Comparison of Two Endoscopically Placed Nasojejunal Probes

March 5, 2016 updated by: Andrea Riphaus, Ruhr University of Bochum

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30161
        • Recruiting
        • PD Dr. Andrea Riphaus
        • Contact:
          • Andrea Riphaus, MD, PhD
          • Phone Number: 2400 0049-511-8208
          • Email: ariphaus@web.de
      • Laatzen, Germany, 30880
        • Recruiting
        • Klinikum Agness Karll Laatzen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 5, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 3967-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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