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

Background Primary Spontaneous Pneumothorax (PSP) 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. The Randomised Ambulatory Management of Primary Pneumothorax (RAMPP) trial, a multi-centre randomized controlled study, aimed to describe duration of hospitalisation and safety of ambulatory management compared to standard care (aspiration +/- standard chest tube insertion). Methods Over a period of 3 years, patients with PSP were recruited from 24 UK hospitals. Patients were randomly assigned to treatment with either an ambulatory device or standard guideline-based management. The primary outcome was total length of hospital stay including re-admission up to 30 days post-randomisation. Secondary outcomes were pain and breathlessness scores, need for further procedures, re-admission and recurrence rates. Findings The target recruitment of 236 patients was achieved. At 30 days, median hospitalisation was significantly shorter in those randomized to ambulatory treatment (median 0 days, IQR 0-3) compared with those who received standard care (median 4 days, IQR 0-8) (p<0.0001; median difference 2 days (95% CI 1-3)). Interpretation Ambulatory management of PSP significantly reduced duration of hospitalisation, including re-admissions in the first 30 days, but at the expense of increased adverse events. This data suggests PSP can be managed as an outpatient using ambulatory devices in those who require intervention.