Gastric Ultrasound Feeding Tube Placement Confirmation Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Need a gastric feeding tube
Given informed consent directly
Does not need a gastric feeding tube and doesn't have one.
Laparotomy wound interfering with abdominal ultrasound.
Trial population
The study population consists of tracheally intubated ICU patients in need of GFT placement or replacement, who are willing to participate in the study and provide informed consent.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Hand held ultrasound
DeviceDetermination of gastric feeding tube position with the use of Lumify handheld ultrasound
Treatment groups
58 Participants
are divided into 1 treatment groupGroup A: Ultrasound control of air insufflation in tracheobronchial suction catheter, oesofagus and stomach1 intervention
Trial outcomes
Primary outcomes
1
Test effectiveness of ultrasound in determining gastric feeding tube position in stomach.
To assess the effectiveness of the test we will calculate its sensitivity and specificity. Sensitivity in this case being the proportion of images categorized as having a "mosaic sign present" by the blinded intensivist and indeed representing a gastric GFT localisation (objectivized by CXR). Specificty being the proportion of images categorized as "mosaic sign absent" and representing a non-gastric GFT localisation ( Air insuflation at 20cm GFT insertion and in tracheal canula (TB)). Sensitvity and Specificity will be expressed as a percentage as well as false positive and false negative rates. With this information we will be able to calculate the Likelihood Ratio (LR) for a positive result and for a negative result. The analysis will be done using the statistical program SPSS.
Time frame
ultrasound control of gastric feeding tube, confirming with X-raySecondary outcomes
1
Correlating results with basline patient demographic, ventilator settings and post procedure chest x-ray findings.
Correlation of false positive and false negative results with demographic parameters, ventilator settings and chest x-ray findings.
Time frame
baseline and post procedure ( gastric feeding tube) chest x-raySponsors and contacts
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Source ClinicalTrials.gov