Comparison of Two Endoscopically Placed Nasojejunal Probes

Sponsor
Ruhr University of Bochum (Other)
Overall Status
Unknown status
CT.gov ID
NCT02705027
Collaborator
(none)
64
2
2
48
32
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Freka®-Trilumina versus Freka®-EasyIn
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Randomized, Controlled Comparison of Two Endoscopically Placed Nasojejunal Probes in Critically Ill Patients in Terms of Application Time and Technical Success
Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Jul 1, 2016
Anticipated Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard

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
Direct placement of probe via endoscope

Experimental: Freka®-EasyIn

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
Direct placement of probe via endoscope

Outcome Measures

Primary Outcome Measures

  1. Examination time for the probe system [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 PD Dr. Andrea Riphaus Hannover Germany 30161
2 Klinikum Agness Karll Laatzen Laatzen Germany 30880

Sponsors and Collaborators

  • Ruhr University of Bochum

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Andrea Riphaus, PD Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT02705027
Other Study ID Numbers:
  • 3967-11
First Posted:
Mar 10, 2016
Last Update Posted:
Mar 10, 2016
Last Verified:
Feb 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Mar 10, 2016