Wouter F W Kappelle1, Daisy Walter1, Paul H Stadhouders2, Hendrik J A Jebbink3, Frank P Vleggaar1, Peter J van der Schaar2, Jan Willem Kappelle3, Ingeborg van der Tweel4, Medard F M Van den Broek2, Frank J Wessels5, Peter D Siersema6, Jan F Monkelbaan1. 1. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands. 2. Department of Gastroenterology and Hepatology, Sint Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands. 3. Department of Gastroenterology and Hepatology, Medical Center Leeuwarden, Leeuwarden, The Netherlands. 4. Department of Biostatistics, Julius Center, University Medical Center Utrecht, Utrecht, The Netherlands. 5. Department of Radiology, University Medical Center Utrecht, Utrecht, The Netherlands. 6. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands; Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
Abstract
BACKGROUND AND AIMS: Electromagnetic-guided placement (EMP) of a nasoduodenal feeding tube by trained nurses is an attractive alternative to EGD-guided placement (EGDP). We aimed to compare EMP and EGDP in outpatients, ward patients, and critically ill patients with normal upper GI anatomy. METHODS: In 3 centers with no prior experience in EMP, patients were randomized to placement of a single-lumen nasoduodenal feeding tube either with EGDP or EMP. The primary endpoint was post-pyloric position of the tube on abdominal radiography. Patients were followed for 10 days to assess patency and adverse events. The analyses were performed according to the intention-to-treat principle. RESULTS: In total, 160 patients were randomized toEGDP (N = 76) or EMP (N = 84). Three patients withdrew informed consent, and no abdominal radiography was performed in 2 patients. Thus, 155 patients (59 intensive care unit, 38%) were included in the analyses. Rates of post-pyloric tube position between EGDP and EMP were comparable (79% vs 82%, odds ratio 1.16; 90% confidence interval, 0.58-2.38; P = .72). Adverse events were observed in 4 patients after EMP (hypoxia, GI blood loss, atrial fibrillation, abdominal pain) and in 4 after EGDP (epistaxis N = 2, GI blood loss, hypoxia). Costs of tube placements were lower for EMP compared with EGDP: $519.09 versus $622.49, respectively (P = .04). CONCLUSIONS:Success rates and safety of EMP and EGDP in patients with normal upper GI anatomy were comparable. Lower costs and potential logistic advantages may drive centers to adopt EMP as their new standard of care. (Clinical trial registration number: NTR4286.).
RCT Entities:
BACKGROUND AND AIMS: Electromagnetic-guided placement (EMP) of a nasoduodenal feeding tube by trained nurses is an attractive alternative to EGD-guided placement (EGDP). We aimed to compare EMP and EGDP in outpatients, ward patients, and critically illpatients with normal upper GI anatomy. METHODS: In 3 centers with no prior experience in EMP, patients were randomized to placement of a single-lumen nasoduodenal feeding tube either with EGDP or EMP. The primary endpoint was post-pyloric position of the tube on abdominal radiography. Patients were followed for 10 days to assess patency and adverse events. The analyses were performed according to the intention-to-treat principle. RESULTS: In total, 160 patients were randomized to EGDP (N = 76) or EMP (N = 84). Three patients withdrew informed consent, and no abdominal radiography was performed in 2 patients. Thus, 155 patients (59 intensive care unit, 38%) were included in the analyses. Rates of post-pyloric tube position between EGDP and EMP were comparable (79% vs 82%, odds ratio 1.16; 90% confidence interval, 0.58-2.38; P = .72). Adverse events were observed in 4 patients after EMP (hypoxia, GI blood loss, atrial fibrillation, abdominal pain) and in 4 after EGDP (epistaxis N = 2, GI blood loss, hypoxia). Costs of tube placements were lower for EMP compared with EGDP: $519.09 versus $622.49, respectively (P = .04). CONCLUSIONS: Success rates and safety of EMP and EGDP in patients with normal upper GI anatomy were comparable. Lower costs and potential logistic advantages may drive centers to adopt EMP as their new standard of care. (Clinical trial registration number: NTR4286.).
Authors: Fabio Catache Mancini; Diogo Turiani Hourneaux de Moura; Mateus Pereira Funari; Igor Braga Ribeiro; Fernando Lopes Ponte Neto; Pastor Joaquin Ortiz Mendieta; Thomas R McCarty; Wanderley Marques Bernardo; Sergio Carlos Nahas; Eduardo Guimarães Hourneaux de Moura Journal: Endosc Int Open Date: 2022-08-15