to determine the accuracy/reliability of ultrasound in determining the correct placement of gastric feeding tube expressed as the sensitivity and specificity for this diagnostic test.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
IC patienten onder sedatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
One of the indications for an X-ray in the ICU is to determine the correct
position of the feeding tube in the stomach. Undetected misplacement of the
feeding tube in the airway is potentially life-threatening. The use of doppler
ultrasound of the stomach could be a good candidate to replace the CXR, but
this has not been extensively studied before (1). An ultrasound has several
advantages over a CXR. First, it is a bedside diagnostic method that does not
require expertise or personnel from outside the ICU and uses equipment already
present in a modern ICU. Second, it is safe and has no side effects for the
patient or the ultrasound technician. Finally, because the equipment is already
present in the intensive care unit, it does not involve any additional cost,
whereas a CXR costs about 100 euros (we perform about 2500 CXRs in the ICU
every year).
Study objective
to determine the accuracy/reliability of ultrasound in determining the correct
placement of gastric feeding tube expressed as the sensitivity and specificity
for this diagnostic test.
Study design
A diagnostic study, studying the efficacy of ultrasound in determining the
correct placement of the gastric feeding tube in all intensive care patients
having or needing one. Patients will get a newly placed gastric feeding tube
(GFT) as part of our standard care when admitted to the ICU or a replacement
when a new GFT is needed.
When a new GFT is placed or replaced, its position will be determined with the
use of ultrasound by a *blinded *ultrasonographer (USG). The USG will repeat
the same ultrasonographic measurement with every GFT placement i.e. the
presence or absence of a doppler enhancement signal. The presence of the latter
indicates the presence of the GFT in the stomach. Every patient will ultimately
receive a GFT in the proper position ( tested with a CXR), but in order to test
the sensitivity and specificity of the ultrasound test we want to perform the
test with the GFT localized at midesophageal level (±30cm), gastric level (±50
cm) and tracheobronchial position ( via suction catheter). To test the latter,
the trachea of the patient will be injected with 20mL of air through a suction
catheter guided through the tracheal tube, while the blinded USG determines the
presence or absence of the doppler signal enhancement. The suction catheter in
the tracheal tube (similar caliber to the GFT in diameter) is routinely placed
as a part of routine care directly after intubation in order to suction
secretions in the tracheobronchial system.
We hypothesize that a 20mL air insufflation via a GFT at esophageal level or
via a suction catheter in the tracheobronchial system will not show a doppler
enhancement signal on ultrasound. This sign will only be objectivized if the
GFT is properly positioned in the stomach.
Every patient needing a GFT will be randomized to three different sequences of
placement checking.
Intervention
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 localization varies between patients
and is randomized. The ultrasound technician doing the monitoring is blinded.
Study burden and risks
Burden and risks to the patient are considered minimaal. Patients are already
deeply sedated because of the need of intubation so the burden for the gastric
tube placement which will happen as part of the standard care is minimaal. The
risks of 20cc air insuflation in trachea, oesofagus and stomach are considered
negligible.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL79866.058.22 |