| Objectives: Nasogastric feeding is the preferred way of feeding critically ill patients who are unable to have adequate oral intake,switching to post-pyloric feeding for patients at high risk for aspiration,with high gastric residual volumes or with intolerance of gastric feeding.Leveraging prokinetic agents to facilitating post-pyloric placement of self-propelled spiral nasoenteric tubes is a prospective strategy,which makes post-pyloric feeding initiated easier.The efficacy and safety of domperidone suspension for post-pyloric placement of spiral nasoenteric tubes have been demonstrated.However,the effect of simo decoction on the postpyloric placement of spiral nasoenteric tubes in critically ill patients remains unknown.Furthermore,debate continues regarding the best route of enteral nutrition and the true risks and benefits derived by the use of post-pyloric feeding over gastric feeding.And few studies focus on critically ill patients with acute gastrointestinal injury(AGI)grade Ⅱ whose route of enteral nutrition remains controversial.Therefore,the project aims to assess whether simo decoction is non-inferior to domperidone suspension in facilitating post-pyloric placement of spiral nasoenteric tubes in critically ill patients at first,and to explore the effect of post-pyloric feeding by spiral nasoenteric tubes on the prognosis in critically ill patients with AGI grade Ⅱ.Methods: Firstly,a prospective,multicenter,open-label and non-inferiority randomized controlled trial was performed with-10% as the non-inferiority margin.Patients were randomly assigned in a 1:1 ratio to receive simo decoction 20 m L q8 h,or domperidone suspension 20 m L q6 h for 24 hours.The primary outcome was procedure success defined as postpyloric placement.Secondly,a retrospective study with propensity score matching(PSM)was performed to analyze the clinical data of critically ill adult patients with AGI grade Ⅱ,who were enrolled in three randomized controlled trials conducted by Guangdong Provincial People’s Hospital(Guangdong Academy of Medical Sciences)for post-pyloric tube placement between April2012 to May 2019.Patients were divided into post-pyloric feeding group and gastric feeding group according to the tube tip position confirmed by abdominal X-ray 24 hours after tube insertion,and were PSM in a 1:1 ratio.The differences of each index between the two groups were compared before and after matching.Then logistic regression analyses were employed to explore the potential mortality risk factors of critically ill patients with AGI grade Ⅱ.Besides,subgroup analysis for ICU mortality in critically ill patients with AGI grade Ⅱ was conducted.Results: 224 patients were totally enrolled in the non-inferiority trial,and randomly assigned to the simo decoction group or the domperidone suspension group(n=112 per group).The success rate of post-pyloric placement was 41.1%(46/112)in the simo decoction group,as compared with 47.3%(53/112)in the domperidone suspension group [a risk difference of-6.3%,95% confidence internal(95% CI),-19.2% to 6.7%,adjusted risk difference-3.7%,95% CI-16.3% to 9.0%],in the intention-to-treat analysis,crossing the prespecified margin of-10% for non-inferiority.The P value of non-inferiority testing(one-sided μ-test)was more than 0.025.There were no differences between groups in the success rates of duodenal bulb or beyond,descending part of duodenum or beyond,horizontal part of duodenum or beyond and proximal jejunum placement,the incidences of any adverse events,length of ICU stay or mortality in ICU.A total of 215 critically ill patients with AGI grade Ⅱ were enrolled in the retrospective study,and there were both 90 patients in the post-pyloric feeding group and gastric feeding group after matching.Demographics and clinical characteristics of study population were well balanced between the two groups after matching.ICU mortality of critically ill patients with AGI grade Ⅱ and secondary AGI grade Ⅱ in post-pyloric feeding group were significantly lower than those in gastric feeding group(4.4% vs.15.6%,4.5% vs.15.9%,respectively,both P<0.05).Multivariate logistic regression analysis indicated that post-pyloric feeding was an independent protective factor [odds ratio(OR)0.295,95%CI 0.091 to 0.959,P=0.042] and APACHE Ⅱ score was an independent risk factor(OR 1.111,95%CI 1.025 to1.203,P=0.010)for ICU mortality in patients.And lower ICU mortality appeared on patients with APACHE Ⅱ score≥20 scores fed by post-pyloric route in the subgroup analysis(4.3% vs.23.7%,P<0.05).Conclusions: Non-inferiority of simo decoction to domperidone suspension was not confirmed in facilitating post-pyloric placement of spiral nasoenteric tubes.Post-pyloric feeding for critically ill patients with AGI grade Ⅱ could decrease ICU mortality and was an independent protective factor against mortality. |
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