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/NCT06000384</url>
    </required_header>
    <id_info>
      <org_study_id>REK-nr 590270</org_study_id>
      <nct_id>NCT06000384</nct_id>
    </id_info>
    <brief_title>Is Ultrasound Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning.</brief_title>
    <official_title>Investigate if Ultrasound is Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning in an Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Norwegian University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Norwegian University of Science and Technology</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 goal of this observational study is to investigate methodological if ultrasound is&#xD;
        comparable to chest X-ray in verification of intensive care patients enteral feeding tube&#xD;
        positioning.&#xD;
  &#xD;
        The main question to answer is: Is ultrasound a comparable method to chest X-ray in&#xD;
        verification of intensive care patients enteral feeding tube positioning.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In Norway, around 4000 patients are yearly in need of ventilator, and many of them will need&#xD;
        enteral nutrition through a feeding tube. 40 % of all intensive care patients have signs of&#xD;
        malnutrition. If ultrasound is a comparable method to chest X-ray in verification of&#xD;
        intensive care patients enteral feeding tube positioning, then enteral nutrition in many&#xD;
        cases can be started several hours earlier than using chest X-ray verification. The&#xD;
        ultrasound examination will be performed in a research based in a 4-step approach. In this&#xD;
        project 20-30 intensive care patients prescribed by a medical physician to have an enteral&#xD;
        feeding tube will be included in the project due to written informed consent by 1) Awake&#xD;
        intensive care patient or by 2) Patients informal caregiver if the patient is not competent&#xD;
        to consent.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 15, 2023</start_date>
    <completion_date type="Anticipated">November 15, 2028</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</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>Measuring enteral tube position both by standard chest X-ray and ultrasound</measure>
      <time_frame>maximum five minutes for each method</time_frame>
      <description>Ultrasound measure by a research based 4-step approach</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Intensive Care Patient</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Intensive care patients in need of enteral tube feeding&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Intensive care patient prescribed by a medical physician to have an enteral feeding&#xD;
               tube&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years&#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>Irene Lie, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Norwegian University of Science and Technology - NTNU.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Irene Lie, Professor</last_name>
      <phone>99026729</phone>
      <email>Irene.lie@ntnu.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sina Sagbakken, Masterst</last_name>
      <email>sinabs@stud.ntnu.no</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Lillehammer sykehus, Sykehuset Innlandet</name>
        <address>
          <city>Lillehammer</city>
          <state>Innlandet</state>
          <zip>2609</zip>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Baard Olav MD Jensen, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Norwegian University of Science and Technology</investigator_affiliation>
      <investigator_full_name>Irene Lie</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Intensive care patient</keyword>
    <keyword>Enteral feeding tube</keyword>
    <!-- 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/NCT06000384
  org study id: REK-nr 590270
  nct id: NCT06000384
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to investigate methodological if ultrasound is
        comparable to chest X-ray in verification of intensive care patients enteral feeding tube
        positioning.
  
        The main question to answer is: Is ultrasound a comparable method to chest X-ray in
        verification of intensive care patients enteral feeding tube positioning.
  In Norway, around 4000 patients are yearly in need of ventilator, and many of them will need
        enteral nutrition through a feeding tube. 40 % of all intensive care patients have signs of
        malnutrition. If ultrasound is a comparable method to chest X-ray in verification of
        intensive care patients enteral feeding tube positioning, then enteral nutrition in many
        cases can be started several hours earlier than using chest X-ray verification. The
        ultrasound examination will be performed in a research based in a 4-step approach. In this
        project 20-30 intensive care patients prescribed by a medical physician to have an enteral
        feeding tube will be included in the project due to written informed consent by 1) Awake
        intensive care patient or by 2) Patients informal caregiver if the patient is not competent
        to consent.
  observational model: Other
  time perspective: Prospective
  measure: Measuring enteral tube position both by standard chest X-ray and ultrasound
  time frame: maximum five minutes for each method
  description: Ultrasound measure by a research based 4-step approach
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Irene Lie, Professor
  role: Principal Investigator
  affiliation: Norwegian University of Science and Technology - NTNU.
  last name: Irene Lie, Professor
  phone: 99026729
  email: Irene.lie@ntnu.no
  last name: Sina Sagbakken, Masterst
  email: sinabs@stud.ntnu.no
  facility: 
  status: Recruiting
  contact: 
  country: Norway
  responsible party type: Principal Investigator
  investigator affiliation: Norwegian University of Science and Technology
  investigator full name: Irene Lie
  investigator title: Professor