Gastric Ultrasound Feeding Tube Placement Confirmation Study

Recruiting now

Conditions studied: Gastric Feeding Tubes, Ultrasound

In brief

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.

Key facts

Study ID

NCT06595537

Run by

Leiden University Medical Center

People needed

58

Starts

2023-12-18

Expected to finish

2025-08-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Being tracheally intubated
• Have a gastric feeding tube which needs replacement for any particular reason e.g the GFT is not functioning, has been displaced, and the patient has no exclusion criteria ( zie 4.3).
• Need a gastric feeding tube
• Given informed consent directly

You may not qualify if…

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

Where it is running

• Ledien University Medical Center — Leiden, South Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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