Electromagnetic (EM) guided bedside placement of a nasoenteral feeding tube is at least as effective as endoscopic placement at lower costs.
ID
Bron
Verkorte titel
Aandoening
EN: Gastroparesis, delayed gastric emptying, surgery, nasoenteral feeding, endoscopy, electomagnetic guidance
NL: Gastroparese, vertraagde maagontlediging, chirurgie, sondevoeding, endoscopie, elektromagnetische geleiding
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome is reinsertion of a feeding tube via the nose and oesophagus (either after initial unsuccessful placement or after dislodgement or blockage of an initially successfully placed tube).
Achtergrond van het onderzoek
Subjects will be recruited in the Netherlands in the AMC Amsterdam, UMC Utrecht, Gelre Hospital Apeldoorn, CWZ Nijmegen and Gelderse Vallei Ede.
Doel van het onderzoek
Electromagnetic (EM) guided bedside placement of a nasoenteral feeding tube is at least as effective as endoscopic placement at lower costs.
Onderzoeksopzet
Both patient groups are followed for as long as they are hospitalized and during any outpatient department or day-care visit related to the tube.
Onderzoeksproduct en/of interventie
Intervention: EM-guided bedside nasoenteral feeding tube placement by a trained nurse on the clinical ward.
Comparison: Endoscopic nasoenteral feeding tube placement by a gastroenterologist in the endoscopy department.
Publiek
Postbus 22660
A. Gerritsen
Amsterdam 1100 DD
The Netherlands
arjagerritsen@core-trial.nl
Wetenschappelijk
Postbus 22660
A. Gerritsen
Amsterdam 1100 DD
The Netherlands
arjagerritsen@core-trial.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4276 |
| NTR-old | NTR4420 |
| CCMO | NL47229.018.13 |
| OMON | NL-OMON40389 |