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Gastric Ultrasound Feeding Tube placement confirmation Study. GUT Study

Gastric Ultrasound Feeding Tube placement confirmation Study. GUT Study - GUT study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53909
Enrollment
58
Registered
2022-11-17
Start date
2023-12-15
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nvt

Interventions

Inject 20 cc of air into the trachea via a suction catheter localized in the endobronchial tube ( standard), inject 20 cc of air midesophageal and at stomach level. The order of air injection locali

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: patients that need a gastric feeding tube patients who need a new gastric feeding tube patients who have given informed consent

Exclusion criteria

Exclusion criteria: - Does not need a gastric feeding tube and doesn*t have one. - Laparotomy wound interfering with abdominal ultrasound. - Patient in prone position. - Has no informed consent

Design outcomes

Primary

MeasureTime frame
The result of the ultrasound image analysis done by the blinded intensivist in correlation with the golden standard (CXR) will be plotted in a 2x2 table of frequencies. To assess the effectiveness of the test we will calculate its sensitivity and specificity. Sensitivity being the proportion of images correctly categorized as having a "mosaic sign present* by the blinded intensivist out of all images representing a gastric GFT localisation (objectivized by CXR). Specificity being the proportion of images correctly categorized as *mosaic sign absent* out of all images representing a non-gastric GFT localisation.The latter is our primary study parameter to ensure a minimal of false positive results. The analysis will be done using the statistical program SPSS.

Secondary

MeasureTime frame
Incorrect test results will analysed for a possible correlation to clincal data; patient gender, BMI, PEEP( positive end expiratory pressure), tidal volume, and presence of abdominal gas in left upper quadrant (gastric region) in CXR using logistic regression. These specific clinical parameters have been chosen because they could potentially have influence on the quality of the ultrasound images produced and therefore on the interpretation of the latter. Logistic regression calculations will be performed with the use of the statistical program SPSS.

Countries

Netherlands

Contacts

Public ContactJ.E.LM Lopez Matta

Leids Universitair Medisch Centrum

J.E.Lopez_Matta@lumc.nl0625214588

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026