Ambulatory management of primary spontaneous pneumothorax: an open-label, randomised controlled trial

Abstract

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.

Ambulatory management of primary spontaneous pneumothorax

“…Thus, the Randomised Ambulatory Management of Primary Pneumothorax (RAMPP) trial was devised [ 4 ]. The trial aimed to compare the length of hospitalisation and safety of ambulatory management with standard care (needle aspiration±ICD insertion) [ 5 ]. We aim to describe the outcomes of RAMPP.…”

Ambulatory Management of Primary Spontaneous Pneumothorax: The Jury Is Still Out

“…One such method is the use of a small valved device which can be left in place and allows the patient to remain ambulatory ( Figure 1). In a recent issue of The Lancet, Hallifax et al have published the results of randomized controlled trial comparing the ambulatory device with the standard care for primary spontaneous pneumothorax (PSP) [2]. Although the authors have concluded that ambulatory management of PSP is a reasonable and preferable option, there are few issues which need discussion.…”

Conservative management of primary spontaneous pneumothorax: A failed revolution?

“…The simple, easy-to-use material presently available should allow a minimally invasive strategy to be used for patients with a large PSP. Patients who can undergo rigorous surveillance could be eligible for ambulatory management after successful MA (10,18) or with the small-size CTD connected to a one-way valve (14,(19)(20)(21), provided that the patient's safety is assured. Further studies are still needed to define the optimal management of first-episode PSP patients.…”