NCT06595537 Gastric Ultrasound Feeding Tube Placement Confirmation Study
| NCT ID | NCT06595537 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Gastric Feeding Tubes |
| Study Type | OBSERVATIONAL |
| Enrollment | 58 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 58 participants in total. It began in 2023-12-18 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Jorge E Lopez Matta, M.D.
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06595537 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Feeding Tubes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06595537 currently recruiting?
Yes, NCT06595537 is actively recruiting participants. Contact the research team at J.E.Lopez_Matta@lumc.nl for enrollment information.
Where is the NCT06595537 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06595537 clinical trial?
NCT06595537 is sponsored by Leiden University Medical Center. The principal investigator is Jorge E Lopez Matta, M.D. at Leiden University Medical Center. The trial plans to enroll 58 participants.