Background

Primary spontaneous pneumothorax occurs in otherwise healthy young patients. Optimal management is not defined and often results in prolonged hospitalisation. Data on efficacy of ambulatory options are poor. We aimed to describe the duration of hospitalisation and safety of ambulatory management compared with standard care.

Methods

In this open-label, randomised controlled trial, adults (aged 16–55 years) with symptomatic primary spontaneous pneumothorax were recruited from 24 UK hospitals during a period of 3 years. Patients were randomly assigned (1:1) to treatment with either an ambulatory device or standard guideline-based management (aspiration, standard chest tube insertion, or both). The primary outcome was total length of hospital stay including re-admission up to 30 days after randomisation. Patients with available data were included in the primary analysis and all assigned patients were included in the safety analysis. The trial was prospectively registered with the International Standard Randomised Clinical Trials Number, ISRCTN79151659.

Findings

Of 776 patients screened between July, 2015, and March, 2019, 236 (30%) were randomly assigned to ambulatory care (n=117) and standard care (n=119). At day 30, the median hospitalisation was significantly shorter in the 114 patients with available data who received ambulatory treatment (0 days [IQR 0–3]) than in the 113 with available data who received standard care (4 days [IQR 0–8]; p<0·0001; median difference 2 days [95% CI 1–3]). 110 (47%) of 236 patients had adverse events, including 64 (55%) of 117 patients in the ambulatory care arm and 46 (39%) of 119 in the standard care arm. All 14 serious adverse events occurred in patients who received ambulatory care, eight (57%) of which were related to the intervention, including an enlarging pneumothorax, asymptomatic pulmonary oedema, and the device malfunctioning, leaking, or dislodging.

Interpretation

Ambulatory management of primary spontaneous pneumothorax significantly reduced the duration of hospitalisation including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests that primary spontaneous pneumothorax can be managed for outpatients, using ambulatory devices in those who require intervention.

Funding

UK National Institute for Health Research.

中文翻译：

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原发性自发性气胸的门诊治疗：一项开放标签、随机对照试验。

 背景

原发性自发性气胸发生在其他方面健康的年轻患者中。最佳管理尚无明确定义，通常会导致住院时间延长。关于门诊选择疗效的数据很差。我们的目的是描述与标准护理相比住院治疗的持续时间和门诊管理的安全性。

 方法

在这项开放标签、随机对照试验中，从 24 家英国医院招募了为期 3 年的有症状的原发性自发性气胸成人（年龄 16-55 岁）。患者被随机分配 (1:1) 接受门诊装置治疗或基于标准指南的治疗（抽吸、标准胸管插入或两者兼而有之）。主要结局是总住院时间，包括随机分组后 30 天的重新入院时间。具有可用数据的患者被纳入主要分析，所有分配的患者均被纳入安全性分析。该试验前瞻性地注册了国际标准随机临床试验编号 ISRCTN79151659。

 发现

在 2015 年 7 月至 2019 年 3 月期间筛查的 776 名患者中，236 名 (30%) 被随机分配到门诊护理 (n = 117) 和标准护理 (n = 119)。在第 30 天，根据现有数据，接受门诊治疗（0 天 [IQR 0–3]）的 114 名患者的住院时间中位数显着短于根据现有数据，接受标准护理（4 天 [IQR 0–8]）的 113 名患者。 ]；p<0·0001；中位差异 2 天 [95% CI 1-3]）。 236 名患者中有 110 名 (47%) 出现不良事件，其中门诊护理组 117 名患者中有 64 名 (55%) 发生不良事件，标准护理组 119 名患者中有 46 名 (39%) 发生不良事件。所有 14 例严重不良事件均发生在接受门诊护理的患者中，其中 8 例 (57%) 与干预有关，包括气胸扩大、无症状肺水肿以及装置故障、泄漏或移位。

 解释

原发性自发性气胸的门诊治疗显着缩短了住院时间，包括前 30 天的再次入院时间，但代价是不良事件增加。该数据表明，对于需要干预的患者，可以使用流动设备来管理门诊患者的原发性自发性气胸。

 资金

英国国家健康研究所。