Department of Intensive Care Medicine, Amsterdam University Medical Centers, location VUmc, Postbox 7505, 1007 MB, Amsterdam, The Netherlands.
Amsterdam Cardiovascular Sciences Research Institute, Amsterdam UMC, Amsterdam, The Netherlands.
Crit Care. 2020 Oct 30;24(1):628. doi: 10.1186/s13054-020-03352-0.
Expiratory muscle weakness leads to difficult ventilator weaning. Maintaining their activity with functional electrical stimulation (FES) may improve outcome. We studied feasibility of breath-synchronized expiratory population muscle FES in a mixed ICU population ("Holland study") and pooled data with our previous work ("Australian study") to estimate potential clinical effects in a larger group.
Holland: Patients with a contractile response to FES received active or sham expiratory muscle FES (30 min, twice daily, 5 days/week until weaned). Main endpoints were feasibility (e.g., patient recruitment, treatment compliance, stimulation intensity) and safety. Pooled: Data on respiratory muscle thickness and ventilation duration from the Holland and Australian studies were combined (N = 40) in order to estimate potential effect size. Plasma cytokines (day 0, 3) were analyzed to study the effects of FES on systemic inflammation.
Holland: A total of 272 sessions were performed (active/sham: 169/103) in 20 patients (N = active/sham: 10/10) with a total treatment compliance rate of 91.1%. No FES-related serious adverse events were reported. Pooled: On day 3, there was a between-group difference (N = active/sham: 7/12) in total abdominal expiratory muscle thickness favoring the active group [treatment difference (95% confidence interval); 2.25 (0.34, 4.16) mm, P = 0.02] but not on day 5. Plasma cytokine levels indicated that early FES did not induce systemic inflammation. Using a survival analysis approach for the total study population, median ventilation duration and ICU length of stay were 10 versus 52 (P = 0.07), and 12 versus 54 (P = 0.03) days for the active versus sham group. Median ventilation duration of patients that were successfully extubated was 8.5 [5.6-12.2] versus 10.5 [5.3-25.6] days (P = 0.60) for the active (N = 16) versus sham (N = 10) group, and median ICU length of stay was 10.5 [8.0-14.5] versus 14.0 [9.0-19.5] days (P = 0.36) for those active (N = 16) versus sham (N = 8) patients that were extubated and discharged alive from the ICU. During ICU stay, 3/20 patients died in the active group versus 8/20 in the sham group (P = 0.16).
Expiratory muscle FES is feasible in selected ICU patients and might be a promising technique within a respiratory muscle-protective ventilation strategy. The next step is to study the effects on weaning and ventilator liberation outcome.
ClinicalTrials.gov, ID NCT03453944. Registered 05 March 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03453944 .
呼气肌无力会导致呼吸机撤离困难。使用功能性电刺激（FES）保持其活动能力可能会改善结果。我们研究了混合 ICU 人群中呼吸同步呼气群肌 FES 的可行性（“荷兰研究”），并将我们之前的工作（“澳大利亚研究”）的数据进行了汇总，以估计更大人群的潜在临床效果。
荷兰：对 FES 有收缩反应的患者接受主动或假刺激呼气肌 FES（30 分钟，每天 2 次，每周 5 天，直至撤离）。主要终点是可行性（例如，患者招募、治疗依从性、刺激强度）和安全性。汇总：将荷兰和澳大利亚研究中呼吸肌厚度和通气持续时间的数据进行合并（N=40），以估计潜在的效果大小。分析血浆细胞因子（第 0、3 天），以研究 FES 对全身炎症的影响。
荷兰：共进行了 272 次治疗（主动/假刺激：169/103），共 20 名患者（N=主动/假刺激：10/10），治疗依从率为 91.1%。未报告与 FES 相关的严重不良事件。汇总：第 3 天，主动组的总腹部呼气肌厚度有组间差异（N=主动/假刺激：7/12），有利于主动组[治疗差异（95%置信区间）；2.25（0.34，4.16）mm，P=0.02]，但第 5 天无差异。血浆细胞因子水平表明，早期 FES 并未引起全身炎症。使用总研究人群的生存分析方法，主动组和假刺激组的中位通气持续时间和 ICU 住院时间分别为 10 天和 52 天（P=0.07），12 天和 54 天（P=0.03）。成功拔管的患者中，主动组的中位通气持续时间为 8.5 [5.6-12.2]天，假刺激组为 10.5 [5.3-25.6]天（P=0.60），主动组（N=16）和假刺激组（N=10）的中位 ICU 住院时间分别为 10.5 [8.0-14.5]天和 14.0 [9.0-19.5]天（P=0.36）。ICU 住院期间，主动组有 3/20 名患者死亡，假刺激组有 8/20 名患者死亡（P=0.16）。
呼气肌 FES 在选定的 ICU 患者中是可行的，并且可能是一种有前途的呼吸肌保护通气策略。下一步是研究对撤机和呼吸机撤离结局的影响。
ClinicalTrials.gov，ID NCT03453944。2018 年 3 月 5 日注册-回顾性注册，https://clinicaltrials.gov/ct2/show/NCT03453944。
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