<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/NCT04501692</url>
  </required_header>
  <id_info>
    <org_study_id>VivaOP</org_study_id>
    <nct_id>NCT04501692</nct_id>
  </id_info>
  <brief_title>VivaSight-SL Versus Videolaryngoscopy in Expected Difficult Airway</brief_title>
  <acronym>VivaOP</acronym>
  <official_title>Endotracheal Tube-mounted Camera Assisted Intubation Versus Videolaryngoscopic Intubation in Patients With Expected Difficult Airway - a Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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>
      Patients requiring endotracheal intubation for elective surgery with an expected difficult&#xD;
      airway are randomized to be intubated either by a) videolaryngoscopy or b) an endotracheal&#xD;
      tube-mounted camera.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endotracheal intubation is required for different surgical procedures for mechanical&#xD;
      ventilation and to prevent aspiration of secretions. Endotracheal intubation is usually&#xD;
      performed by direct laryngoscopy (DL), but this technique may fail in patients with a&#xD;
      difficult airway, i.e. during otorhinolaryngologic or oral and maxillofacial surgery. Besides&#xD;
      fiberoptic intubation that is regarded as gold standard, videolaryngoscopy (VL) has evolved&#xD;
      as a valuable alternative technique in patients with a difficult airway. However, VL has its&#xD;
      limitations and may also fail due to insufficient visualization of the larynx. An&#xD;
      endotracheal tube with an integrated camera (VST, VivaSight-SL, Ambu A/S, Ballerup, Denmark)&#xD;
      may allow for direct guidance of the tube and may aid in endotracheal intubation in difficult&#xD;
      airway patients. This tube has been evaluated in intensive care patients and in patients with&#xD;
      morbid adiposity compared to DL, but there is a paucity of data in difficult airway patients,&#xD;
      so far.&#xD;
&#xD;
      Therefore, we aim to test the VST in difficult airway patients compared to VL in a&#xD;
      prospective randomized non-inferiority trial.&#xD;
&#xD;
      Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the&#xD;
      University Medical Center Hamburg-Eppendorf prior to elective surgery.&#xD;
&#xD;
      All patients receive a structured preoperative airway assessment in accordance with standard&#xD;
      operating procedure of the Department of Anesthesiology, University Medical Center&#xD;
      Hamburg-Eppendorf using the implemented in-house algorithm for the prediction of difficult&#xD;
      airway management and the Simplified Airway Risk Index (SARI).&#xD;
&#xD;
      Patients randomized to the intervention group will be intubated with a VST. Depending on&#xD;
      gender and patient's size, tubes with inner diameters of 7.0, 7.5, and 8.0 are available. The&#xD;
      tubes camera is connected to an Ambu aView monitor (Ambu A/S, Ballerup, Denmark). Patients&#xD;
      randomized to the control group are intubated with a C-MAC videolaryngoscope (Karl Storz SE &amp;&#xD;
      Co. KG, Tuttlingen, Germany) with a Macintosh type blade size 3 or 4 blade.&#xD;
&#xD;
      Anesthesia management, the choice of the blade and tube size, as well as the use of adjuncts&#xD;
      like stylets, introducers or forceps or airway optimization maneuvers (e.g. backward upward&#xD;
      rightward pressure [BURP] and optimum external laryngeal manipulation [OELM]) will be left to&#xD;
      the discretion of the attending physician.&#xD;
&#xD;
      All intubations are recorded through the monitors for later review (e.g. Cormack-Lehane and&#xD;
      POGO-score).&#xD;
&#xD;
      Based on an expected endtidal fraction of oxygen after intubation of 80% with a standard&#xD;
      deviation of 8%, and a noninferiority margin of 10%, 2x 24 patients are required with errors&#xD;
      of α=0.025 and β=0.2 (PASS version 08.0.6, NCSS, LLC. Kaysville, UT, USA).&#xD;
&#xD;
      All participating physicians are anesthesiology residents or fellows. To avoid a bias that&#xD;
      may occur due to different skills for VL compared to the VST, physicians participating in&#xD;
      this study take part in a structured manikin airway training. The age and months of work&#xD;
      experience of the participating anesthetists will be assessed within a questionnaire. It has&#xD;
      been shown that novice physicians are able to reliably intubate a manikin with the VST after&#xD;
      a 30 min training session of DL and VST. For VL, it has been shown that novice physicians may&#xD;
      intubate manikins set up to a difficult airway scenario after a brief introduction and five&#xD;
      intubations with the VL and that anesthesiology residents may quickly adopt the use of the&#xD;
      C-MAC VL.&#xD;
&#xD;
      Therefore, participating physicians are trained for 30 min under the supervision of an&#xD;
      independent anesthetist before participating in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Actual">February 12, 2021</completion_date>
  <primary_completion_date type="Actual">February 12, 2021</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>
    <intervention_model_description>randomized 1:1</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>device for intubation may not be blinded for provider or investigator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>first-pass success</measure>
    <time_frame>15 minutes</time_frame>
    <description>percentage of successful intubations with one attempt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>end-tidal oxygen fraction</measure>
    <time_frame>15 minutes</time_frame>
    <description>the lowest end-tidal oxygen fraction within two minutes after successful intubation after a standardized preoxygenation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall success rate</measure>
    <time_frame>15 minutes</time_frame>
    <description>percentage of successful intubations with the allocated procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to successful intubation</measure>
    <time_frame>15 minutes</time_frame>
    <description>time until an endotracheal airway access is established</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to successful intubation with one attempt</measure>
    <time_frame>15 minutes</time_frame>
    <description>time until an endotracheal airway access is established in patients that are intubated at first attempt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intubation difficulty</measure>
    <time_frame>15 minutes</time_frame>
    <description>subjective rating on a visual analogue scale of the difficulty of airway management and questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>end-tidal carbondioxide fraction</measure>
    <time_frame>15 minutes</time_frame>
    <description>the highest end-tidal carbondioxide fraction within two minutes after successful intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of attempts</measure>
    <time_frame>15 minutes</time_frame>
    <description>total number of attempts until airway established</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>aspiration</measure>
    <time_frame>15 minutes</time_frame>
    <description>percentage of patients that vomit and aspirate during intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>esophageal intubation</measure>
    <time_frame>15 minutes</time_frame>
    <description>percentage of accidental esophageal intubation attempts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hypoxia</measure>
    <time_frame>15 minutes</time_frame>
    <description>percentage of patients with a desaturation below a pulsoximetric saturation of 80%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hypotension</measure>
    <time_frame>15 minutes</time_frame>
    <description>percentage of patients with a systolic blood pressure below 70 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intubating conditions</measure>
    <time_frame>15 minutes</time_frame>
    <description>grades according to Cormack-Lehane and POGO</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Airway Management</condition>
  <arm_group>
    <arm_group_label>VivaSight</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intubated with a VivaSight-SL endotracheal tube.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intubated by videolaryngoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VivaSight</intervention_name>
    <description>see above</description>
    <arm_group_label>VivaSight</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Videolaryngoscopy</intervention_name>
    <description>see above</description>
    <arm_group_label>Conventional</arm_group_label>
    <other_name>comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients requiring general anesthesia with transoral tracheal intubation for elective&#xD;
             surgery&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Preoperative airway assessment reveals an expected difficult airway (rated by the&#xD;
             responsible anesthetist in the Pre-assessment Clinic based on the existing in-house&#xD;
             algorithm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Confirmed indications for awake fiberoptic intubation especially due to enoral,&#xD;
             pharyngeal tumors, abscesses or other processes&#xD;
&#xD;
          -  Planned endotracheal intubation without deep anesthesia or neuromuscular blocking&#xD;
             agents (e.g. awake videolaryngoscopy)&#xD;
&#xD;
          -  Required transnasal tracheal intubation (e.g. for surgical reasons)&#xD;
&#xD;
          -  Requirement of special endotracheal tubes such as laser or RAE tubes for surgical&#xD;
             reasons&#xD;
&#xD;
          -  Patients at risk for pulmonary aspiration who qualify for rapid sequence induction&#xD;
&#xD;
          -  Loose teeth&#xD;
&#xD;
          -  Denial of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joern Grensemann, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Petzoldt, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <state>HH</state>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</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/NCT04501692
org study id: VivaOP
nct id: NCT04501692
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients requiring endotracheal intubation for elective surgery with an expected difficult
      airway are randomized to be intubated either by a) videolaryngoscopy or b) an endotracheal
      tube-mounted camera.
Endotracheal intubation is required for different surgical procedures for mechanical
      ventilation and to prevent aspiration of secretions. Endotracheal intubation is usually
      performed by direct laryngoscopy (DL), but this technique may fail in patients with a
      difficult airway, i.e. during otorhinolaryngologic or oral and maxillofacial surgery. Besides
      fiberoptic intubation that is regarded as gold standard, videolaryngoscopy (VL) has evolved
      as a valuable alternative technique in patients with a difficult airway. However, VL has its
      limitations and may also fail due to insufficient visualization of the larynx. An
      endotracheal tube with an integrated camera (VST, VivaSight-SL, Ambu A/S, Ballerup, Denmark)
      may allow for direct guidance of the tube and may aid in endotracheal intubation in difficult
      airway patients. This tube has been evaluated in intensive care patients and in patients with
      morbid adiposity compared to DL, but there is a paucity of data in difficult airway patients,
      so far.

      Therefore, we aim to test the VST in difficult airway patients compared to VL in a
      prospective randomized non-inferiority trial.

      Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the
      University Medical Center Hamburg-Eppendorf prior to elective surgery.

      All patients receive a structured preoperative airway assessment in accordance with standard
      operating procedure of the Department of Anesthesiology, University Medical Center
      Hamburg-Eppendorf using the implemented in-house algorithm for the prediction of difficult
      airway management and the Simplified Airway Risk Index (SARI).

      Patients randomized to the intervention group will be intubated with a VST. Depending on
      gender and patient's size, tubes with inner diameters of 7.0, 7.5, and 8.0 are available. The
      tubes camera is connected to an Ambu aView monitor (Ambu A/S, Ballerup, Denmark). Patients
      randomized to the control group are intubated with a C-MAC videolaryngoscope (Karl Storz SE &
      Co. KG, Tuttlingen, Germany) with a Macintosh type blade size 3 or 4 blade.

      Anesthesia management, the choice of the blade and tube size, as well as the use of adjuncts
      like stylets, introducers or forceps or airway optimization maneuvers (e.g. backward upward
      rightward pressure [BURP] and optimum external laryngeal manipulation [OELM]) will be left to
      the discretion of the attending physician.

      All intubations are recorded through the monitors for later review (e.g. Cormack-Lehane and
      POGO-score).

      Based on an expected endtidal fraction of oxygen after intubation of 80% with a standard
      deviation of 8%, and a noninferiority margin of 10%, 2x 24 patients are required with errors
      of α=0.025 and β=0.2 (PASS version 08.0.6, NCSS, LLC. Kaysville, UT, USA).

      All participating physicians are anesthesiology residents or fellows. To avoid a bias that
      may occur due to different skills for VL compared to the VST, physicians participating in
      this study take part in a structured manikin airway training. The age and months of work
      experience of the participating anesthetists will be assessed within a questionnaire. It has
      been shown that novice physicians are able to reliably intubate a manikin with the VST after
      a 30 min training session of DL and VST. For VL, it has been shown that novice physicians may
      intubate manikins set up to a difficult airway scenario after a brief introduction and five
      intubations with the VL and that anesthesiology residents may quickly adopt the use of the
      C-MAC VL.

      Therefore, participating physicians are trained for 30 min under the supervision of an
      independent anesthetist before participating in this study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized 1:1
primary purpose: Treatment
masking: Single (Participant)
masking description: device for intubation may not be blinded for provider or investigator.
measure: first-pass success
time frame: 15 minutes
description: percentage of successful intubations with one attempt
measure: end-tidal oxygen fraction
time frame: 15 minutes
description: the lowest end-tidal oxygen fraction within two minutes after successful intubation after a standardized preoxygenation
measure: overall success rate
time frame: 15 minutes
description: percentage of successful intubations with the allocated procedure
measure: time to successful intubation
time frame: 15 minutes
description: time until an endotracheal airway access is established
measure: time to successful intubation with one attempt
time frame: 15 minutes
description: time until an endotracheal airway access is established in patients that are intubated at first attempt
measure: intubation difficulty
time frame: 15 minutes
description: subjective rating on a visual analogue scale of the difficulty of airway management and questionnaire
measure: end-tidal carbondioxide fraction
time frame: 15 minutes
description: the highest end-tidal carbondioxide fraction within two minutes after successful intubation
measure: number of attempts
time frame: 15 minutes
description: total number of attempts until airway established
measure: aspiration
time frame: 15 minutes
description: percentage of patients that vomit and aspirate during intubation
measure: esophageal intubation
time frame: 15 minutes
description: percentage of accidental esophageal intubation attempts
measure: hypoxia
time frame: 15 minutes
description: percentage of patients with a desaturation below a pulsoximetric saturation of 80%
measure: hypotension
time frame: 15 minutes
description: percentage of patients with a systolic blood pressure below 70 mmHg
measure: intubating conditions
time frame: 15 minutes
description: grades according to Cormack-Lehane and POGO
arm group label: VivaSight
arm group type: Experimental
description: Intubated with a VivaSight-SL endotracheal tube.
arm group label: Conventional
arm group type: Active Comparator
description: Intubated by videolaryngoscopy.
intervention type: Procedure
intervention name: VivaSight
description: see above
arm group label: VivaSight
intervention type: Procedure
intervention name: Videolaryngoscopy
description: see above
arm group label: Conventional
other name: comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joern Grensemann, MD
role: Study Chair
affiliation: Universitätsklinikum Hamburg-Eppendorf
last name: Martin Petzoldt, MD
role: Study Chair
affiliation: Universitätsklinikum Hamburg-Eppendorf
facility: 
country: Germany
responsible party type: Sponsor