Compare the success rate of duodenal feeding tube placement using the CORTRAK system (DFT-C) with the endoscopic technique (DFT-E).
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Success rate of DFT placement; defined as the tip of the tube placed
postpyloric and into the duodenum as confirmed by an abdominal X-ray.
Secondary outcome
Costs associated with DFT placement, procedure time, difficulty of the
procedure, accuracy of tip location with CORTRAK, DFT tip location, safety, use
of sedatives, reintervention rate within 10 days and patient acceptance (in
unsedated patients).
Background summary
Increasing evidence confirms the important role of enteral feeding in
(critically ill) patients. A substantial part of these patients have an
indication for duodenal or jejunal feeding. However, duodenal feeding tube
(DFT) placement can be difficult, time-consuming, or costly, depending on the
technique used. Endoscopic tube placement has high success rates, but the
availability of appropriate staff and specialized equipment is required for
this technique, making this technique costly and difficult to provide
consistently. Several other techniques for DFT placement have been assessed,
all require a high level of expertise and most have not been compared with the
endoscopic technique. An electromagnetic tube placement device, the CORTRAK
system, is increasing in popularity and several observational studies have
demonstrated this technique to be safe, efficient, and cost-effective. Only two
small studies have compared the CORTRAK system with other placement techniques
in a controlled setting.
Study objective
Compare the success rate of duodenal feeding tube placement using the CORTRAK
system (DFT-C) with the endoscopic technique (DFT-E).
Study design
Randomized sequential prospective, multicenter, non-blind, controlled trial.
Intervention
Patients will be randomized to undergo DFT placement with the CORTRAK system or
the endoscopic technique.
Study burden and risks
The risk for complications when performing DFT placement with the CORTRAK
system is probably lower since fewer sedatives will be used. Possible
complications are epistaxis, inadvertent passage of the feeding tube into the
respiratory tract, aspiration and unsuccessful placement of the feeding tube.
There are no guaranteed benefits of participation for the subject, though the
burden of participating is negligible. Possible benefits of DFT placement with
the CORTRAK system are less need for sedation and less complications due to
sedation, cost reduction due to savings on staff and equipment and a simplified
logistics that might result in more prompt initiation of enteral feeding with
all the benefits of early start of enteral feeding.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- All patients needing a duodenal feeding tube
- Written informed consent provided by patient or representative
- *18 years
Exclusion criteria
- Implantable pacing devices (potential interference with the signal transmission)
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus,
stomach or duodenum
- High suspicion of stenosis or obstruction in the upper digestive tract
- Esophageal varices
- Signs of active upper gastrointestinal bleeding.
- Woman with known pregnancy (because of abdominal X-rays performed in order to confirm location of the DFT)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42753.041.12 |