Actively Recruiting

Age: 18Years +
All Genders
NCT06595537

Gastric Ultrasound Feeding Tube Placement Confirmation Study

Led by Leiden University Medical Center · Updated on 2024-09-19

58

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Objective This study aims to assess the accuracy and reliability of ultrasound in determining the correct placement of gastric feeding tubes (GFTs) in intensive care patients. Study Design A diagnostic study will be conducted to evaluate the efficacy of ultrasound in determining GFT placement in all ICU patients who require GFT placement. Patients will undergo ultrasound by an ultrasonographer (USG) after receiving a new or replaced GFT. The USG will assess the presence or absence of a "mosaic sign" after insufflation of 20 mL of air through the GFT. The mosaic sign indicates proper GFT placement in the stomach. Methods All ultrasonographic measurements will be recorded and saved in a central picture archiving and communication system (PACS). The images will be labeled with the deepness of the GFT (20 cm, 50 cm, or tracheobronchial) and anonymized before being presented to an intensivist expert in USG for interpretation. Hypothesis A 20 mL air insufflation via a GFT at the esophageal level or via a suction catheter in the tracheobronchial system will not produce a "mosaic sign" on ultrasound. This sign will only be present if the GFT is properly positioned in the stomach.

CONDITIONS

Official Title

Gastric Ultrasound Feeding Tube Placement Confirmation Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Being tracheally intubated
  • Have a gastric feeding tube which needs replacement for any particular reason (e.g., not functioning or displaced)
  • Need a gastric feeding tube
  • Provided informed consent directly
Not Eligible

You will not qualify if you...

  • Does not need a gastric feeding tube and does not have one
  • Laparotomy wound interfering with abdominal ultrasound
  • Patient in prone position
  • No informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ledien University Medical Center

Leiden, South Holland, Netherlands, 2315VA

Actively Recruiting

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Research Team

J

Jorge E. Lopez Matta, M.D.

CONTACT

D

David J. Van Westerloo, M.D., pHD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Gastric Ultrasound Feeding Tube Placement Confirmation Study | DecenTrialz