Actively Recruiting

Age: 18Years +
All Genders
ID06595537

Gastric Ultrasound Feeding Tube Placement Confirmation Study

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

58

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the accuracy and reliability of ultrasound Doppler for confirming the correct placement of gastric feeding tubes (GFTs) in intensive care unit (ICU) patients. The study compares ultrasound results to the standard method of chest X-ray (CXR) to see if ultrasound can safely and effectively determine GFT positioning. This research focuses on ICU patients who are intubated and require GFT placement or replacement. Patients will receive a gastric feeding tube, and ultrasound imaging will be performed at both the mid-esophagus and stomach levels using a handheld device. During ultrasound, 20 mL of air will be insufflated through the GFT or a suction catheter in the trachea to look for a specific "mosaic sign" that indicates correct placement in the stomach. These ultrasound images will be anonymized and reviewed by an expert intensivist, then compared to chest X-ray findings. Participants will undergo ultrasound and chest X-ray assessments after GFT placement or replacement. Data collected includes ultrasound images, patient details, ventilator settings, and chest X-ray results. Researchers will monitor safety by recording any adverse events. The main goal is to test how well ultrasound detects proper GFT position. The study is expected to last until August 2025, with ongoing data collection and monitoring during this time.

CONDITIONS

Brief 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 that needs replacement or require a new 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
  • Has a laparotomy wound interfering with abdominal ultrasound
  • Is in the prone position
  • Has not provided informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility assessment

Diagnostic Evaluation

Duration - 1 day

Participants undergo ultrasound Doppler and chest X-ray to confirm the placement of gastric feeding tubes.

1 visit (in-person) including ultrasound and chest X-ray

Long-term Monitoring

Duration - Up to 1 week

Participants are observed for safety and correlation between ultrasound results and patient characteristics.

Monitoring during ICU stay as per routine care

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.

D

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

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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Published Research Related To This Trial

The effectiveness of ultrasonography in verifying the placement of a nasogastric tube in patients with low consciousness at an emergency center.

Hyung Min Kim, Byung Hak So, Won Jung Jeong...

https://pubmed.ncbi.nlm.nih.gov/22691418