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Promotion of Regular Oesophageal Motility to Prevent Regurgitation and Enhance Nutrition Intake in Long-Stay ICU Patients. A Multicenter, Phase II, Sham-Controlled, Randomized Trial: The PROPEL Study.

促进规律的食管动力,防止返流,增强 ICU 长期住院患者的营养摄入。一项多中心、 II 期、假对照、随机试验: 推进研究。

  • 影响因子:3.31
  • DOI:10.1097/CCM.0000000000004176
  • 作者列表:"Heyland DK","Marquis F","Lamontagne F","Albert M","Turgeon AF","Khwaja KA","Garland A","Hall R","Chapman MG","Kutsiogannis DJ","Martin C","Sessler DI","Day AG
  • 发表时间:2020-01-06
Abstract

OBJECTIVES:To evaluate the effect of esophageal stimulation on nutritional adequacy in critically ill patients at risk for enteral feeding intolerance. DESIGN:A multicenter randomized sham-controlled clinical trial. SETTING:Twelve ICUs in Canada. PATIENTS:We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently. INTERVENTIONS:Patients were randomly assigned 1:1 to esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment. All patients were fed via these catheters using a standardized feeding protocol. MEASUREMENTS AND MAIN RESULTS:The co-primary outcomes were proportion of caloric and protein prescription received enterally over the initial 7 days following randomization. Among 159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group. Over the 7-day study period, the percent of prescribed caloric intake (± SE) received by the enteral route was 64% ± 2 in the active group and 65% ± 2 in sham patients for calories (difference, -1; 95% CI, -8 to 6; p = 0.74). For protein, it was 57% ± 3 in the active group and 60% ± 3 in the sham group (difference, -3; 95% CI, -10 to 3; p = 0.30). Compared to the sham group, there were more serious adverse events reported in the active treatment group (13 vs 6; p = 0.053). Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006). CONCLUSIONS:Esophageal stimulation via a special feeding catheter did not improve nutritional adequacy and was associated with increase risk of harm in critically ill patients.

摘要

目的: 评价食管刺激对有肠内喂养不耐受风险的危重患者营养充分性的影响。 设计: 多中心随机假对照临床试验。 地点: 加拿大的 12 个 icu。 患者: 我们纳入了机械通气的 ICU 患者,这些患者给予中等至高剂量的阿片类药物,并预计在 48 小时内保持存活和通气,并且接受肠内营养或预计立即开始。。 干预措施: 1:1 通过食管刺激导管 (E-Motion 管; E-Motion Medical,以色列特拉维夫) 或假治疗将患者随机分配至食管刺激。所有患者均使用标准化喂养方案通过这些导管进行喂养。 测量和主要结果: 共同主要结局为随机分组后最初 7 天肠道接受的热量和蛋白质处方比例。在随机分组的 159 例患者中,改良意向治疗分析包括 155 例患者: 积极治疗组 73 例,假治疗组 82 例。在 7 天的研究期间,规定热量摄入的百分比 (± SE) 通过肠内途径接受的卡路里在活动组为 64% ± 2,在假病人为 65% ± 2 (差异,-1; 95% CI,-8 ~ 6; p = 0.74)。对于蛋白,活性组为 57% ± 3,假手术组为 60% ± 3 (差异,-3; 95% CI,-10-3; p = 0.30)。与假手术组相比,积极治疗组报告的严重不良事件更多 (13 vs 6; p = 0.053)。通过动态心电图监测,活动组 70 例中有 36 例 (51%) 检测到临床重要心律失常,而假手术组 76 例中有 22 例 (29%) 检测到临床重要心律失常 (p = 0.006)。 结论: 通过特殊喂养导管的食管刺激不能改善营养充分性,并与危重患者的伤害风险增加相关。

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相关文献
影响因子:3.31
发表时间:2020-01-06
来源期刊:Critical care medicine
DOI:10.1097/CCM.0000000000004176
作者列表:["Heyland DK","Marquis F","Lamontagne F","Albert M","Turgeon AF","Khwaja KA","Garland A","Hall R","Chapman MG","Kutsiogannis DJ","Martin C","Sessler DI","Day AG"]

METHODS:OBJECTIVES:To evaluate the effect of esophageal stimulation on nutritional adequacy in critically ill patients at risk for enteral feeding intolerance. DESIGN:A multicenter randomized sham-controlled clinical trial. SETTING:Twelve ICUs in Canada. PATIENTS:We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently. INTERVENTIONS:Patients were randomly assigned 1:1 to esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment. All patients were fed via these catheters using a standardized feeding protocol. MEASUREMENTS AND MAIN RESULTS:The co-primary outcomes were proportion of caloric and protein prescription received enterally over the initial 7 days following randomization. Among 159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group. Over the 7-day study period, the percent of prescribed caloric intake (± SE) received by the enteral route was 64% ± 2 in the active group and 65% ± 2 in sham patients for calories (difference, -1; 95% CI, -8 to 6; p = 0.74). For protein, it was 57% ± 3 in the active group and 60% ± 3 in the sham group (difference, -3; 95% CI, -10 to 3; p = 0.30). Compared to the sham group, there were more serious adverse events reported in the active treatment group (13 vs 6; p = 0.053). Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006). CONCLUSIONS:Esophageal stimulation via a special feeding catheter did not improve nutritional adequacy and was associated with increase risk of harm in critically ill patients.

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翻译标题与摘要 下载文献
影响因子:5.24
发表时间:2020-01-06
DOI:10.1164/rccm.201909-1810OC
作者列表:["Deane AM","Little L","Bellomo R","Chapman MJ","Davies AR","Ferrie S","Horowitz M","Hurford S","Lange K","Litton E","Mackle D","O'Connor S","Parker J","Peake SL","Presneill JJ","Ridley EJ","Singh V","van Haren F","Williams P","Young P","Iwashyna TJ","TARGET Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group."]

METHODS:RATIONALE:The long-term effects of delivering approximately 100% of recommended calorie intake via the enteral route during critical illness compared to a lesser amount of calories are unknown. OBJECTIVES:Our hypotheses were that achieving approximately 100% of recommended calorie intake during critical illness would increase quality of life scores, return to work and key life activities and reduce death and disability six months later. METHODS:We conducted a multicenter, blinded, parallel group, randomized clinical trial, with 3957 mechanically ventilated critically ill adults allocated to energy-dense (1.5 kcal/ml) or routine (1.0 kcal/ml) enteral nutrition. MEASUREMENTS AND MAIN RESULTS:Participants assigned energy-dense nutrition received more calories (% recommended energy intake, mean (SD) (energy-dense: 103% (28) vs. usual: 69% (18)). Mortality at day-180 was similar (560/1895 (29.6%) vs. 539/1920 (28.1%); relative risk 1.05 (95%CI, 0.95 to 1.16)). At a median [IQR] of 185 [182, 193] days after randomization, 2492 survivors were surveyed and reported similar quality of life (EuroQol five dimensions five-level quality of life questionnaire visual analogue scale, median [IQR]: 75 [60-85]; group difference: 0 (95%CI, 0 to 0)). Similar numbers of participants returned to work with no difference in hours worked or effectiveness at work (n=818). There was no observed difference in disability (n=1208) or participation in key life activities (n=705). CONCLUSIONS:The delivery of approximately 100% compared to 70% of recommended calorie intake during critical illness does not improve quality of life, or functional outcomes, or increase the number of survivors six months later. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02306746.

翻译标题与摘要 下载文献
影响因子:1.21
发表时间:2020-01-07
DOI:10.1097/SLE.0000000000000754
作者列表:["Tan JH","Sivadurai G","Tan HCL","Tan YR","Jahit S","Hans Alexander M"]

METHODS:BACKGROUND:Provision of enteral nutrition with jejunal feeding in upper gastrointestinal obstruction is highly recommended. Access to jejunum can be obtained surgically, percutaneously, or endoscopically. Our institution routinely and preferentially utilizes a silicone nasojejunal tube that is inserted past the obstruction endoscopically. We use a custom dual channel tube that allows feeding at the distal tip and another channel 40 cm from the tip that enables decompression proximally. This is a report of our experience with this custom nasojejunal tube. METHODS:This is a prospective observational study of 201 patients who underwent endoscopic nasojejunal wire-guided feeding tube insertions for obstruction of either the esophagus or the stomach including both benign and malignant pathologies between January 2015 to June 2018 in Hospital Sungai Buloh and Hospital Sultanah Aminah, Malaysia. The indications for tube insertion, insertion technique, and tube-related problems were described. RESULTS:The nasojejunal tube was used to establish enteral feeding in patients with obstructing tumors of the distal esophagus in 65 patients (32.3%) and gastric outlet obstruction in 72 patients (35.8%). There were 54 patients (26.9%) who required reinsertion. The most common reason for reinsertion was unintentional dislodgement, where 32 patients (15.9%) followed by tube blockage 20 patients (10.0%). Using our method of advancement under direct vision, we had only 2 cases of malposition due to severely deformed anatomy. We had no incidence of aspiration in this group of patients and overall, the patients tolerated the tube well. CONCLUSIONS:The novel nasojejunal feeding tube with gastric decompression function is a safe and effective method of delivery of enteral nutrition in patients with upper gastrointestinal obstruction. These tubes if inserted properly are well tolerated with almost no risk of malposition and are tolerated well even for prolonged periods of time until definitive surgery could be performed.

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