US-FEED: Bedside Ultrasound Assessment of Feeding Tube Position in the Intensive Care Unit

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Recruiting
CT.gov ID
NCT06077617
Collaborator
(none)
423
1
27.8
15.2

Study Details

Study Description

Brief Summary

This diagnostic accuracy study aims to evaluate the performance of bedside ultrasound compared to x-ray in detecting the correct position of feeding tubes among critically ill adult patients. The main questions it aims to answer are: • diagnostic accuracy of bedside ultrasound • feasibility of its wide adoption among practitioners with minimal training in busy intensive care units.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This multicenter diagnostic accuracy study consists of a non-consecutive convenience sample of adult patients admitted to the intensive care unit starting from March 2023 who require a feeding tube as defined by the medical attending team.

    Right after feeding tube placement following the institutional standard operating procedure, attending physicians perform bedside ultrasound assessment to verify the correct position of the tube. They report whether or not visualizing the feeding tube in four steps: 1) in the esophagus from either the right or left side of the patient's neck; 2) in the transverse view of the patient's epigastrium; 3) in the longitudinal view of the patient's epigastrium and 4) during the injection of 20 mL of air into the tube to detect the 'fogging sign.' Finally, the abdominal radiograph (gold standard) confirms the gastric or duodenal placement of the feeding tube.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    423 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Bedside Ultrasound Assessment of Feeding Tube Position in the Intensive Care Unit: the US-FEED Study
    Actual Study Start Date :
    Mar 24, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Jul 16, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Diagnostic group

    Adult ICU patients submitted to feeding tube placement according to institutional standard operating procedure

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic accuracy [The expected time between ultrasound assessment and abdominal radiography is under 2 hours..]

      Estimating sensitivity, specificity, positive predictive rate, negative predictive rate, and total accuracy of bedside ultrasound compared with abdominal radiography (gold standard). A receiver operating characteristic (ROC) curve will display the discriminatory properties of the ultrasound assessment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age greater than or equal to 18 years old;

    • Need for a tube feeding for receiving diet and/or medication, as indicated by the medical team;

    • Blind insertion of a tube feeding in the intensive care unit, following the standard operating procedure;

    • Presence of a trained physician for ultrasound scanning of the tube feeding immediately after installation.

    Exclusion Criteria:
    • Major abdominal postoperative wounds, peritoneostomy, or any other conditions that preclude ultrasound abdominal examination;

    • Exclusive presence of a gastric decompression probe, which does not require radiographic confirmation;

    • Tube feeding introduced under digestive endoscopy guidance;

    • Gestation;

    • Abdominal radiography confirming the tube position obtained before the ultrasound assessment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul Brazil 90035-003

    Sponsors and Collaborators

    • Hospital de Clinicas de Porto Alegre

    Investigators

    • Principal Investigator: Ana Carolina P Antonio, PhD, HCPorto Alegre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital de Clinicas de Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT06077617
    Other Study ID Numbers:
    • 2022-0627
    First Posted:
    Oct 11, 2023
    Last Update Posted:
    Oct 11, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2023