Clinical trial NCT02705027: Comparison of Two Endoscopically Placed Nasojejunal Probes
Official title: Randomized, Controlled Comparison of Two Endoscopically Placed Nasojejunal Probes in Critically Ill Patients in Terms of Application Time and Technical Success
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Investigation Time
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Examination time for the probe system
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: PD Dr. Andrea Riphaus
city: Laatzen
country: Germany
facility: Klinikum Agness Karll Laatzen
Study officials:
References:
citation: Schwab D, Muhldorfer S, Nusko G, Radespiel-Troger M, Hahn EG, Strauss R. Endoscopic placement of nasojejunal tubes: a randomized, controlled, prospective trial comparing suitability and technical success for two different tubes. Gastrointest Endosc. 2002 Dec;56(6):858-63. doi: 10.1067/mge.2002.129870.