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RECRUITING
NCT06595537

Gastric Ultrasound Feeding Tube Placement Confirmation Study

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

58

Start Date

2023-12-18

Completion Date

2025-08

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DEVICE

Hand held ultrasound

Determination of gastric feeding tube position with the use of Lumify handheld ultrasound

Locations (1)

Ledien University Medical Center

Leiden, South Holland, Netherlands