Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial
Pharyngeal electrical stimulation for early decannulation in tracheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial
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DOI：
10.1016/s1474-4422(18)30255-2
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发表时间：
2018-10-01
期刊：
影响因子：
48
通讯作者：
Bath, Philip M.
中科院分区：
文献类型：
--
作者：
Dziewas, Rainer;Stellato, Rebecca;Bath, Philip M.
背景卒中后吞咽困难是常见的，尤其是在已经进行气管切开术的严重患者中。在一项初步试验中，咽部电刺激（PES）改善了这组患者的吞咽功能。我们的目的是复制和扩展这种单中心experience.Methods我们做了一个前瞻性的，单盲的，随机对照试验，在9个网站（7个急性护理医院，两个康复设施）在德国，奥地利和意大利。需要气管切开术的近期卒中患者被随机分配接受3天PES或假手术治疗（1：1）。所有患者均插入刺激导管;通过将PES基站连接到模拟器盒而不是导管来进行假治疗。通过计算机交互系统（按研究中心分层）进行随机化，每个研究中心4例患者。使用PES的患者和研究者未设盲。主要终点由每个研究中心的单独研究者评估，该研究者对治疗分配设盲。主要结局是治疗后24-72小时准备好拔管，使用吞咽的光纤内窥镜评估并基于标准化方案进行评估，包括没有大量唾液汇集，存在一次或多次自发吞咽，以及存在至少最小的喉感觉。我们计划对主要终点的优效性进行序贯统计分析。在获得50例患者（无效）、70例患者和此后每增加10例患者（最多140例患者）的主要结局数据后进行中期分析。研究结果从2015年5月29日至2017年7月5日，在81名患者中，来自9个研究中心的69名患者被随机分配接受PES（n=35）或假手术（n=34）治疗。至随机化的中位发作时间为28天（IQR 19-41; PES 28 [20-49];假手术28 [18-40]）。独立数据和安全监测委员会建议，在招募了70名患者并获得了69名患者的主要终点数据后，提前停止试验。这一决定得到了指导委员会的批准。PES组（35例患者中的17例[49%]）中准备好拔管的患者多于假手术组（34例患者中的3例[9%];比值比[OR] 7.00 [95% CI 2.41-19.88]; p=0.0008）。PES组24例（69%）患者和假手术组24例（71%）患者报告了不良事件。两组之间至少发生1起严重不良事件的患者数量无差异（PES组10例[29%]患者vs假手术组8例[23%]患者; OR 1.30 [0.44-3.83]; p=0.7851）。PES组7例（20%）患者和假手术组3例（9%）患者在研究期间死亡（OR 2.58 [0.61-10.97]; p=0.3059）。没有死亡或严重不良事件被判定为与PES.Interpretation在中风和随后的气管切开术的患者，PES增加了比例的患者准备拔管在这项研究中的人口，其中许多人收到PES在一个月内中风。未来的试验应确认PES是否对卒中后早期接受类似刺激的气管切开患者有益，并探索其在其他队列中的作用。版权所有（c）2018 Elsevier Ltd.保留所有权利。
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. Copyright (c) 2018 Elsevier Ltd. All rights reserved.