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Erythromycin versus metoclopramide for post-pyloric spiral nasoenteric tube placement: a randomized non-inferiority trial.
Hu, B, Ouyang, X, Lei, L, Sun, C, Chi, R, Guo, J, Guo, W, Zhang, Y, Li, Y, Huang, D, et al
Intensive care medicine. 2018;(12):2174-2182
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Abstract
PURPOSE To determine whether erythromycin is non-inferior to metoclopramide in facilitating post-pyloric placement of self-propelled spiral nasoenteric tubes (NETs) in critically ill patients. METHODS A prospective, multicenter, open-label, parallel, and non-inferiority randomized controlled trial was conducted comparing erythromycin with metoclopramide in facilitating post-pyloric placement of spiral NETs in critically ill patients admitted to intensive care units (ICUs) of eight tertiary hospitals in China. The primary outcome was procedure success defined as post-pyloric placement (spiral NETs reached the first portion of the duodenum or beyond confirmed by abdominal radiography 24 h after tube insertion). RESULTS A total of 5688 patients were admitted to the ICUs. Of these, in 355 patients there was a plan to insert a nasoenteric feeding tube, of whom 332 were randomized, with 167 patients assigned to the erythromycin group and 165 patients assigned to the metoclopramide group. The success rate of post-pyloric placement was 57.5% (96/167) in the erythromycin group, as compared with 50.3% (83/165) in the metoclopramide group (a difference of 7.2%, 95% CI - 3.5% to 17.9%), in the intention-to-treat analysis, not including the prespecified margin of - 10% for non-inferiority. The success rates of post-D1 (reaching the second portion of the duodenum or beyond), post-D2 (reaching the third portion of the duodenum or beyond), post-D3 (reaching the fourth portion of the duodenum or beyond), and proximal jejunum placement and the incidence of any adverse events were not significantly different between the groups. CONCLUSIONS Erythromycin is non-inferior to metoclopramide in facilitating post-pyloric placement of spiral NETs in critically ill patients. The success rates of post-D1, post-D2, post-D3, and proximal jejunum placement were not significantly different.
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Electromagnetic-Guided Bedside Placement of Nasoenteral Feeding Tubes by Nurses Is Non-Inferior to Endoscopic Placement by Gastroenterologists: A Multicenter Randomized Controlled Trial.
Gerritsen, A, de Rooij, T, Dijkgraaf, MG, Busch, OR, Bergman, JJ, Ubbink, DT, van Duijvendijk, P, Erkelens, GW, Klos, M, Kruyt, PM, et al
The American journal of gastroenterology. 2016;(8):1123-32
Abstract
OBJECTIVES Electromagnetic (EM)-guided bedside placement of nasoenteral feeding tubes by nurses may improve efficiency and reduce patient discomfort and costs compared with endoscopic placement by gastroenterologists. However, evidence supporting this task shift from gastroenterologists to nurses is limited. We aimed to compare the effectiveness of EM-guided and endoscopic nasoenteral feeding tube placement. METHODS We performed a multicenter randomized controlled non-inferiority trial in 154 adult patients who required nasoenteral feeding and were admitted to gastrointestinal surgical wards in five Dutch hospitals. Patients were randomly assigned (1:1) to undergo EM-guided or endoscopic nasoenteral feeding tube placement. The primary end point was the need for reinsertion of the feeding tube (e.g., after failed initial placement or owing to tube-related complications) with a prespecified non-inferiority margin of 10%. RESULTS Reinsertion was required in 29 (36%) of the 80 patients in the EM-guided group and 31 (42%) of the 74 patients in the endoscopy group (absolute risk difference -6%, upper limit of one-sided 95% confidence interval 7%; P for non-inferiority=0.022). No differences were noted in success and complication rates. In the EM-guided group, there was a reduced time to start of feeding (424 vs. 535 min, P=0.001). Although the level of discomfort was higher in the EM-guided group (Visual Analog Scale (VAS) 3.9 vs. 2.0, P=0.009), EM-guided placement received higher recommendation scores (VAS 8.2 vs. 5.5, P=0.008). CONCLUSIONS EM-guided bedside placement of nasoenteral feeding tubes by nurses was non-inferior to endoscopic placement by gastroenterologists in surgical patients and may be considered the preferred technique for nasoenteral feeding tube placement.
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A randomised controlled feasibility and proof-of-concept trial in delayed gastric emptying when metoclopramide fails: We should revisit nasointestinal feeding versus dual prokinetic treatment: Achieving goal nutrition in critical illness and delayed gastric emptying: Trial of nasointestinal feeding versus nasogastric feeding plus prokinetics.
Taylor, SJ, Allan, K, McWilliam, H, Manara, A, Brown, J, Greenwood, R, Toher, D
Clinical nutrition ESPEN. 2016;:1-8
Abstract
BACKGROUND & AIMS Delayed gastric emptying (DGE) commonly limits the use of enteral nutrition (EN) and may increase ventilator-associated pneumonia. Nasointestinal feeding has not been tested against dual prokinetic treatment (Metoclopramide and Erythromycin) in DGE refractory to metoclopramide. This trial tests the feasibility of recruiting this 'treatment-failed' population and the proof of concept that nasointestinal (NI) feeding can increase the amount of feed tolerated (% goal) when compared to nasogastric (NG) feeding plus metoclopramide and erythromycin treatment. METHODS Eligible patients were those who were mechanically ventilated and over 20 years old, with delayed gastric emptying (DGE), defined as a gastric residual volume ≥250 ml or vomiting, and who failed to respond to first-line prokinetic treatment of 3 doses of 10 mg IV metoclopramide over 24 h. When assent was obtained, patients were randomised to receive immediate nasointestinal tube placement and feeding or nasogastric feeding plus metoclopramide and erythromycin (prokinetic) treatment. RESULTS Of 208 patients with DGE, 77 were eligible, 2 refused assent, 25 had contraindications to intervention, almost exclusively prokinetic treatment, and it was feasible to recruit 50. Compared to patients receiving prokinetics (n = 25) those randomised to nasointestinal feeding (n = 25) tolerated more of their feed goal over 5 days (87-95% vs 50-89%) and had a greater area under the curve (median [IQR] 432 [253-464]% vs 350 [213-381]%, p = 0.026) demonstrating proof of concept. However, nasointestinally fed patients also had a larger gastric loss (not feed) associated with the NI route but not with the fluid volume or energy delivered. CONCLUSIONS This is first study showing that in DGE refractory to metoclopramide NI feeding can increase the feed goal tolerated when compared to dual prokinetic treatment. Future studies should investigate the effect on clinical outcomes. EU CLINICAL TRIALS REGISTER EudraCT number: 2012-001374-29.
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Incidence of gastroesophageal reflux associated with percutaneous endoscopic gastrostomy contrast agent viscosity: a randomized controlled crossover trial.
Shimizu, A, Muramatsu, H, Kura, T, Sakata, T
European journal of clinical nutrition. 2016;(9):1057-61
Abstract
BACKGROUND/OBJECTIVES Semisolid formulae are increasingly used in Japan to reduce the risks of gastroesophageal reflux (GER) and aspiration pneumonia in patients undergoing percutaneous endoscopic gastrostomy (PEG). We compared the incidences of GER after the use of liquid or semisolid contrast agents during PEG. SUBJECTS/METHODS Patients who planned to undergo PEG were randomly assigned to the liquid-first (LF) group (liquid contrast agent on day 1 after PEG and a semisolid contrast agent on day 2) or the semisolid-first (SF) group (reversed order). A 200-ml agent bolus was administered via a PEG tube to the patient in the supine position. The upper gastrointestinal tract was radiologically examined from onset to 1 min after the end of administration. The incidences of GER were compared. We also evaluated the daily changes in GER incidence, effect of hiatal hernia severity and adverse events. RESULTS We analyzed the results of 66 patients (32, LF group; 34, SF group). The incidence of GER observed using only liquid contrast was 27% (18/66) and that using only semisolid was 11% (7/66) (P=0.028). There was no difference in the GER incidences between day 1 and day 2. In patients with severe, mild and no hiatal hernia, GER incidences in the liquid contrast agent were 80% (4/5), 61% (11/18) and 33% (13/43), respectively (P=0.031). GER incidence after using the semisolid contrast agent was lower in patients with no and mild hiatal hernia. The predominant adverse event was diarrhea; aspiration was not observed. CONCLUSIONS Semisolid contrast agents reduced the incidence of GER after PEG.
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Feeding in Oral Cancer Patients After Massive Ablative Surgery: Percutaneous Endoscopic Gastrostomy or Nasogastric Tube.
Tabrizi, R, Hosseinpour, S, Taghizadeh, F
The Journal of craniofacial surgery. 2016;(4):1010-1
Abstract
Feeding after ablative oral cancer surgery is a major concern in postoperative care phase. The aim of this study was to compare postoperative phase of healing in patients undergoing nasogastric tube insertion and percutaneous endoscopic gastrostomy. In this single randomized clinical trial, 40 patients were randomly allocated to 2 groups according to a randomized list: group one (20 patients) had nasogastric tube for 4 weeks and group two (20 patients) underwent percutaneous endoscopic gastrostomy for 4 weeks or more after the surgery. Occurrence of infection and wound dehiscence was assessed. Weight loss was defined as reduction in patients' weight at 4 weeks after the surgery compared with preoperation. Weight loss was 7.9 ± 1.91 kg in group one and 5.3 ± 1.38 kg in group two; the difference in this regard between the 2 groups was statistically significant (P = 0.001). In group one, 10 subjects had dehiscence versus 3 subjects in group two; this difference was significant (P = 0.04). Analysis of the data demonstrated a significant difference in postsurgical infection between the 2 groups (P = 0.044). It seems that gastrostomy may be an appropriate method for feeding in patients with extensive oral cancer.
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Rhubarb to Facilitate Placement of Nasojejunal Feeding Tubes in Patients in the Intensive Care Unit.
Li, J, Gu, Y, Zhou, R
Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition. 2016;(1):105-10
Abstract
BACKGROUND Prokinetic agents are sometimes needed to aid in the placement of nasojejunal feeding tubes in patients at risk of malnutrition. The objective of the present study was to evaluate the feasibility of rhubarb as a new prokinetic agent to replace metoclopramide and erythromycin in the placement of nasojejunal feeding tubes. MATERIALS AND METHODS Ninety-four patients who required jejunal feeding tube insertion were included. They were divided into rhubarb (n = 34), metoclopramide (n = 31), and erythromycin groups (n = 29), depending on the use of rhubarb, metoclopramide, and erythromycin as the prokinetic agent. The jejunal feeding tube insertions were performed at the bedside. An abdominal x-ray was taken as the gold standard to determine the position of the tube. Cases in which insertion failed in either group were subjected to a second insertion attempt using rhubarb as the prokinetic agent. RESULTS The success rates in the rhubarb, metoclopramide, and erythromycin groups were 91.2%, 87.1%, and 89.7%, respectively. The difference in the success rates was not statistically significant (P = .916). The insertion times in the rhubarb, metoclopramide, and erythromycin groups were 16.0 ± 1.9 minutes, 18.0 ± 1.9 minutes, and 18.8 ± 2.2 minutes, respectively. The insertion time in the rhubarb group was significantly shorter than those in metoclopramide and erythromycin groups (P < .001). No side effects were noted in the rhubarb group. CONCLUSIONS Rhubarb could serve as an effective prokinetic agent to promote the insertion of nasojejunal feeding tubes.
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Impact of nasogastric tubes on swallowing physiology in older, healthy subjects: A randomized controlled crossover trial.
Pryor, LN, Ward, EC, Cornwell, PL, O'Connor, SN, Finnis, ME, Chapman, MJ
Clinical nutrition (Edinburgh, Scotland). 2015;(4):572-8
Abstract
BACKGROUND & AIMS The presence of a nasogastric tube (NGT) affects swallowing physiology but not function in healthy young adults. The swallowing mechanism changes with increasing age, therefore the impact of a NGT on swallowing in elderly individuals is likely to be different but is not yet known. The aims of this study were to determine the effects of NGTs of different diameter on (1) airway penetration-aspiration, (2) pharyngeal residue, and (3) pharyngeal transit, in older healthy subjects. METHODS Randomized controlled crossover design. Healthy elderly volunteers underwent 3 modified barium swallow studies in which multiple diet and fluid consistencies were swallowed under the following conditions: (A) no NGT (control), (B) fine bore NGT, and (C) wide bore NGT. The control condition was assessed first to establish baseline swallowing function, then NGT order was randomly allocated. RESULTS Of the 15 volunteers (median age 65 years, range 60-81) complete data sets were obtained for 9 (4 with allocation order ABC; 5 with ACB). Wide bore NGT data could not be obtained for 6 volunteers mainly due to tube intolerance. The presence of a NGT was associated with: (i) an increase in airway penetration-aspiration (fine bore NGT with serial liquid swallows and puree) (p < 0.01); (ii) increased pharyngeal residue (p < 0.05) in the pyriform sinus (fine bore NGT with puree); and in the valleculae (both fine and wide bore NGT with soft solids); and (iii) an increase in pharyngeal transit duration regardless of consistency (p < 0.01), with longest swallowing durations with the widest tube. CONCLUSIONS NGT presence increases airway penetration-aspiration, pharyngeal residue and prolongs transit through the pharynx in older healthy individuals. Consideration of NGT impact on swallowing during concurrent oral and enteral feeding is recommended, with further systematic investigation required in elderly patients recovering from critical illness. Clinical trial registry Australia & New Zealand Clinical Trials Registry (ACTRN12613000577718).
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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, et al
Trials. 2015;:119
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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Randomized clinical trial: nasoenteric tube or jejunostomy as a route for nutrition after major upper gastrointestinal operations.
Torres Júnior, LG, de Vasconcellos Santos, FA, Correia, MI
World journal of surgery. 2014;(9):2241-6
Abstract
BACKGROUND Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality. In general, the patients are already malnourished, and early postoperative enteral nutrition is recommended. However, there is no consensus concerning the best enteral access route in these cases. METHODS A prospective randomized trial was performed from 2008 to 2012 with 59 patients who underwent esophagectomy, total gastrectomy, or pancreaticoduodenectomy. In all, 4 patients declined to participate, and 13 did not meet the inclusion criteria and were excluded. Of the 42 included patients, 21 had nasoenteric tubes, and 21 had a jejunostomy. RESULTS The two groups were similar in demographic and clinical aspects. The nasoenteric (NE) and jejunostomy groups underwent early enteral therapy in 71 and 62 % of cases (p > 0.05), respectively. The median length of enteral therapy use was less in the NE group (5.0 vs. 8.5 days), but the difference was not statistically significant. The NE group required introduction of parenteral therapy more frequently than the jejunostomy group (p < 0.05). Complications related to the enteral route occurred in 38.0 and 28.5 % of patients (p > 0.05) in the NE and jejunostomy groups, respectively. In the NE group, there were four losses and four tube obstructions. In the jejunostomy group, there were two losses, four obstructions, and two cases of leakage around the tube. In the latter group, patients who underwent therapy for a longer time had tubal complications (p < 0.05) and longer intensive care unit and hospital stays (p < 0.05). CONCLUSION The two enteral routes were associated with the same number of complications. However, the presence of a jejunostomy allowed enteral therapy for longer periods, especially in patients with complications, thus avoiding the need for parenteral nutrition.
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Intravenous fluids versus gastric-tube feeding in hospitalized infants with viral bronchiolitis: a randomized, prospective pilot study.
Kugelman, A, Raibin, K, Dabbah, H, Chistyakov, I, Srugo, I, Even, L, Bzezinsky, N, Riskin, A
The Journal of pediatrics. 2013;(3):640-642.e1
Abstract
The American Academy of Pediatrics recommends intravenous fluids for infants with bronchiolitis who are unable to sustain oral feedings. Our randomized, prospective pilot study shows that gastric tube feeding (in 31 infants) is feasible and demonstrated comparable clinical outcomes with intravenous fluids (in 20 infants) among hospitalized infants ≤6 months of age with moderate bronchiolitis.