Comparison of Two Endoscopically Placed Nasojejunal Probes

Investigation Time Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705027
• Other study ID #: 3967-11
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2016
• Last updated: March 5, 2016
• Start date: August 2012
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Ruhr University of Bochum
• Contact: Andrea Riphaus, MD, PhD
• Phone: +49-511-8208
• Email: ariphaus[@]web.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Investigation Time

Intervention

Device:
• Freka®-Trilumina versus Freka®-EasyIn
Direct placement of probe via endoscope

Locations

Country	Name	City	State
Germany	PD Dr. Andrea Riphaus	Hannover
Germany	Klinikum Agness Karll Laatzen	Laatzen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schwab D, Mühldorfer S, Nusko G, Radespiel-Tröger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination time for the probe system		Through study completion, an average of 1 year	No