A lung collapse in a patient with existing lung disease often leaves a stubborn air leak that keeps them in hospital for over a week, and doctors lack reliable evidence on which treatment works best. This matters because current care for secondary spontaneous pneumothorax (SSP) is a patchwork of invasive procedures—from simple observation to multiple surgical interventions—none backed by robust trials. Previous studies have been too small to produce clear answers. The researcher proposes a "platform trial," an innovative design that tests several treatments at once against a shared control group, requiring fewer patients and less time than traditional trials. Before launching such a trial, however, it must be shown that patients and clinicians will accept the approach. If this feasibility study succeeds, it will pave the way for a full-scale platform trial that could finally determine the best way to manage persistent air leaks. That would mean fewer days in hospital, fewer invasive procedures, and clearer treatment pathways for a frail, older population. The work uses NHS hospital data to define the patient group and includes interviews to understand why people agree—or refuse—to participate in such a trial.
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Secondary spontaneous pneumothorax (SSP) is a medical emergency in which the lung collapses in the presence of underlying lung disease. It occurs in older and co-morbid populations and patients experience a high symptom burden and typically remain in hospital for over a week. Current management includes inserting a chest tube through the chest wall to drain the air. Due to the underlying lung disease, the lung typically heals slowly and 90% of the time can take over 2 days to settle(1). This is referred to as persistent air leak (PAL). The current approaches for management of PAL range from simple observation, through to a variety of invasive techniques. Current management pathways are diverse, invasive and most importantly lacking in robust evidence. As a result of this, in practice, patients often undergo multiple interventions to resolve PAL. Previous treatment trials have been challenging, underpowered and inconclusive. Platform trials use innovative trial design to test multiple experimental therapies against a shared control group. Compared to traditional two arm randomised controlled trials (RCT), platform trials can require less resources, minimise the number of patients exposed to inferior interventions and can decrease the time to completion(5). Platform trials, however, represent a significant departure from traditional RCT design and to date no feasibility studies have been conducted to assess acceptability for patients and recruiting clinicians. Aims and objective: The overarching aim of this fellowship is 'to test the feasibility and acceptability of a platform trial in the management of patients with secondary spontaneous pneumothorax and persistent air leak' Specific objectives are to: Define the population of interest in year 1 of the fellowship. Explore the feasibility of an interventional platform design trial evaluating management strategies of PAL in patients with SSP by year 5. To conduct a qualitative sub-study to explore participant and clinician views of the platform study design by year 4. Methods: I will use Hospital Episode Statistics to define the population of interest, establish the prevalence of SSP and assess outcomes including mortality and length of stay. This information will aid design of the platform trial. A feasibility platform study will be conducted to assess the management of patients with SSP and PAL. It will address specific concerns regarding the feasibility and acceptability of a platform trial, mapping eligibility and recruitment pathways and will include the use of two-stage randomisation. An embedded qualitative sub-study will examine participants' and clinicians' experience of the interventions, trial process and factors influencing patient decisions to participate and accept randomisation or not. Timelines for delivery Total Fellowship duration is 60 months. Objectives 1, 2 and 3 will take 12, 48 and 24 months respectively and will run consecutively. Anticipated impact and dissemination If the initial study demonstrates the design to be feasible and acceptable in this patient population, I will apply for NIHR HTA funding stream by 2028. The full trial design will expand on all elements of the feasibility study. Results will be reported via a high-impact respiratory journal and international respiratory conferences.
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