To determine the (cost-)effectiveness and budget impact EM-guided bedside placement as compared to endoscopic placement of a nasoenteral feeding tube in surgical patients.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is reinsertion of the feeding tube via the nose and oesophagus
(either after initial unsuccessful placement or after dislodgement or blockage
of an initially successfully placed tube).
Secondary outcome
Secondary outcomes are amongst others: patient discomfort and satisfaction,
costs, budget impact, success rate of tube placement, duration of procedure,
time lapse between physician order and tube placement and feed initiation, time
to full-dose enteral nutrition, feeding-related interventions, length of tube
stay, tube-related morbidity and length of hospital stay.
Background summary
In surgical patients there is a frequent need for post-pyloric feeding, mainly
because of gastroparesis. In these patients a nasoenteral feeding tube is
placed by a gastroenterologist in the endoscopy unit. Endoscopic tube placement
is labour-intensive and uncomfortable and cumbersome for patients. Moreover,
feeding tubes often tend to dislodge, requiring replacement of the tube. This
is associated with discomfort for the patient and a temporary decrease in
enteral intake, but also with an increase in work demand for nursing staff,
medical staff and additional costs. Non-endoscopic bedside electromagnetic (EM)
guided (using the Cortrak® Enteral Access System) placement of nasoenteral
feeding tubes can potentially offer some major patient-comfort related and
financial advantages compared to endoscopic placement.
Study objective
To determine the (cost-)effectiveness and budget impact EM-guided bedside
placement as compared to endoscopic placement of a nasoenteral feeding tube in
surgical patients.
Study design
A parallel-group, pragmatic, multicenter randomized controlled non-inferiority
trial in four Dutch hospitals (1 university, 3 teaching hospitals)
Intervention
EM-guided bedside nasoenteral feeding tube placement by a trained nurse on the
clinical ward as compared to endoscopic nasoenteral feeding tube placement by a
gastroenterologist in the endoscopy department.
Study burden and risks
There are no burdens or risks associated with participation in the study. A
potential benefit can be that patients in the intervention arm will undergo an
even less invasive procedure as compared to patients in the comparison arm
undergoing the current standard procedure. Moreover they will not have to be
exposed to radiation. No blood samples will be drawn. Patients will be asked to
complete a short questionnaire after each (re)placement procedure.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients:
- Admitted on a gastrointestinal surgical ward
- Requiring post-pyloric enteral nutrition, because of severe gastroparesis/gastric stasis not responding to prokinetics, intolerance of oral feeding due to gastroduodenal inflammation, postprandial pain or passage disorder due to swelling or outside pressure onto the duodenum, or proximal enteric fistulae.
- For UMC Utrecht and St.Antonius Hospital: After previous gastrointestinal, HPB or splenic surgery
Exclusion criteria
Patients:
- Younger than 18 years
- Contraindication for enteral feeding
- History of oesophageal varices, stenosis or obstruction of the upper digestive tract or recent oesophagectomy
- Presence of an implanted medical device that may be affected by electromagnetic field of the Cortrak system or vice versa (except for pacemakers and defibrillators)
- Necessity for tube placement during weekends or holidays
- Unable to provide informed consent
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL47229.018.13 |
| OMON | NL-OMON26355 |