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/NCT06002815</url>
    </required_header>
    <id_info>
      <org_study_id>2023.07.IRB.78</org_study_id>
      <nct_id>NCT06002815</nct_id>
    </id_info>
    <brief_title>Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients</brief_title>
    <official_title>Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taksim Egitim ve Arastirma Hastanesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taksim Egitim ve Arastirma Hastanesi</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>
        This research aims to investigate potential variations in the success rate and occurrence of&#xD;
        complications during nasogastric tube insertion between Difficult and Easy Airway Patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who are scheduled for surgery for any reason and who will receive general anesthesia&#xD;
        requiring perioperative nasogastric tube insertion will be included in the study. Two groups&#xD;
        will be formed, the easy airway group and the difficult airway group. The main aim is to&#xD;
        investigate whether there is a difference between the groups in terms of the success of&#xD;
        insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of&#xD;
        insertion. Investigating the differences between the groups in terms of complications such as&#xD;
        bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a&#xD;
        secondary aim. At the end of the study, determining the correlation between the failure of&#xD;
        nasogastric tube insertion and difficult airway parameters is planned as another secondary&#xD;
        goal.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">December 28, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 28, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Comparison of Nasogastric Tube Insertion in Difficult and Easy Airway Patients</measure>
      <time_frame>10 minutes</time_frame>
      <description>The main aim was to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complications in Difficult and Easy Airway Patients</measure>
      <time_frame>5 minutes</time_frame>
      <description>Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Airway parameters and failure of nasogastric tube insertion</measure>
      <time_frame>10 minutes</time_frame>
      <description>Determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">244</enrollment>
    <condition>Intubation; Difficult or Failed</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who are scheduled for surgery for any reason and who will receive general&#xD;
          anesthesia requiring perioperative nasogastric tube insertion will be included in the&#xD;
          study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria: Patients who are scheduled for surgery for any reason and who will&#xD;
          receive general anesthesia requiring perioperative nasogastric tube insertion will be&#xD;
          included in the study.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under 18 year-old&#xD;
  &#xD;
            -  Patients who do not require nasogastric tube insertion&#xD;
  &#xD;
            -  Patients with anatomical changes in the head and neck region&#xD;
  &#xD;
            -  Patients without an informed consent form&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Celal Kaya, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Taksim Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Celal Kaya, MD</last_name>
      <phone>905435176760</phone>
      <email>c.kaya47@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rahime Aydinli, MD</last_name>
      <phone>905054835469</phone>
      <email>rahimeaydinli78@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Taksim Training and Research Hospital</name>
        <address>
          <city>Istanbul</city>
          <state>Please Select</state>
          <zip>34433</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Celal Kaya, MD</last_name>
        <phone>905435176760</phone>
        <email>c.kaya47@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Rahime Aydinli, MD</last_name>
        <phone>905054835469</phone>
        <email>rahimeaydinli78@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>It is not yet known if there will be a plan to make IPD available.</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/NCT06002815
  org study id: 2023.07.IRB.78
  nct id: NCT06002815
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research aims to investigate potential variations in the success rate and occurrence of
        complications during nasogastric tube insertion between Difficult and Easy Airway Patients.
  Patients who are scheduled for surgery for any reason and who will receive general anesthesia
        requiring perioperative nasogastric tube insertion will be included in the study. Two groups
        will be formed, the easy airway group and the difficult airway group. The main aim is to
        investigate whether there is a difference between the groups in terms of the success of
        insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of
        insertion. Investigating the differences between the groups in terms of complications such as
        bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a
        secondary aim. At the end of the study, determining the correlation between the failure of
        nasogastric tube insertion and difficult airway parameters is planned as another secondary
        goal.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Comparison of Nasogastric Tube Insertion in Difficult and Easy Airway Patients
  time frame: 10 minutes
  description: The main aim was to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion
  measure: Complications in Difficult and Easy Airway Patients
  time frame: 5 minutes
  description: Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim
  measure: Airway parameters and failure of nasogastric tube insertion
  time frame: 10 minutes
  description: Determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Celal Kaya, MD
  role: Principal Investigator
  affiliation: Taksim Training and Research Hospital
  last name: Celal Kaya, MD
  phone: 905435176760
  email: c.kaya47@hotmail.com
  last name: Rahime Aydinli, MD
  phone: 905054835469
  email: rahimeaydinli78@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Turkey
  responsible party type: Sponsor
  sharing ipd: Undecided
  ipd description: It is not yet known if there will be a plan to make IPD available.