xml: <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/NCT05983666</url>
    </required_header>
    <id_info>
      <org_study_id>PATO</org_study_id>
      <nct_id>NCT05983666</nct_id>
    </id_info>
    <brief_title>POCUS ASSESSMENT FOR TRACHEAL VS OESOPHAGEAL INTUBATION</brief_title>
    <acronym>PATO</acronym>
    <official_title>POCUS ASSESSMENT FOR TRACHEAL VS OESOPHAGEAL INTUBATION</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clinica Universidad de Navarra, Universidad de Navarra</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 clinical importance of airway management has gained prominence in the last decade in most&#xD;
        scientific societies with the aim of improving the standard of care.&#xD;
  &#xD;
        The WHO has focused guidelines for &quot;Safety in Surgery&quot;, which attempt to encompass all&#xD;
        methods that predict and recognise airway management risk and should be applied by the&#xD;
        surgical team, and has therefore created and implemented a surgical checklist that can be&#xD;
        useful in reducing the risk of unidentified difficulties.&#xD;
  &#xD;
        The same suggestion has been included in the Helsinki Declaration on Patient Safety in&#xD;
        Anaesthesiology, signed by most European entities in cooperation with the European Society of&#xD;
        Anaesthesiology (ESA), the European Board of Anaesthesiology (EBA-UEMS), and the World&#xD;
        Federation of Societies of Anaesthesiology (WFA).&#xD;
  &#xD;
        Confirmation of correct endotracheal tube (ET) placement is a crucial step in airway&#xD;
        management, as unrecognised oesophageal intubation can have catastrophic consequences.&#xD;
        Numerous methods are used to verify correct ET placement, including visual confirmation of&#xD;
        tube passage through the vocal cords during laryngoscopy, chest wall expansion during&#xD;
        ventilation, visualisation of the tracheal rings and carina using a flexible bronchoscope,&#xD;
        auscultation, capnometry, capnography and chest radiography. These techniques vary in their&#xD;
        degree of precision. Although capnography is considered the gold standard for confirming&#xD;
        tracheal intubation, it has some important limitations.&#xD;
  &#xD;
        In recent years, ultrasonography has been introduced as the fifth pillar of the physical&#xD;
        examination of the patient: inspection, palpation, percussion, auscultation and insonation.&#xD;
        For airway assessment and management, Point-of-Care UltraSound (PoCUS) has been incorporated&#xD;
        into routine clinical practice, answering open diagnostic questions, aiding in differential&#xD;
        diagnosis and guiding procedures.&#xD;
  &#xD;
        Thus, investigators propose a simple, quick and easy-to-learn approach for the interpretation&#xD;
        of ultrasound imaging findings during airway management.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The first step of the algorithm is to locate the oesophagus by asking the patient to swallow.&#xD;
        The ultrasound transducer is placed transversely on the anterior surface of the neck at the&#xD;
        paratracheal level (usually located on the left side), 1-2 cm above the sternal notch or&#xD;
        jugulum. In this image, the trachea is shown as a hyperechoic, curvilinear image (air-mucosa&#xD;
        interface), showing a posterior reverberation artefact called a comet tail. During the&#xD;
        intubation technique, this ultrasound window allows the physician to observe the real-time&#xD;
        passage of the tube into the trachea, confirming correct tracheal intubation only if a single&#xD;
        air-mucosa interface with its comet tail is maintained. This can then be verified by&#xD;
        capnography (if available) or by lung sliding.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Ultrasound Oesophageal Intubation</measure>
      <time_frame>5 minutes</time_frame>
      <description>To assess a diagnostic algorithm for tracheal versus oesophageal intubation using ultrasound and capnography as a confirmatory criterion.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>POCUS learning curve</measure>
      <time_frame>30 minutes</time_frame>
      <description>Time required for the application of the ultrasound algorithm and training time for previously untrained personnel.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Intubation Complication</condition>
    <arm_group>
      <arm_group_label>Patients undergoing scheduled and/or emergency surgery requiring orotracheal intubation.</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ultrasound Oesophageal Intubation</intervention_name>
      <description>Ultrasound Oesophageal intubation detection</description>
      <arm_group_label>Patients undergoing scheduled and/or emergency surgery requiring orotracheal intubation.</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled&#xD;
          and/or emergency surgery requiring orotracheal intubation. Informed consent form must be&#xD;
          signed authorising inclusion in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled&#xD;
          and/or emergency surgery requiring orotracheal intubation. Informed consent form must be&#xD;
          signed authorising inclusion in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          A.- Cervical tumours, goitre or patients who have required cervical radiotherapy.&#xD;
  &#xD;
          B.- Abnormalities leading to alterations of the anatomy such as facial/cervical fractures.&#xD;
  &#xD;
          C.- Those who cannot give their consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Clinica Universidad de Navarra</name>
        <address>
          <city>Madrid</city>
          <zip>28027</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miguel Angel Fernandez-Vaquero, MD,PhD</last_name>
        <phone>0034913531920</phone>
        <phone_ext>7633</phone_ext>
        <email>mfvaquero@unav.es</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Tracheal intubation</keyword>
    <keyword>Ultrasound</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>It is not neccessary to share any data.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983666
  org study id: PATO
  nct id: NCT05983666
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The clinical importance of airway management has gained prominence in the last decade in most
        scientific societies with the aim of improving the standard of care.
  
        The WHO has focused guidelines for "Safety in Surgery", which attempt to encompass all
        methods that predict and recognise airway management risk and should be applied by the
        surgical team, and has therefore created and implemented a surgical checklist that can be
        useful in reducing the risk of unidentified difficulties.
  
        The same suggestion has been included in the Helsinki Declaration on Patient Safety in
        Anaesthesiology, signed by most European entities in cooperation with the European Society of
        Anaesthesiology (ESA), the European Board of Anaesthesiology (EBA-UEMS), and the World
        Federation of Societies of Anaesthesiology (WFA).
  
        Confirmation of correct endotracheal tube (ET) placement is a crucial step in airway
        management, as unrecognised oesophageal intubation can have catastrophic consequences.
        Numerous methods are used to verify correct ET placement, including visual confirmation of
        tube passage through the vocal cords during laryngoscopy, chest wall expansion during
        ventilation, visualisation of the tracheal rings and carina using a flexible bronchoscope,
        auscultation, capnometry, capnography and chest radiography. These techniques vary in their
        degree of precision. Although capnography is considered the gold standard for confirming
        tracheal intubation, it has some important limitations.
  
        In recent years, ultrasonography has been introduced as the fifth pillar of the physical
        examination of the patient: inspection, palpation, percussion, auscultation and insonation.
        For airway assessment and management, Point-of-Care UltraSound (PoCUS) has been incorporated
        into routine clinical practice, answering open diagnostic questions, aiding in differential
        diagnosis and guiding procedures.
  
        Thus, investigators propose a simple, quick and easy-to-learn approach for the interpretation
        of ultrasound imaging findings during airway management.
  The first step of the algorithm is to locate the oesophagus by asking the patient to swallow.
        The ultrasound transducer is placed transversely on the anterior surface of the neck at the
        paratracheal level (usually located on the left side), 1-2 cm above the sternal notch or
        jugulum. In this image, the trachea is shown as a hyperechoic, curvilinear image (air-mucosa
        interface), showing a posterior reverberation artefact called a comet tail. During the
        intubation technique, this ultrasound window allows the physician to observe the real-time
        passage of the tube into the trachea, confirming correct tracheal intubation only if a single
        air-mucosa interface with its comet tail is maintained. This can then be verified by
        capnography (if available) or by lung sliding.
  observational model: Other
  time perspective: Prospective
  measure: Ultrasound Oesophageal Intubation
  time frame: 5 minutes
  description: To assess a diagnostic algorithm for tracheal versus oesophageal intubation using ultrasound and capnography as a confirmatory criterion.
  measure: POCUS learning curve
  time frame: 30 minutes
  description: Time required for the application of the ultrasound algorithm and training time for previously untrained personnel.
  arm group label: Patients undergoing scheduled and/or emergency surgery requiring orotracheal intubation.
  intervention type: Diagnostic Test
  intervention name: Ultrasound Oesophageal Intubation
  description: Ultrasound Oesophageal intubation detection
  arm group label: Patients undergoing scheduled and/or emergency surgery requiring orotracheal intubation.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: It is not neccessary to share any data.