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Is Ultrasound Comparable to Chest X-ray in Verification of Intensive Care Patients Enteral Feeding Tube Positioning.

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06000384
Collaborator
(none)
20
Enrollment
62
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Aug 21, 2023
    Anticipated Primary Completion Date :
    Oct 21, 2023
    Anticipated Study Completion Date :
    Oct 21, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Measuring enteral tube position both by standard chest X-ray and ultrasound [maximum five minutes for each method]

      Ultrasound measure by a research based 4-step approach

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Intensive care patient prescribed by a medical physician to have an enteral feeding tube
    Exclusion Criteria:
    • <18 years

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Norwegian University of Science and Technology

    Investigators

    • Principal Investigator: Irene Lie, Professor, Norwegian University of Science and Technology - NTNU.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Irene Lie, Professor, Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT06000384
    Other Study ID Numbers:
    • REK-nr 590270
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Irene Lie, Professor, Norwegian University of Science and Technology
    Intensive care patient
    Enteral feeding tube

    Study Results

    No Results Posted as of Aug 21, 2023