All patients with an indication for duodenal feeding tube placement due to delayed gastric emptying at the endoscopy unit or ICU are eligible for this study.
Conditions
Interventions
Patients are randomized for electromagnetically visualized duodenal feeding tube placement with the CORTRAK system or duodenal feeding tube placement using endoscopy. The CORTRAK system (CORPAK MedSys
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: -All patients needing a duodenal feeding tube -Written informed consent provided by patient or representative -¡Ý18 years
Exclusion criteria
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 duodenal feeding tube)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of duodenal feeding tube placement; defined as the tip of the tube placed postpyloric and into the duodenum as confirmed by an abdominal X-ray. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Costs associated with duodenal feeding tube placement, calculated by the costs of both procedures and associated complications. -Time to procedure, defined as time between request for duodenal feeding tube placement and actual start of procedure. -Time of procedure, defined as time from introduction of endoscope/Cortrak tube in the nose until fixation of the tube to the nose. -Evaluation endoscopist/nurse, as scored after the procedure on a 11-point Visual Analogue Scale -Accuracy of tip location with Cortrak, defined as percentage of agreement on tip location between Cortrak system and abdominal X-ray findings. Assessment of the X-ray will be performed by an independent physician not involved in the study. Tip position will be divided in stomach (S), pars superior of the duodenum (D I), pars descendens of the duodenum (D II), pars horizontalis of the duodenum (D III) and pars ascendens of the duodenum (D IV) -DFT tip location (DI ¨C DIV, jejunum), defined as the location of the tip of the DFT on abdominal X-ray for both endoscopic placement and CORTRAK placement. -Safety, defined as number of (serious) adverse events related to duodenal feeding tube placement within the first 10 days after placement. -Use of sedatives -Reintervention rate within 10 days, total number of reinterventions due to feeding tube migrations and/or feeding tube clogging. -Patient acceptance (in unsedated patients), as scored by the patient on a 11-point Visual Analogue Scale. | — |
Contacts
Public ContactW.F.W. Kappelle
P.O. box 85500 University Medical Center Utrecht Department of Gastroenterology & Hepatology Room F02.618
Outcome results
None listed