
&#xD;
      The primary measurement is numerical rating scale (NRS) rated by surgeon according to&#xD;
      surgical exposure and visualization. The secondary measurements are operation duration, and&#xD;
      Intraoperative pulse oximetry (SpO2), PetCO2.&#xD;
&#xD;
      The continuous variables were expressed as means ± standard deviation (SD) whereas&#xD;
      categorical variables were expressed as frequency and percentage for data description.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical rating scale (NRS) rated by surgeon</measure>
    <time_frame>Immediately after surgery, the surgeons rated surgical exposure and visualization with NRS only once.</time_frame>
    <description>The surgeons rated surgical exposure and visualization on a numerical rating scale (NRS), ranging from 0 to 10, with 0 defined as the best condition and 10 as the worst.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operation duration</measure>
    <time_frame>Immediately after surgery, the duration of the operation was recorded by the investigator.</time_frame>
    <description>Duration of the operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Other Complications of Surgical and Medical Procedures</condition>
  <arm_group>
    <arm_group_label>Group J</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jet ventilation was achieved via supraglottic jet oxygenation and ventilation with WEI NASAL JET (WNJ).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients were ventilated with a small size endotracheal tube.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WEI NASAL JET (WNJ)</intervention_name>
    <description>Jet ventilation was achieved with WEI NASAL JET (WNJ) connected to a manual jet ventilator (Driving pressure: 40 psi, fraction of inspired oxygen: 100% O2, Respiratory rate: 25/min, I/E ratio: 40%)</description>
    <arm_group_label>Group J</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for laser laryngeal surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cardiac, pulmonary, hepatic, or renal dysfunction. Patients with nasal&#xD;
             disease. Patients with anticipated difficult airway.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenxian Li, M.D. Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Eye and ENT Hospital of Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hui Qiao, M.D. Ph.D.</last_name>
    <phone>8615900598163</phone>
    <email>theyellow@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eye, Ear, Nose and Throat Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200031</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Qiao, Doctor</last_name>
      <phone>021-64377134</phone>
      <email>qiaohui@eentanesthesia.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eye &amp; ENT Hospital of Fudan University</investigator_affiliation>
    <investigator_full_name>Hui Qiao</investigator_full_name>
    <investigator_title>Attending Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Jet Ventilation</keyword>
  <keyword>Supraglottic</keyword>
  <keyword>Intranasal</keyword>
  <keyword>Microlaryngeal Surgery</keyword>
  <!-- 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/NCT03840876
org study id: WNJ
nct id: NCT03840876
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The key to a successful microlaryngoscopy is adequate operative field exposure and
      illumination. A variety of airway control procedures has been developed to improve operative
      exposure. A small size endotracheal tube is commonly used. However, some surgeon may suggest
      a 'no-tube' technique to optimize the surgical field. This study aims to investigate
      effectiveness and safety of a novel technique by supraglottic jet oxygenation and ventilation
      (SJOV) via nasal approach to facilitate optimal visualization in laser microlaryngeal surgery
      for small vocal polyps resection.
The allocation sequence is generated by computer random number generation, and the allocation
      is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment
      and data collection are performed by trained research staff who are not involved in the care
      of the patients. The treating clinicians are not possible to be blinded to the assignment
      group, but all other staff involved in both the collection and collation of data, and
      administration of neurocognitive testing, are blinded to group allocation.

      The primary measurement is numerical rating scale (NRS) rated by surgeon according to
      surgical exposure and visualization. The secondary measurements are operation duration, and
      Intraoperative pulse oximetry (SpO2), PetCO2.

      The continuous variables were expressed as means ± standard deviation (SD) whereas
      categorical variables were expressed as frequency and percentage for data description.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Numerical rating scale (NRS) rated by surgeon
time frame: Immediately after surgery, the surgeons rated surgical exposure and visualization with NRS only once.
description: The surgeons rated surgical exposure and visualization on a numerical rating scale (NRS), ranging from 0 to 10, with 0 defined as the best condition and 10 as the worst.
measure: Operation duration
time frame: Immediately after surgery, the duration of the operation was recorded by the investigator.
description: Duration of the operation
arm group label: Group J
arm group type: Experimental
description: Jet ventilation was achieved via supraglottic jet oxygenation and ventilation with WEI NASAL JET (WNJ).
arm group label: Group I
arm group type: No Intervention
description: Patients were ventilated with a small size endotracheal tube.
intervention type: Device
intervention name: WEI NASAL JET (WNJ)
description: Jet ventilation was achieved with WEI NASAL JET (WNJ) connected to a manual jet ventilator (Driving pressure: 40 psi, fraction of inspired oxygen: 100% O2, Respiratory rate: 25/min, I/E ratio: 40%)
arm group label: Group J
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Wenxian Li, M.D. Ph.D.
role: Study Director
affiliation: Eye and ENT Hospital of Fudan University
last name: Hui Qiao, M.D. Ph.D.
phone: 8615900598163
email: theyellow@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Eye & ENT Hospital of Fudan University
investigator full name: Hui Qiao
investigator title: Attending Anesthesiologist