Comparison of Two Endoscopically Placed Nasojejunal Probes

Ruhr University of Bochum

Status: Unknown

Conditions: Investigation Time

Treatments: Device: Freka®-Trilumina versus Freka®-EasyIn

Study type: Interventional

Funder types: Other

Identifiers

NCT02705027

3967-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

64 participants in 2 patient groups

Standard

Active Comparator group

Description:

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.

Treatment:

Device: Freka®-Trilumina versus Freka®-EasyIn

Freka®-EasyIn

Experimental group

Description:

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.

Treatment:

Device: Freka®-Trilumina versus Freka®-EasyIn