Departments of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA.
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Lancet Respir Med. 2019 May;7(5):447-455. doi: 10.1016/S2213-2600(18)30421-1. Epub 2019 Feb 13.
In patients with non-expandable lung, removal of pleural fluid can result in excessively negative pleural pressure, which is associated with chest discomfort, pneumothorax, and re-expansion pulmonary oedema. Pleural manometry is widely used to safeguard against pressure-related complications during thoracentesis despite little evidence to support the approach. We investigated whether monitoring of pleural pressure with manometry during thoracentesis could protect against complications compared with assessment of symptoms alone.
We did a prospective randomised single-blind trial involving patients with large pleural effusions at two academic medical centres in, Nashville, TN, and Baltimore, MD, USA. Eligible patients were adults with free-flowing effusions estimated to be at least 0·5 L who could remain seated throughout the procedure. Patients were randomly assigned 1:1 to receive thoracentesis guided by symptoms only (control) or by symptoms plus manometry at timepoints based on volume drained. The randomisation schedule was computer generated, used permuted blocks of four and six, and was stratified by participating institution. Patients, who were masked to study-group assignment, were asked to rate chest discomfort on 100 mm visual analogue scales before, during, and after drainage. In both groups drainage was discontinued before complete evacuation of pleural fluid if patients developed persistent chest discomfort, intractable cough, or other complications. In the manometry group, an additional criterion for stopping was if end-expiratory pleural pressure was lower than -20 cm HO or declined by more than 10 cm HO between two measurements to a value less than or equal to -10 cm HO. The primary outcome was overall chest discomfort from before the start to after the procedure measured by patients 5 min after the end of drainage. Analysis was by modified intention to treat (ie, included all patients with any procedure or outcome data). This trial is registered with ClinicalTrials.gov, number NCT02677883.
Between March 4, 2016, and Sept 8, 2017, 191 patients were screened, of whom 128 were randomly assigned treatment and 124 were included in the final analysis (62 in each group). Four patients were excluded because of manometer malfunction (n=2), inability to access effusion due to pleural tumour burden (n=1), and inability to remain seated (n=1). Groups did not differ for the primary outcome (mean difference in chest discomfort score 2·4 mm, 95% CI -5·7 to 10·5, p=0·56). Six (10%) of 62 patients in the control group had asymptomatic pneumothorax ex vacuo compared with none in the manometry group (p=0·01). No serious complications occurred in either group.
Measurement of pleural pressure by manometry during large-volume thoracentesis does not alter procedure-related chest discomfort. Our findings do not support the routine use of this approach.
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在非可扩张性肺部的患者中，清除胸腔积液可能导致过度的胸腔负压，这与胸痛、气胸和复张性肺水肿有关。尽管几乎没有证据支持这种方法，但胸膜测压广泛用于在胸腔穿刺术期间防止与压力相关的并发症。我们研究了在胸腔穿刺术期间使用胸膜测压监测胸膜压力是否可以预防并发症，与仅评估症状相比。
我们在田纳西州纳什维尔和马里兰州巴尔的摩的两个学术医疗中心进行了一项前瞻性随机单盲试验，涉及大量胸腔积液的患者。有资格的患者是估计至少有 0.5 L 自由流动积液的成年患者，可以在整个过程中保持坐姿。患者以 1:1 的比例随机分配接受仅根据症状（对照组）或根据症状和根据排出量进行的胸膜测压指导的胸腔穿刺术。随机方案是计算机生成的，使用了四和六的置换块，并按参与机构进行了分层。患者对研究组分配不知情，并在引流前后使用 100 毫米视觉模拟量表评估胸痛。在两组中，如果患者出现持续胸痛、难治性咳嗽或其他并发症，在完全排空胸腔积液之前，引流就会停止。在测压组中，如果呼气末胸膜压力低于-20 cmHO 或两次测量之间下降超过 10 cmHO 至低于或等于-10 cmHO，则停止引流的另一个标准。主要结局是患者在引流结束后 5 分钟测量的从开始到结束过程中的整体胸痛。分析采用改良意向治疗（即包括所有有任何程序或结局数据的患者）。该试验在 ClinicalTrials.gov 注册，编号为 NCT02677883。
在 2016 年 3 月 4 日至 2017 年 9 月 8 日期间，对 191 名患者进行了筛选，其中 128 名被随机分配接受治疗，124 名患者被纳入最终分析（每组 62 名）。由于测压计故障（n=2）、胸腔肿瘤负荷导致无法进入积液（n=1）和无法保持坐姿（n=1），有 4 名患者被排除在外。两组在主要结局方面没有差异（胸痛评分平均差异 2.4 毫米，95%CI-5.7 至 10.5，p=0.56）。与测压组相比，对照组中有 6（10%）名 62 名无症状气胸患者出现单纯性气胸（p=0.01）。两组均未发生严重并发症。
在大容量胸腔穿刺术期间通过测压测量胸膜压力不会改变与程序相关的胸痛。我们的研究结果不支持常规使用这种方法。
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