Comparison of Two Endoscopically Placed Nasojejunal Probes

Study Overview
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Brief Summary
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A direct application of jejunal tube feeding is necessary especially in patients with gastroparesis due of existing diabetes mellitus, postoperative or severe underlying disease. Since the jejunal tube feedings, the secretion of gastric juice can be increased, the use of probes that allow both: jejunal nutrition, as well as a gastric outflow of secretions are beneficial. While in a randomized trial of Schwab et al. it could be shown that the use of Freka-Trilumina® compared to Dobbhoff probe by so-called drag technique is significantly faster there are currently no comparative data to use the Easy-In® probe subsequently developed , which is directly introduced through the working channel of the endoscope, and thus shortening the procedure time.

Detailed Description
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The use of probes nasojejunal has increasingly become important especially in critically ill patients because of the beneficial effect in patients e.g. with necrotizing pancreatitis, according trauma or major surgical procedures. A direct application of jejunal tube feeding is necessary especially in patients with gastroparesis due of existing diabetes mellitus, postoperative or severe underlying disease. Since the jejunal tube feedings, the secretion of gastric juice can be increased, the use of probes that allow both: jejunal nutrition, as well as a gastric outflow of secretions are beneficial. While in a randomized trial of Schwab et al. it could be shown that the use of Freka-Trilumina® compared to Dobbhoff probe by so-called drag technique is significantly faster there are currently no comparative data to use the Easy-In® probe subsequently developed , which is directly introduced through the working channel of the endoscope, and thus shortening the procedure time. In the presented study should be investigated to what extent the use of imported directly via the working channel Easy-Inn® probe, application time and thus the investigation period may be shortened compared to the usual nasojenunal probes.

Official Title
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Randomized, Controlled Comparison of Two Endoscopically Placed Nasojejunal Probes in Critically Ill Patients in Terms of Application Time and Technical Success

Conditions
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Investigation Time

Intervention / Treatment
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* Device: Freka®-Trilumina versus Freka®-EasyIn


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Clinical indication for enteral feeding via naso-jejunal probe Exclusion Criteria: Lack of consent of the patient or their relatives (in intubated and mechanically ventilated patients in intensive care)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>After randomization one half of the patients receive a Freka®-Trilumina probe, which is inserted in nasogastric route an then pushed  using a small forceps which is inserted through the endoscope into the small intestine. | Device: Freka®-Trilumina versus Freka®-EasyIn<br>* Direct placement of probe via endoscope<br>|
| Experimental: Freka®-EasyIn<br>The other half of the patients will receive a Freka®-EasyIn probe which is directly placed in the small intestine inserted over the endoscope, after endoscopy was initially pushed - as far as possible - into the small intestine. | Device: Freka®-Trilumina versus Freka®-EasyIn<br>* Direct placement of probe via endoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination time for the probe system |  | Through study completion, an average of 1 year |