Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial.
咽部电刺激用于中风后神经源性吞咽障碍气管切开患者的早期拔管 (PHAST-TRAC): 一项前瞻性、单盲、随机试验。

摘要

BACKGROUND:Dysphagia after stroke is common, especially in severely affected patients who have had a tracheotomy. In a pilot trial, pharyngeal electrical stimulation (PES) improved swallowing function in this group of patients. We aimed to replicate and extend this single-centre experience.
METHODS:We did a prospective, single-blind, randomised controlled trial across nine sites (seven acute care hospitals, two rehabilitation facilities) in Germany, Austria, and Italy. Patients with recent stroke who required tracheotomy were randomly assigned to receive 3 days of either PES or sham treatment (1:1). All patients had the stimulation catheter inserted; sham treatment was applied by connecting the PES base station to a simulator box instead of the catheter. Randomisation was done via a computerised interactive system (stratified by site) in blocks of four patients per site. Patients and investigators applying PES were not masked. The primary endpoint was assessed by a separate investigator at each site who was masked to treatment assignment. The primary outcome was readiness for decannulation 24-72 h after treatment, assessed using fibreoptic endoscopic evaluation of swallowing and based on a standardised protocol, including absence of massive pooling of saliva, presence of one or more spontaneous swallows, and presence of at least minimum laryngeal sensation. We planned a sequential statistical analysis of superiority for the primary endpoint. Interim analyses were to be done after primary outcome data were available for 50 patients (futility), 70 patients, and every additional ten patients thereafter, up to 140 patients. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN18137204.
FINDINGS:From May 29, 2015, to July 5, 2017, of 81 patients assessed, 69 patients from nine sites were randomly assigned to receive PES (n=35) or sham (n=34) treatment. Median onset to randomisation time was 28 days (IQR 19-41; PES 28 [20-49]; sham 28 [18-40]). The Independent Data and Safety Monitoring Board recommended that the trial was stopped early for efficacy after 70 patients had been recruited and primary endpoint data for 69 patients were available. This decision was approved by the steering committee. More patients were ready for decannulation in the PES group (17 [49%] of 35 patients) than in the sham group (three [9%] of 34 patients; odds ratio [OR] 7·00 [95% CI 2·41-19·88]; p=0·0008). Adverse events were reported in 24 (69%) patients in the PES group and 24 (71%) patients in the sham group. The number of patients with at least one serious adverse event did not differ between the groups (ten [29%] patients in the PES group vs eight [23%] patients in the sham group; OR 1·30 [0·44-3·83]; p=0·7851). Seven (20%) patients in the PES group and three (9%) patients in the sham group died during the study period (OR 2·58 [0·61-10·97]; p=0·3059). None of the deaths or serious adverse events were judged to be related to PES.
INTERPRETATION:In patients with stroke and subsequent tracheotomy, PES increased the proportion of patients who were ready for decannulation in this study population, many of whom received PES within a month of their stroke. Future trials should confirm whether PES is beneficial in tracheotomised patients who receive stimulation similarly early after stroke and explore its effects in other cohorts.
FUNDING:Phagenesis Ltd.

译文

背景: 中风后吞咽困难很常见,尤其是在接受过气管切开术的严重患者中。在一项初步试验中,咽电刺激 (PES) 改善了这组患者的吞咽功能。我们的目标是复制和扩展这种单中心体验。
方法: 我们在德国、奥地利和意大利的九个地点 (七个急症护理医院,两个康复机构) 进行了一项前瞻性、单盲、随机对照试验。需要气管切开术的近期中风患者被随机分配接受 3 天 PES 或假治疗 (1:1)。所有患者都插入了刺激导管; 通过将 PES 基站连接到模拟器盒而不是导管来实施假治疗。通过计算机交互系统 (按站点分层) 对每个站点的四名患者进行随机化。应用 PES 的患者和调查人员没有被掩盖。主要终点由每个部位的一名独立研究者进行评估,该研究者被掩盖在治疗分配上。主要结果是治疗后 24-72 小时的拔管准备就绪,使用纤维内窥镜评估吞咽,并基于标准化协议,包括没有大量唾液汇集, 存在一个或多个自发的燕子,并且存在至少最小的喉部感觉。我们计划对主要终点的优越性进行顺序统计分析。中期分析将在 50 名患者 (无效) 、 70 名患者以及此后每增加 10 名患者,多达 140 名患者的主要结局数据可用后进行。分析是通过意向治疗。本试验在 ISRCTN 注册中心注册,编号为 isrctn18137204。
结果: 从 2015年5月29日到 2017年7月5日,在被评估的 81 名患者中,来自 9 个部位的 69 名患者被随机分配接受 PES (n = 35) 或 sham (n = 34) 治疗。发病至随机时间的中位数为 28 天 (IQR 19-41; PES 28 [20-49]; sham 28 [18-40])。独立数据和安全监测委员会建议,在招募了 70 名患者并且获得了 69 名患者的主要终点数据后,为了疗效,该试验应尽早停止。指导委员会批准了这项决定。PES 组 (35 名患者中的 17 名 [49%]) 比假组 (34 名患者中的 3 名 [9%]) 有更多的患者准备进行拔管; 比值比 [OR] 7 · 00 [95% CI 2 · 41-19 · 88]; p = 0 · 0008)。PES 组 24 例 (69%) 患者和假组 24 例 (71%) 患者报告了不良事件。至少有一个严重不良事件的患者数量在两组之间没有差异 (PES 组的 10 名 [29%] 患者与假组的 8 名 [23%] 患者; 或 1 30 [0 44-3 83]; p = 0 7851)。PES 组的 7 名 (20%) 患者和假组的 3 名 (9%) 患者在研究期间死亡 (或 2 · 58 [0 · 61-10 · 97]; p = 0 3059)。没有死亡或严重不良事件被判定与 PES 有关。
解释: 在中风和随后的气管切开患者中,PES 增加了该研究人群中准备拔管的患者比例,其中许多人在中风后一个月内接受了 PES。未来的试验应该确认气管切开患者在中风后早期同样接受刺激是否有益,并在其他人群中探索其效果。
资金: Phagenesis 有限公司

dysphagia

消化 进食困难 疾病
概述  :  

吞咽障碍指由于下颌、双唇、舌、软腭、咽喉、食管、括约肌或食管功能受损,不能安全有效的把食物由口腔送到胃内从而获取足够营养和水分的进食困难。随着我国人口老龄化加速,衰老、退行性改变、脑卒中、咽部和喉部肿瘤术后等致吞咽功能障碍患者越来越多,神经系统疾病患吞咽障碍发生率为64%~78%,中国老年人吞咽障碍的总体患病率为38.7%,一般社区老年人群的吞咽障碍患病率为10.63%~13.9%,养护机构为26.4%~32.5%。吞咽障碍康复治疗与护理需要尽早进行,以促进患者康复并提高生活质量。 

dysphagia 英 /dɪs'feɪdʒɪə/  美 /dɪs'fedʒɪə/

释义   n. [医] 咽下困难,[医] 吞咽困难

例句   Objective: To observe the effect of systematized healthy education in the rehabilitation therapy with dysphagia.  目的:观察系统化健康教育在脑卒中吞咽困难患者康复中的效果。


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