<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/NCT04487977</url>
  </required_header>
  <id_info>
    <org_study_id>ISAM-COVID</org_study_id>
    <nct_id>NCT04487977</nct_id>
  </id_info>
  <brief_title>Survey on COVID-19 Airway Management</brief_title>
  <acronym>ISAM-COVID</acronym>
  <official_title>International Survey on Airway Management in COVID-19 Patients (ISAM-COVID)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spanish Society of Anesthesia and Critical Care (SEDAR)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Confederation of Latin American Societies of Anaesthesiology (CLASA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spanish Society of Anesthesia and Critical Care (SEDAR)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to analyze the best device for intubation in patients&#xD;
      infected by SARS-CoV2 virus during COVID-19 pandemics and to review the optimal methods for&#xD;
      airway management in such patients for elective surgery and in the Critical Care environment.&#xD;
      Also, the safest methods for airway management in thoracic surgery will be analyzed.&#xD;
&#xD;
      This study has a descriptive design with no hypothesis contrast, and it will explore the&#xD;
      current picture in airway management in Spain. It is a multicentric international study, for&#xD;
      all the centers where intubations of tracheostomies have been performed in patients diagnosed&#xD;
      with SARS-CoV2 with positive PCR, either in the Critical Care setting or the operating room.&#xD;
&#xD;
      A survey will be distributed among professionals who have been involved in airway management&#xD;
      in COVID-19 patients in the following specialties: Anesthesiology and Critical Care Medicine,&#xD;
      Emergency Medicine, Prehospital Medicine, Cardiology and Pulmonology.&#xD;
&#xD;
      The study started on april 2020 after receiving approval from the Ethics Committee (General&#xD;
      University Hospital of Valencia) COVID-19 infection causes respiratory failure needing&#xD;
      ventilatory support, which required endotracheal intubation or tracheostomy. This situation&#xD;
      poses a significant risk of transmission due to its usual urgent nature, and it often happens&#xD;
      in the context of respiratory claudication. For this reason, studying the safest and useful&#xD;
      methods for airway management in this kind of patients, using data based on the clinical&#xD;
      experience, may be of great interest in the future.&#xD;
&#xD;
      Statistical analysis will be performed using Statistical Software R, . Technical&#xD;
      characteristics will be described using frequencies and percentages for categorical&#xD;
      variables, and means and standard deviations or medians and interquartile ranges for&#xD;
      continuous variables, depending on normality tests. Base characteristics, center and years of&#xD;
      experience will be compared.&#xD;
&#xD;
      A sample size calculation is not necessary, since it is an explorative and voluntary study,&#xD;
      trying to establish which are the regular routines in airway management in COVID-19 patients&#xD;
      in Spain and Latin America.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Justification There are no studies about safety and effectiveness of different airway&#xD;
           management procedures in COVID-19 patients in Spain or Latin America.&#xD;
&#xD;
           Due to the emergent nature of this disease, there are very few solid and universal&#xD;
           publications about safety or validated protocols in SARS-CoV-2 disease airway&#xD;
           management.&#xD;
&#xD;
           In the last months, and following the clinical experience coming from China and Italy,&#xD;
           we have been able to see how SARS-CoV-2 virus has caused severe morbidity or death in&#xD;
           thousands of patients. In this line, and considering the high transmission rate of this&#xD;
           disease, we observe how professionals from these countries have performed airway&#xD;
           management to provide proper ventilation and oxygenation, in either potentially&#xD;
           critically ill patients or in a surgical context. Their experience has allowed other&#xD;
           countries to develop specific protocols, and to quickly adapt them to the updates that&#xD;
           keep happening daily.&#xD;
&#xD;
           For this reason, we want to explore the Spanish and Latin American experience in airway&#xD;
           management. It is important to draw conclusions not only from the preparations and&#xD;
           technical approaches, but also the information stemming from the context in which the&#xD;
           procedure is performed, the stress derived from the risk of transmission and the&#xD;
           personal protective equipment, as well as the particular difficulties they add to the&#xD;
           technique.&#xD;
&#xD;
        2. Hypothesis: Since it is a descriptive study, there is no formal hypothesis in this work.&#xD;
&#xD;
           Objectives&#xD;
&#xD;
        3. Objectives:&#xD;
&#xD;
           3.1. Main objective: To analyze the preferred device for intubation in patients infected&#xD;
           by SARS-CoV2 virus during COVID-19 pandemics using a survey addressed to health care&#xD;
           professionals experienced in assistance to COVID-19 patients. The preferred device will&#xD;
           be rated using an ordinal scoring scale and it will be presented as the device with the&#xD;
           highest score.&#xD;
&#xD;
           3.2. Secondary objectives: To assess the preferred methods for airway management in&#xD;
           COVID-19 patients in a Critical Care setting or undergoing urgent or elective surgery.&#xD;
&#xD;
        4. Design: Descriptive design with no hypothesis contrast, exploring the current panorama&#xD;
           in airway management in Spain and Latin America.&#xD;
&#xD;
        5. Ambit: Multicenter and international for Spain and Latin America, for all the health&#xD;
           care centers where intubations or tracheostomies have been performed in COVID-19&#xD;
           patients with a positive PCR, either in the Critical Care setting or in the operating&#xD;
           room.&#xD;
&#xD;
        6. Study population: The study population will consist of all the health care professionals&#xD;
           who have been or are currently involved in airway management in COVID-19 positive&#xD;
           patients, from the following medical specialties: Anesthesiology and Critical Care&#xD;
           Medicine, Emergency Medicine, Pre-Hospital Medicine, Cardiology, Pulmonology.&#xD;
&#xD;
        7. Variables:&#xD;
&#xD;
           7.1. Main variable: Optimal device: Which is the best rated device for endotracheal&#xD;
           intubation in COVID-19 patients.&#xD;
&#xD;
           7.2. Secondary variables:&#xD;
&#xD;
             -  Context in which the professional has experience when intubation COVID-19 patient:&#xD;
                1. Critical Context (Emergency Department, Critical Care Unit), 2. Emergent&#xD;
                Surgery, 3. Elective Surgery.&#xD;
&#xD;
             -  Professional opinion about the usefulness of different systems for reducing aerosol&#xD;
                production or diffusion (from 1 to 6, where 1 is the least useful and 6 is the most&#xD;
                useful): 1. Methacrylate box with accesses for the arms, 2. Face mask tight seal,&#xD;
                3. Negative pressure system in the intubation area, 4. Avoidance of hand&#xD;
                ventilation, 5. Rapid sequence intubation, 6. Sellick maneuver, 7. Other.&#xD;
&#xD;
             -  Professional opinion about the importance of the different drawbacks of video&#xD;
                laryngoscopes (from 1 to 6, where 1 is the most important and 6 is the least&#xD;
                important): 1. Reflections on the screen, 2. Difficulty to introduce the blade in&#xD;
                the mouth, 3. Proximity to the patient's airway, 4. Difficulty to insert the tube&#xD;
                through the vocal cords, 5. Lack of experience with the specific video laryngoscope&#xD;
                used, 6. Preference for direct laryngoscopy due to higher experience and confidence&#xD;
                with it.&#xD;
&#xD;
             -  Type of blade most often used by use: 1. Reusable, 2. Disposable.&#xD;
&#xD;
             -  Type of blade most often used by channel: 1. With channel, 2. Without channel.&#xD;
&#xD;
             -  Type of blade most often used by curvature: 1. Regular curve, 2. Hyper Curved.&#xD;
&#xD;
             -  Type of video laryngoscope screen: 1. Integrated with the main device, 2. Away from&#xD;
                the device.&#xD;
&#xD;
             -  Type of aid device (from 1 to 6, where 1 is the least useful and 6 is the most&#xD;
                useful): 1. Frova introducer, 2. Eschman introducer, 3. Flexible introducer inside&#xD;
                the tube, 4. Flexible endoscope, 5. VAMA, 6. Other.&#xD;
&#xD;
             -  Preferred method for intubation in the foreseen difficult airway situation (from 1&#xD;
                to 6, where 1 is the most preferred and 6 is the least preferred): 1. Fiberoptic&#xD;
                intubation, 2. Intubation with video laryngoscope, 3. Direct laryngoscopy, 4. McCoy&#xD;
                laryngoscope, 5. Intubation through a laryngeal mask, 6. Tracheostomy.&#xD;
&#xD;
             -  Preferred method for intubation in the unforeseen difficult airway situation (from&#xD;
                1 to 6, where 1 is the least preferred and 6 is the most preferred):1. Fiberoptic&#xD;
                intubation, 2. Intubation with video laryngoscope, 3. Direct laryngoscopy, 4. McCoy&#xD;
                laryngoscope, 5. Intubation through a laryngeal mask, 6. Tracheostomy.&#xD;
&#xD;
             -  Preferred strategies upon surgical conclusion in COVID-19 patients (from 1 to 6,&#xD;
                where 1 is the least preferred and 6 is the most preferred): 1. To extubate all&#xD;
                patients in the Critical Care Unit, 2. To extubate all patients in the operating&#xD;
                room, 3. To extubate only stable patients in the operating room, if postoperative&#xD;
                ventilation os not expected, 4. Other.&#xD;
&#xD;
             -  Preferred procedures in intubated COVID-19 patients who need a tracheostomy (from 1&#xD;
                to 6, where 1 is the least preferred and 6 is the most preferred): 1. Open&#xD;
                conventional tracheostomy, 2. Percutaneous tracheostomy, 3. Fiberoptic guidance to&#xD;
                conduct location and opening of the trachea, 4. Apnea or ventilator stand-by for as&#xD;
                long as possible.&#xD;
&#xD;
             -  Professional rating of different assertions about techniques and equipment to&#xD;
                intubate COVID-19 patients (from 1 to 6, where 1 is the lowest validity and 6 is&#xD;
                the highest validity): 1. It is concerning to use reusable material with the&#xD;
                possibility of contamination, 2. It is concerning to move intubation equipment from&#xD;
                COVID-19 to non-COVID-19 areas, 3. Swiftly intubating critical or severely&#xD;
                deteriorated COVID-19 patients is related to a higher risk of transmission, 4.&#xD;
                Airway management maneuvers with personal protective equipment are more difficult&#xD;
                and uncomfortable.&#xD;
&#xD;
           Specific variables in the thoracic surgery context, to be answered only by professionals&#xD;
           working with such patients:&#xD;
&#xD;
             -  Experience in thoracic anesthesia: 1. Over 10 years, 2. From 5 to 10 years, 3.&#xD;
                Under 5 years, 4. No experience.&#xD;
&#xD;
             -  Preferred method to perform lung isolation in COVID-19 patients (from 1 to 6, where&#xD;
                1 is the least preferred and 6 is the most preferred): 1. Conventional double lumen&#xD;
                tubes and flexible endoscope, 2. Double lumen tubes with attached camera, 3.&#xD;
                Bronchial blocker, endotracheal tube and flexible endoscope, 4. Bronchial blocker&#xD;
                and endotracheal tube with attached camera (Viva Sight ®), 5. Univent ® tube and&#xD;
                flexible endoscope, 6. Other.&#xD;
&#xD;
             -  Preferred video laryngoscope for double lumen tube insertion in COVID-19 patients&#xD;
                with a difficult airway (from 1 to 6, where 1 is the least preferred and 6 is the&#xD;
                most preferred): 1. C-MAC ®, 2. King Vision ®, 3. McGrath ®, 3. GlideScope ®, 4.&#xD;
                Airtraq ®, 5. Other.&#xD;
&#xD;
             -  Preferred bronchial blocker for COVID-19 patients (from 1 to 6, where 1 is the&#xD;
                least preferred and 6 is the most preferred): 1. Arndt, 2. Cohen, 3. Univent ®&#xD;
                tube, 4. EZ Blocker ®, 5. Fogarty catheter, 6. Other)&#xD;
&#xD;
             -  Preferred position for the antiviral /antibacterial filter (from 1 to 6, where 1 is&#xD;
                the least preferred and 6 is the most preferred): 1. Expiratory branch, 2.&#xD;
                Inspiratory branch, 3. Y bifurcation, 4. Proximal end of the endobronchial lumen of&#xD;
                the double lumen tube, leading to the non ventilated lung to be collapsed, 5.&#xD;
                Proximal end of the bronchial blocker, if it is used.&#xD;
&#xD;
             -  Usefulness of the closed and regulable aspiration system for the non ventilated&#xD;
                lung: 1. Yes, 2. No.&#xD;
&#xD;
             -  Preferred strategies upon surgical conclusion in COVID-19 patients (from 1 to 6,&#xD;
                where 1 is the least preferred and 6 is the most preferred): 1. To extubate all&#xD;
                patients in the Critical Care Unit, 2. To extubate all patients in the operating&#xD;
                room, 3. To extubate only stable patients in the operating room, if postoperative&#xD;
                ventilation os not expected, 4. To exchange the double lumen tube for an&#xD;
                endotracheal tube and extubation in the post anesthesia unit, 5. To withdraw the&#xD;
                double lumen tube to the trachea for subsequent extubation in the post anesthesia&#xD;
                unit, 6. To remove the bronchial blocker and leave the endotracheal tube for&#xD;
                subsequent extubation in the post anesthesia unit, 7. To remove the bronchial&#xD;
                blocker from the Univent ® tube and subsequent extubation in the post anesthesia&#xD;
                unit, 8. Other.&#xD;
&#xD;
             -  Number of intubations performed in COVID-19 patients.&#xD;
&#xD;
             -  Personal SARS-CoV-2 infection: 1. Yes, 2. No.&#xD;
&#xD;
        8. Information sources: Variables will be obtained from a voluntary survey accessible from&#xD;
           the Internet, created with Microsoft Forms ®. Microsoft Forms ® is a digital platform&#xD;
           with a free access plan which allows quick and development of digital surveys with no&#xD;
           need for programming. It also includes a set of tools to distribute and gather the&#xD;
           results from the questionnaires. The survey is accessed from a link sent via e-mail or&#xD;
           other digital distribution methods to the potential participants.&#xD;
&#xD;
        9. Interventions and procedures: There is no need for interventions on patients or their&#xD;
           clinical records. A single intervention will take place on the participants in the&#xD;
           moment of sending the survey. This only contact will provide all the aforementioned&#xD;
           variables.&#xD;
&#xD;
       10. Sample size calculation: There is no need for sample size calculation, since the study&#xD;
           is explorative and voluntary, trying to assess clinical routines in airway management.&#xD;
&#xD;
       11. Statistical plan: Statistical analysis will be performed using Statistical Software R, .&#xD;
           Technical characteristics will be described using frequencies and percentages for&#xD;
           categorical variables, and means and standard deviations or medians and interquartile&#xD;
           ranges for continuous variables, depending on normality tests. Base characteristics,&#xD;
           center and years of experience will be compared. Proper figures will be presented to&#xD;
           represent the results about which are the most used techniques and devices, as well as&#xD;
           the most important features of every procedure.&#xD;
&#xD;
       12. Ethical considerations:&#xD;
&#xD;
      12.1. General considerations: The study is to be conducted according to this protocol,&#xD;
      Helsinki Ethical Principles Declaration and currently existing directives.&#xD;
&#xD;
      12.2. Informed consent: An informed consent form is not necessary, since the survey will be&#xD;
      completed by professionals who provided care to the patients in a retrospective manner, with&#xD;
      no diagnostic or therapeutic interventions. Besides, since it is a retrospective study with&#xD;
      anonymous data, there is no possibility to ask for an informed consent to the patients. For&#xD;
      these reasons, an exemption for informed consent was requested and accepted by the Ethics&#xD;
      Committee.&#xD;
&#xD;
      12.3. Data protection: Data from the participants will be managed according to existing&#xD;
      spanish and european laws (Spanish Law 3/2018 on Personal Data Protection and Digital Rights&#xD;
      Warranty, and EU Regulation UE 2016/679). Gathered data for the study will be identified with&#xD;
      a code, and the information will not include identificatory details of the participants, thus&#xD;
      not being able to reveal their identities. Names of patients will not be collected or&#xD;
      presented in any publication or communication of the study results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 22, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Preferred device</measure>
    <time_frame>During COVID-19 pandemics in each country, since the release of the survey until its closure, approximately 4 months</time_frame>
    <description>Preferred device for intubation in COVID-19 patients infected by SARS-CoV2</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Airway Management</condition>
  <arm_group>
    <arm_group_label>Surveyed professionals</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>Answering a survey on airway management in COVID-19 patients</description>
    <arm_group_label>Surveyed professionals</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Professionals belonging to medical specialties involved in airway management who have&#xD;
        performed intubation and/or tracheostomy maneuvers in COVID-19 patients during current&#xD;
        pandemics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Professionals belonging to medical specialties involved in airway&#xD;
        management who have performed intubation and/or tracheostomy maneuvers in COVID-19 patients&#xD;
        during current pandemics.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Professionals not belonging to medical specialties involved in airway management or&#xD;
             with no experience in intubation/tracheostomy maneuvers.&#xD;
&#xD;
          -  Those not willing to answer the survey.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Manuel Granell Gil, PhD</last_name>
    <phone>+34609232031</phone>
    <email>mgranellg@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Manuel Granell Gil</last_name>
    <email>cov-viaerea@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Consorcio Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46022</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manuel Granell Gil, Dr</last_name>
      <phone>+34609232031</phone>
      <email>mgranellg@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spanish Society of Anesthesia and Critical Care (SEDAR)</investigator_affiliation>
    <investigator_full_name>Dr. Manuel Granell Gil</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>airway</keyword>
  <keyword>COVID-19</keyword>
  <keyword>critical care</keyword>
  <keyword>anesthesia</keyword>
  <keyword>airway management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04487977
org study id: ISAM-COVID
nct id: NCT04487977
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The objectives of this study are to analyze the best device for intubation in patients
      infected by SARS-CoV2 virus during COVID-19 pandemics and to review the optimal methods for
      airway management in such patients for elective surgery and in the Critical Care environment.
      Also, the safest methods for airway management in thoracic surgery will be analyzed.

      This study has a descriptive design with no hypothesis contrast, and it will explore the
      current picture in airway management in Spain. It is a multicentric international study, for
      all the centers where intubations of tracheostomies have been performed in patients diagnosed
      with SARS-CoV2 with positive PCR, either in the Critical Care setting or the operating room.

      A survey will be distributed among professionals who have been involved in airway management
      in COVID-19 patients in the following specialties: Anesthesiology and Critical Care Medicine,
      Emergency Medicine, Prehospital Medicine, Cardiology and Pulmonology.

      The study started on april 2020 after receiving approval from the Ethics Committee (General
      University Hospital of Valencia) COVID-19 infection causes respiratory failure needing
      ventilatory support, which required endotracheal intubation or tracheostomy. This situation
      poses a significant risk of transmission due to its usual urgent nature, and it often happens
      in the context of respiratory claudication. For this reason, studying the safest and useful
      methods for airway management in this kind of patients, using data based on the clinical
      experience, may be of great interest in the future.

      Statistical analysis will be performed using Statistical Software R, . Technical
      characteristics will be described using frequencies and percentages for categorical
      variables, and means and standard deviations or medians and interquartile ranges for
      continuous variables, depending on normality tests. Base characteristics, center and years of
      experience will be compared.

      A sample size calculation is not necessary, since it is an explorative and voluntary study,
      trying to establish which are the regular routines in airway management in COVID-19 patients
      in Spain and Latin America.
1. Justification There are no studies about safety and effectiveness of different airway
           management procedures in COVID-19 patients in Spain or Latin America.

           Due to the emergent nature of this disease, there are very few solid and universal
           publications about safety or validated protocols in SARS-CoV-2 disease airway
           management.

           In the last months, and following the clinical experience coming from China and Italy,
           we have been able to see how SARS-CoV-2 virus has caused severe morbidity or death in
           thousands of patients. In this line, and considering the high transmission rate of this
           disease, we observe how professionals from these countries have performed airway
           management to provide proper ventilation and oxygenation, in either potentially
           critically ill patients or in a surgical context. Their experience has allowed other
           countries to develop specific protocols, and to quickly adapt them to the updates that
           keep happening daily.

           For this reason, we want to explore the Spanish and Latin American experience in airway
           management. It is important to draw conclusions not only from the preparations and
           technical approaches, but also the information stemming from the context in which the
           procedure is performed, the stress derived from the risk of transmission and the
           personal protective equipment, as well as the particular difficulties they add to the
           technique.

        2. Hypothesis: Since it is a descriptive study, there is no formal hypothesis in this work.

           Objectives

        3. Objectives:

           3.1. Main objective: To analyze the preferred device for intubation in patients infected
           by SARS-CoV2 virus during COVID-19 pandemics using a survey addressed to health care
           professionals experienced in assistance to COVID-19 patients. The preferred device will
           be rated using an ordinal scoring scale and it will be presented as the device with the
           highest score.

           3.2. Secondary objectives: To assess the preferred methods for airway management in
           COVID-19 patients in a Critical Care setting or undergoing urgent or elective surgery.

        4. Design: Descriptive design with no hypothesis contrast, exploring the current panorama
           in airway management in Spain and Latin America.

        5. Ambit: Multicenter and international for Spain and Latin America, for all the health
           care centers where intubations or tracheostomies have been performed in COVID-19
           patients with a positive PCR, either in the Critical Care setting or in the operating
           room.

        6. Study population: The study population will consist of all the health care professionals
           who have been or are currently involved in airway management in COVID-19 positive
           patients, from the following medical specialties: Anesthesiology and Critical Care
           Medicine, Emergency Medicine, Pre-Hospital Medicine, Cardiology, Pulmonology.

        7. Variables:

           7.1. Main variable: Optimal device: Which is the best rated device for endotracheal
           intubation in COVID-19 patients.

           7.2. Secondary variables:

             -  Context in which the professional has experience when intubation COVID-19 patient:
                1. Critical Context (Emergency Department, Critical Care Unit), 2. Emergent
                Surgery, 3. Elective Surgery.

             -  Professional opinion about the usefulness of different systems for reducing aerosol
                production or diffusion (from 1 to 6, where 1 is the least useful and 6 is the most
                useful): 1. Methacrylate box with accesses for the arms, 2. Face mask tight seal,
                3. Negative pressure system in the intubation area, 4. Avoidance of hand
                ventilation, 5. Rapid sequence intubation, 6. Sellick maneuver, 7. Other.

             -  Professional opinion about the importance of the different drawbacks of video
                laryngoscopes (from 1 to 6, where 1 is the most important and 6 is the least
                important): 1. Reflections on the screen, 2. Difficulty to introduce the blade in
                the mouth, 3. Proximity to the patient's airway, 4. Difficulty to insert the tube
                through the vocal cords, 5. Lack of experience with the specific video laryngoscope
                used, 6. Preference for direct laryngoscopy due to higher experience and confidence
                with it.

             -  Type of blade most often used by use: 1. Reusable, 2. Disposable.

             -  Type of blade most often used by channel: 1. With channel, 2. Without channel.

             -  Type of blade most often used by curvature: 1. Regular curve, 2. Hyper Curved.

             -  Type of video laryngoscope screen: 1. Integrated with the main device, 2. Away from
                the device.

             -  Type of aid device (from 1 to 6, where 1 is the least useful and 6 is the most
                useful): 1. Frova introducer, 2. Eschman introducer, 3. Flexible introducer inside
                the tube, 4. Flexible endoscope, 5. VAMA, 6. Other.

             -  Preferred method for intubation in the foreseen difficult airway situation (from 1
                to 6, where 1 is the most preferred and 6 is the least preferred): 1. Fiberoptic
                intubation, 2. Intubation with video laryngoscope, 3. Direct laryngoscopy, 4. McCoy
                laryngoscope, 5. Intubation through a laryngeal mask, 6. Tracheostomy.

             -  Preferred method for intubation in the unforeseen difficult airway situation (from
                1 to 6, where 1 is the least preferred and 6 is the most preferred):1. Fiberoptic
                intubation, 2. Intubation with video laryngoscope, 3. Direct laryngoscopy, 4. McCoy
                laryngoscope, 5. Intubation through a laryngeal mask, 6. Tracheostomy.

             -  Preferred strategies upon surgical conclusion in COVID-19 patients (from 1 to 6,
                where 1 is the least preferred and 6 is the most preferred): 1. To extubate all
                patients in the Critical Care Unit, 2. To extubate all patients in the operating
                room, 3. To extubate only stable patients in the operating room, if postoperative
                ventilation os not expected, 4. Other.

             -  Preferred procedures in intubated COVID-19 patients who need a tracheostomy (from 1
                to 6, where 1 is the least preferred and 6 is the most preferred): 1. Open
                conventional tracheostomy, 2. Percutaneous tracheostomy, 3. Fiberoptic guidance to
                conduct location and opening of the trachea, 4. Apnea or ventilator stand-by for as
                long as possible.

             -  Professional rating of different assertions about techniques and equipment to
                intubate COVID-19 patients (from 1 to 6, where 1 is the lowest validity and 6 is
                the highest validity): 1. It is concerning to use reusable material with the
                possibility of contamination, 2. It is concerning to move intubation equipment from
                COVID-19 to non-COVID-19 areas, 3. Swiftly intubating critical or severely
                deteriorated COVID-19 patients is related to a higher risk of transmission, 4.
                Airway management maneuvers with personal protective equipment are more difficult
                and uncomfortable.

           Specific variables in the thoracic surgery context, to be answered only by professionals
           working with such patients:

             -  Experience in thoracic anesthesia: 1. Over 10 years, 2. From 5 to 10 years, 3.
                Under 5 years, 4. No experience.

             -  Preferred method to perform lung isolation in COVID-19 patients (from 1 to 6, where
                1 is the least preferred and 6 is the most preferred): 1. Conventional double lumen
                tubes and flexible endoscope, 2. Double lumen tubes with attached camera, 3.
                Bronchial blocker, endotracheal tube and flexible endoscope, 4. Bronchial blocker
                and endotracheal tube with attached camera (Viva Sight ®), 5. Univent ® tube and
                flexible endoscope, 6. Other.

             -  Preferred video laryngoscope for double lumen tube insertion in COVID-19 patients
                with a difficult airway (from 1 to 6, where 1 is the least preferred and 6 is the
                most preferred): 1. C-MAC ®, 2. King Vision ®, 3. McGrath ®, 3. GlideScope ®, 4.
                Airtraq ®, 5. Other.

             -  Preferred bronchial blocker for COVID-19 patients (from 1 to 6, where 1 is the
                least preferred and 6 is the most preferred): 1. Arndt, 2. Cohen, 3. Univent ®
                tube, 4. EZ Blocker ®, 5. Fogarty catheter, 6. Other)

             -  Preferred position for the antiviral /antibacterial filter (from 1 to 6, where 1 is
                the least preferred and 6 is the most preferred): 1. Expiratory branch, 2.
                Inspiratory branch, 3. Y bifurcation, 4. Proximal end of the endobronchial lumen of
                the double lumen tube, leading to the non ventilated lung to be collapsed, 5.
                Proximal end of the bronchial blocker, if it is used.

             -  Usefulness of the closed and regulable aspiration system for the non ventilated
                lung: 1. Yes, 2. No.

             -  Preferred strategies upon surgical conclusion in COVID-19 patients (from 1 to 6,
                where 1 is the least preferred and 6 is the most preferred): 1. To extubate all
                patients in the Critical Care Unit, 2. To extubate all patients in the operating
                room, 3. To extubate only stable patients in the operating room, if postoperative
                ventilation os not expected, 4. To exchange the double lumen tube for an
                endotracheal tube and extubation in the post anesthesia unit, 5. To withdraw the
                double lumen tube to the trachea for subsequent extubation in the post anesthesia
                unit, 6. To remove the bronchial blocker and leave the endotracheal tube for
                subsequent extubation in the post anesthesia unit, 7. To remove the bronchial
                blocker from the Univent ® tube and subsequent extubation in the post anesthesia
                unit, 8. Other.

             -  Number of intubations performed in COVID-19 patients.

             -  Personal SARS-CoV-2 infection: 1. Yes, 2. No.

        8. Information sources: Variables will be obtained from a voluntary survey accessible from
           the Internet, created with Microsoft Forms ®. Microsoft Forms ® is a digital platform
           with a free access plan which allows quick and development of digital surveys with no
           need for programming. It also includes a set of tools to distribute and gather the
           results from the questionnaires. The survey is accessed from a link sent via e-mail or
           other digital distribution methods to the potential participants.

        9. Interventions and procedures: There is no need for interventions on patients or their
           clinical records. A single intervention will take place on the participants in the
           moment of sending the survey. This only contact will provide all the aforementioned
           variables.

       10. Sample size calculation: There is no need for sample size calculation, since the study
           is explorative and voluntary, trying to assess clinical routines in airway management.

       11. Statistical plan: Statistical analysis will be performed using Statistical Software R, .
           Technical characteristics will be described using frequencies and percentages for
           categorical variables, and means and standard deviations or medians and interquartile
           ranges for continuous variables, depending on normality tests. Base characteristics,
           center and years of experience will be compared. Proper figures will be presented to
           represent the results about which are the most used techniques and devices, as well as
           the most important features of every procedure.

       12. Ethical considerations:

      12.1. General considerations: The study is to be conducted according to this protocol,
      Helsinki Ethical Principles Declaration and currently existing directives.

      12.2. Informed consent: An informed consent form is not necessary, since the survey will be
      completed by professionals who provided care to the patients in a retrospective manner, with
      no diagnostic or therapeutic interventions. Besides, since it is a retrospective study with
      anonymous data, there is no possibility to ask for an informed consent to the patients. For
      these reasons, an exemption for informed consent was requested and accepted by the Ethics
      Committee.

      12.3. Data protection: Data from the participants will be managed according to existing
      spanish and european laws (Spanish Law 3/2018 on Personal Data Protection and Digital Rights
      Warranty, and EU Regulation UE 2016/679). Gathered data for the study will be identified with
      a code, and the information will not include identificatory details of the participants, thus
      not being able to reveal their identities. Names of patients will not be collected or
      presented in any publication or communication of the study results.
observational model: Other
time perspective: Cross-Sectional
measure: Preferred device
time frame: During COVID-19 pandemics in each country, since the release of the survey until its closure, approximately 4 months
description: Preferred device for intubation in COVID-19 patients infected by SARS-CoV2
arm group label: Surveyed professionals
intervention type: Other
intervention name: Survey
description: Answering a survey on airway management in COVID-19 patients
arm group label: Surveyed professionals
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manuel Granell Gil, PhD
phone: +34609232031
email: mgranellg@hotmail.com
last name: Manuel Granell Gil
email: cov-viaerea@hotmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Spanish Society of Anesthesia and Critical Care (SEDAR)
investigator full name: Dr. Manuel Granell Gil
investigator title: Professor
mesh term: COVID-19