Erythromycin versus metoclopramide for post-pyloric spiral nasoenteric tube placement: a randomized non-inferiority trial |
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| Authors: | Bei Hu Xin Ouyang Liming Lei Cheng Sun Ruibin Chi Jian Guo Wenlong Guo Yanlin Zhang Yong Li Daoyong Huang Huafeng Sun Zhiqiang Nie Jieyang Yu Yuan Zhou Hao Wang Jinhe Zhang Chunbo Chen |
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| Institution: | 1.Department of Intensive Care Unit of Cardiovascular Surgery, Guangdong Cardiovascular Institute, Guangdong General Hospital,Guangdong Academy of Medical Sciences,Guangzhou,China;2.Guangdong General Hospital,School of Medicine, South China University of Technology,Guangzhou,China;3.Department of Critical Care Medicine, Guangdong General Hospital,Guangdong Academy of Medical Sciences,Guangzhou,China;4.Department of Critical Care Medicine,Xiaolan People’s Hospital of Zhongshan,Zhongshan,China;5.Department of Intensive Care Unit,People’s Hospital of Baise,Baise,China;6.Department of Surgical Intensive Care Unit,The First Affiliated Hospital of Hunan Traditional Chinese Medical College,Zhuzhou,China;7.Department of Critical Care Medicine,Xinjiang Kashgar First People’s Hospital,Kashgar,China;8.Department of Emergency,Cangzhou Central Hospital,Cangzhou,China;9.Department of Intensive Care Unit,Yangjiang City People’s Hospital,Yangjiang,China;10.Department of Intensive Care Unit,Chaozhou People’s Hospital,Chaozhou,China;11.Department of Epidemiology, Guangdong Cardiovascular Institute, Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangdong General Hospital,Guangdong Academy of Medical Sciences,Guangzhou,China |
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| Abstract: | PurposeTo determine whether erythromycin is non-inferior to metoclopramide in facilitating post-pyloric placement of self-propelled spiral nasoenteric tubes (NETs) in critically ill patients.MethodsA 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).ResultsA 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.ConclusionsErythromycin 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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