经皮扩张气管切开术与单支一次性支气管镜和重复使用支气管镜的比较：一项前瞻性随机试验（TraSUB）。
Percutaneous dilatational tracheostomy with single use bronchoscopes versus reusable bronchoscopes - a prospective randomized trial (TraSUB).
机构信息
Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
出版信息
BMC Anesthesiol. 2022 Apr 2;22(1):90. doi: 10.1186/s12871-022-01618-4.
BACKGROUND
Apart from conventional reusable bronchoscopes, single-use bronchoscopes (SUB) were recently introduced. Data suggest that SUB might prevent from the risk of cross contamination (i.e. multiresistant pathogens, SARS CoV-2) and save costs. We aimed to investigate visualization, ventilation, handling characteristics, changes in patients' gas exchange, and costs associated with both types of bronchoscopes during percutaneous dilatational tracheostomy (PDT).
METHODS
In this prospective, randomized, noninferiority study, 46 patients undergoing PDT were randomized 1:1 to PDT with SUB (Ambu aScope) or reusable bronchoscopes (CONV, Olympus BF-P60). Visualization of tracheal structures rated on 4-point Likert scales was the primary end-point. Furthermore, quality of ventilation, device handling characteristics, changes in the patients' gas exchange, pH values, and costs were assessed.
RESULTS
Noninferiority for visualization (the primary endpoint) was demonstrated for the SUB group. Mean visualization scores (lower values better) were 4.1 (95% confidence intervals: 3.9;4.3) for SUB vs. 4.1 (4.0;4.2) for CONV. Noninferiority of ventilation (estimated by minute volume and SpO) during the procedure could be shown as well. Mean score was 2.6 (2.0;3.1) for SUB vs. 2.4 (2.1;2.7) for CONV (lower values better). No significant differences regarding handling (SUB: 1.2 (1.0;1.4), CONV: 1.3 (1.1;1.6)), blood gas analyses and respiratory variables were found. Cost analysis in our institution revealed 93 € per conventional bronchoscopy versus 232.50 € with SUB, not considering an estimate for possible infection due to cross-contamination with the reusable device.
CONCLUSION
In our study, visualization and overall performance of the SUB during PDT were noninferior to reusable bronchoscopes. Therefore, PDT with SUB is feasible and should be considered if favored by individual institution's cost analysis.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03952247 . Submitted for registration on 28/04/2019 and first posted on 16/05/2019.
背景
除了传统的可重复使用支气管镜外，最近还引入了一次性支气管镜（SUB）。有数据表明，SUB 可能会降低交叉污染（即多耐药病原体、SARS-CoV-2）的风险并节省成本。我们旨在研究经皮扩张气管切开术（PDT）中两种支气管镜的可视化、通气、操作特点、患者气体交换的变化以及相关成本。
方法
在这项前瞻性、随机、非劣效性研究中，46 名接受 PDT 的患者被随机分为 1:1 的 SUB 组（Ambu aScope）和可重复使用支气管镜组（CONV，Olympus BF-P60）。通过 4 分 Likert 量表评估气管结构的可视化程度是主要终点。此外，还评估了通气质量、设备操作特点、患者气体交换、pH 值和成本的变化。
结果
SUB 组在可视化（主要终点）方面表现出非劣效性。SUB 组的平均可视化评分（数值越低越好）为 4.1（95%置信区间：3.9；4.3），而 CONV 组为 4.1（4.0；4.2）。该程序中通气（通过分钟通气量和 SpO 估计）的非劣效性也得到了证明。SUB 组的平均评分为 2.6（2.0；3.1），而 CONV 组为 2.4（2.1；2.7）（数值越低越好）。在处理方面（SUB：1.2（1.0；1.4），CONV：1.3（1.1；1.6））、血气分析和呼吸变量方面未发现显著差异。我们机构的成本分析显示，每次常规支气管镜检查的费用为 93 欧元，而 SUB 的费用为 232.50 欧元，未考虑因与可重复使用设备交叉污染而可能导致的感染的估计费用。
结论
在我们的研究中，SUB 在 PDT 期间的可视化和整体性能与可重复使用的支气管镜非劣效。因此，如果考虑到机构成本分析的因素，如果个人机构青睐 SUB，则 PDT 可以考虑使用 SUB。
试验注册
ClinicalTrials.gov，NCT03952247。于 2019 年 4 月 28 日注册，于 2019 年 5 月 16 日首次发布。
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