Department of Physical Medicine and Rehabilitation, Department of Anesthesiology and Critical Care Medicine.
Department of Physical Medicine and Rehabilitation, Hartford Healthcare-Hartford Hospital, Hartford, Connecticut.
Ann Am Thorac Soc. 2021 Oct;18(10):1693-1701. doi: 10.1513/AnnalsATS.202010-1282OC.
The feasibility of a large, multicenter, randomized controlled trial comparing the risks and benefits of early-use speaking valve after tracheostomy is not clear. To investigate the feasibility of accelerated (⩽24 h) versus standard (⩾48 h) one-way speaking valve ("speaking valve") placement after percutaneous tracheostomy. Twenty awake patients (Glasgow Coma Scale score ⩾9) were randomized to accelerated or standard timing of speaking valve placement. Outcomes included patient identification and recruitment, adherence to protocol-defined time windows for valve placement, experimental separation in time to first speaking valve placement between groups, effectiveness of speech and swallowing (Sentence Intelligibility Test score, patient-reported quality of life), and clinical outcomes (safety events, speaking valve tolerance, decannulation, length of stay, and mortality). Of 161 patients undergoing percutaneous tracheostomy, 20 of 36 meeting eligibility criteria were randomized. The median time to speaking valve placement was 22 (interquartile range [IQR], 21-23) hours in the accelerated arm versus 45.5 (IQR, 43-50) hours for the standard arm. No aspiration, hypoxemia, or other safety events occurred in either arm as a result of the speaking valve. Sentence intelligibility test scores were not different between arms but correlated with quality of life. After three sessions, patients in the accelerated arm tolerated longer speaking valve trials than those in the standard arm [median, 65 (IQR, 45-720) min vs. median, 15 (IQR, 3-20) min]. Seven patients in the accelerated arm were decannulated before hospital discharge versus one patient in the standard arm. Speaking valve placement within 24 hours of percutaneous tracheostomy is feasible. A multicenter randomized controlled trial should be conducted to evaluate the safety of this strategy and compare important clinical outcomes, including time to speech and swallow recovery after tracheostomy.Clinical trial registered with ClinicalTrials.gov (NCT03008174).
经皮气管切开术后早期（≤24 小时）与标准（≥48 小时）使用单向说话阀的风险和获益比较的大样本、多中心、随机对照试验的可行性尚不清楚。本研究旨在探讨经皮气管切开术后加速（≤24 小时）与标准（≥48 小时）放置单向说话阀的可行性。20 例清醒（格拉斯哥昏迷评分≥9 分）患者随机分为加速组或标准组，分别在气管切开术后≤24 小时和≥48 小时使用说话阀。主要结局包括患者识别和招募、遵循试验规定的说话阀放置时间窗、两组之间首次使用说话阀时间的实验性分离、言语和吞咽功能（句子可懂度测试评分、患者报告的生活质量）以及临床结局（安全性事件、说话阀耐受情况、拔管、住院时间和死亡率）。在 161 例行经皮气管切开术的患者中，符合纳入标准的 36 例患者中有 20 例被随机分组。加速组中位说话阀使用时间为 22（四分位距，21-23）小时，标准组为 45.5（四分位距，43-50）小时。两组均无因使用说话阀导致的误吸、低氧血症或其他安全性事件。两组句子可懂度测试评分无差异，但与生活质量相关。在 3 次治疗后，加速组患者耐受说话阀试验时间长于标准组[中位数，65（四分位距，45-720）min 比中位数，15（四分位距，3-20）min]。加速组有 7 例患者在出院前拔管，标准组仅 1 例。经皮气管切开术后 24 小时内放置说话阀是可行的。应开展多中心随机对照试验，以评估该策略的安全性，并比较重要的临床结局，包括气管切开术后言语和吞咽功能恢复时间。临床试验注册于 ClinicalTrials.gov（NCT03008174）。
