Gastric Ultrasound Feeding Tube placement confirmation Study. GUT Study

Recruiting

Conditions: IC patienten onder sedatie
nvt

Registration Number: NL-OMON53909

Lead Sponsor: Intensive care

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 58

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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