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Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial.

Gerritsen A, de Rooij T, Dijkgraaf MG, Busch OR, Bergman JJ, Ubbink DT, van Duijvendijk P, Erkelens GW, Molenaar IQ, Monkelbaan JF, Rosman C, Tan AC, Kruyt PM, Bac DJ, Mathus-Vliegen EM, Besselink MG - Trials (2015)

Bottom Line: Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients.Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube).Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. a.gerritsen@amc.nl.

ABSTRACT

Background: Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients. We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients, at lower costs.

Methods/design: The CORE trial is an investigator-initiated, parallel-group, pragmatic, multicenter randomized controlled non-inferiority trial. A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals, requiring nasoenteral feeding, will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement. Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube). Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications.

Discussion: The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement. The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes.

Trial registration: Dutch Trial Register: NTR4420 , date registered 5-feb-2014.

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Related in: MedlinePlus

The Cortrak® Enteral Access System (electromagnetic transmitting stylet, receiver unit and enteral feeding tube). The tip of the tube is displayed on the monitor as a red dot and a yellow line reflects the path of the tube. Image reproduced with permission of CORPAK MedSystems.
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Fig2: The Cortrak® Enteral Access System (electromagnetic transmitting stylet, receiver unit and enteral feeding tube). The tip of the tube is displayed on the monitor as a red dot and a yellow line reflects the path of the tube. Image reproduced with permission of CORPAK MedSystems.

Mentions: The feeding tube (Corflo® nasojejunal feeding tube, Corpak Medsystems, Wheeling, Ill, US) is placed by a trained nurse at the patient’s bedside on the clinical ward, with the patient in a supine position. If a nasogastric decompression tube is in place, it is advised, but not mandatory, to empty the stomach and remove the nasogastric tube before proceeding. Preprocedural fasting is not required. By using an electromagnetic transmitting stylet, the nurse can follow the path of the tip of the feeding tube on a monitor screen (Cortrak® Enteral Access System, Corpak Medsystems, Wheeling, Ill, US) (Figure 2). The stylet at the tip of the feeding tube transmits its signal to a receiver unit placed at the patient’s epigastric region. Both the stylet and the receiver unit are attached by a cable to the monitor unit, which provides a graphic display of the feeding tube tip location and the followed track. In the anterior view, the tube can be followed on its way through the esophagus, stomach, duodenum, and jejunum. In the depth cross-section, the passage of the tube from the pylorus into the duodenal bulb and the second part of the duodenum can be seen. The tube is advanced to a post-pyloric position, preferably near or beyond the duodenojejunal flexure. Adequate positioning is assessed by the path of the tube on the screen. Subsequently, the transmitting stylet is removed from the feeding tube. Finally, the tube is secured to the nostrils with tape. Abdominal radiographs are not used, as the Cortrak® Enteral Access System was shown to correlate with abdominal radiography in 99.5% of cases and is cleared by the Food and Drug Administration (FDA) for feeding tube placement confirmation [9,11]. The stylet is kept at the patient’s bedside in case repositioning of the nasoenteral tube is required. The procedure is abandoned if the tip of the tube has not passed the pylorus after 30 minutes. In case of failure of EM guided placement, patients allocated to EM guided bedside placement will undergo endoscopic placement. According to the intention-to-treat principles these patients will be analyzed in the EM guided group.Figure 2


Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial.

Gerritsen A, de Rooij T, Dijkgraaf MG, Busch OR, Bergman JJ, Ubbink DT, van Duijvendijk P, Erkelens GW, Molenaar IQ, Monkelbaan JF, Rosman C, Tan AC, Kruyt PM, Bac DJ, Mathus-Vliegen EM, Besselink MG - Trials (2015)

The Cortrak® Enteral Access System (electromagnetic transmitting stylet, receiver unit and enteral feeding tube). The tip of the tube is displayed on the monitor as a red dot and a yellow line reflects the path of the tube. Image reproduced with permission of CORPAK MedSystems.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4390000&req=5

Fig2: The Cortrak® Enteral Access System (electromagnetic transmitting stylet, receiver unit and enteral feeding tube). The tip of the tube is displayed on the monitor as a red dot and a yellow line reflects the path of the tube. Image reproduced with permission of CORPAK MedSystems.
Mentions: The feeding tube (Corflo® nasojejunal feeding tube, Corpak Medsystems, Wheeling, Ill, US) is placed by a trained nurse at the patient’s bedside on the clinical ward, with the patient in a supine position. If a nasogastric decompression tube is in place, it is advised, but not mandatory, to empty the stomach and remove the nasogastric tube before proceeding. Preprocedural fasting is not required. By using an electromagnetic transmitting stylet, the nurse can follow the path of the tip of the feeding tube on a monitor screen (Cortrak® Enteral Access System, Corpak Medsystems, Wheeling, Ill, US) (Figure 2). The stylet at the tip of the feeding tube transmits its signal to a receiver unit placed at the patient’s epigastric region. Both the stylet and the receiver unit are attached by a cable to the monitor unit, which provides a graphic display of the feeding tube tip location and the followed track. In the anterior view, the tube can be followed on its way through the esophagus, stomach, duodenum, and jejunum. In the depth cross-section, the passage of the tube from the pylorus into the duodenal bulb and the second part of the duodenum can be seen. The tube is advanced to a post-pyloric position, preferably near or beyond the duodenojejunal flexure. Adequate positioning is assessed by the path of the tube on the screen. Subsequently, the transmitting stylet is removed from the feeding tube. Finally, the tube is secured to the nostrils with tape. Abdominal radiographs are not used, as the Cortrak® Enteral Access System was shown to correlate with abdominal radiography in 99.5% of cases and is cleared by the Food and Drug Administration (FDA) for feeding tube placement confirmation [9,11]. The stylet is kept at the patient’s bedside in case repositioning of the nasoenteral tube is required. The procedure is abandoned if the tip of the tube has not passed the pylorus after 30 minutes. In case of failure of EM guided placement, patients allocated to EM guided bedside placement will undergo endoscopic placement. According to the intention-to-treat principles these patients will be analyzed in the EM guided group.Figure 2

Bottom Line: Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients.Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube).Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Academic Medical Center, PO Box 22660, , 1100 DD, Amsterdam, the Netherlands. a.gerritsen@amc.nl.

ABSTRACT

Background: Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients. We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients, at lower costs.

Methods/design: The CORE trial is an investigator-initiated, parallel-group, pragmatic, multicenter randomized controlled non-inferiority trial. A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals, requiring nasoenteral feeding, will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement. Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube). Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications.

Discussion: The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement. The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes.

Trial registration: Dutch Trial Register: NTR4420 , date registered 5-feb-2014.

Show MeSH
Related in: MedlinePlus