Academic Respiratory Unit, University of Bristol, Level 2, Learning & Research Building, Southmead Hospital, Bristol, BS10 5NB, UK.
North Bristol NHS Trust, Bristol, UK.
BMC Pulm Med. 2022 Aug 30;22(1):330. doi: 10.1186/s12890-022-02126-4.
Pleural infection is a complex condition with a considerable healthcare burden. The average hospital stay for pleural infection is 14 days. Current standard of care defaults to chest tube insertion and intravenous antibiotics. There have been no randomised trials on the use of therapeutic thoracentesis (TT) for pleural fluid drainage in pleural infection.
To assess the feasibility of a full-scale trial of chest tube vs TT for pleural infection in a single UK centre. The primary outcome was defined as the acceptability of randomisation to patients.
Adult patients admitted with a pleural effusion felt to be related to infection and meeting criteria for drainage (based on international guidelines) were eligible for randomisation. Participants were randomised (1:1) to chest tube insertion or TT with daily review assessing need for further drainages or other therapies. Neither participant nor clinician were blinded to treatment allocation. Patients were followed up at 90 days post-randomisation.
From September 2019 to June 2021, 51 patients were diagnosed with pleural infection (complex parapneumonic effusion/empyema). Eleven patients met the inclusion criteria for trial and 10 patients were randomised (91%). The COVID-19 pandemic had a substantial impact on recruitment. Data completeness was high in both groups with no protocol deviations. Patients randomised to TT had a significantly shorter overall mean hospital stay (5.4 days, SD 5.1) compared to the chest tube control group (13 days, SD 6.0), p = 0.04. Total number of pleural procedures required per patient were similar, 1.2 in chest tube group and 1.4 in TT group. No patient required a surgical referral. Adverse events were similar between the groups with no readmissions related to pleural infection.
The ACTion trial met its pre-specified feasibility criteria for patient acceptability but other issues around feasibility of a full-scale trial remain. From the results available the hypothesis that TT can reduce length of stay in pleural infection should be explored further.
ISRCTN: 84674413.
胸膜感染是一种复杂的疾病，会给医疗保健带来很大的负担。胸膜感染患者的平均住院时间为 14 天。目前的标准治疗方法是插入胸腔引流管和静脉使用抗生素。对于胸膜感染患者的胸腔积液引流，尚无关于治疗性胸腔穿刺术（TT）的随机试验。
评估在英国的一家单一中心进行胸腔引流管与 TT 治疗胸膜感染的全规模试验的可行性。主要结局定义为患者对随机分组的可接受性。
符合引流标准（基于国际指南）的因胸腔积液而入院的成年患者，认为与感染有关，符合随机分组条件。参与者被随机分为（1:1）胸腔引流管插入组或 TT 组，每天进行评估，以确定是否需要进一步引流或其他治疗。参与者和临床医生均未对治疗分配进行盲法。患者在随机分组后 90 天进行随访。
从 2019 年 9 月至 2021 年 6 月，51 名患者被诊断为胸膜感染（复杂性类肺炎性胸腔积液/脓胸）。11 名患者符合试验纳入标准，10 名患者被随机分组（91%）。COVID-19 大流行对招募工作产生了重大影响。两组的数据完整性均很高，无方案偏离。与胸腔引流管对照组（13 天，标准差 6.0）相比，TT 组患者的总平均住院时间（5.4 天，标准差 5.1）明显更短，p=0.04。每位患者所需的胸腔操作总数相似，胸腔引流管组为 1.2 次，TT 组为 1.4 次。无患者需要转外科治疗。两组的不良事件相似，无因胸膜感染再入院的病例。
ACTion 试验符合其预先指定的患者可接受性可行性标准，但全规模试验的其他可行性问题仍然存在。根据现有结果，TT 可缩短胸膜感染患者住院时间的假设应进一步探讨。
ISRCTN: 84674413。
