Every year, around 3,000 young people in the UK are admitted to hospital with a collapsed lung, and doctors want to know whether simply leaving them to heal on their own works better than the standard invasive treatments. The problem is that current guidelines for a large, symptomatic primary spontaneous pneumothorax (PSP) push for immediate drainage—either a needle aspiration or insertion of a chest drain, which usually requires a hospital stay. An Australasian trial recently suggested that conservative care (no invasive procedure) might be just as effective and could even reduce recurrence, but this approach is not routine in the NHS. The CONSEPT trial will randomise 638 patients across 35 hospitals in England, Scotland, and Wales to either conservative care or usual care (needle aspiration, chest drain, or pleural vent). The primary outcome is whether a patient needs any pleural procedure within 30 days. If conservative care proves superior, it could spare thousands of young people from unnecessary hospital admissions and invasive procedures each year, shifting emergency and respiratory guidelines toward a simpler, less costly first-line approach. The results will be published in a high-impact medical journal and shared with lung charities to ensure rapid translation into practice.
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Research Question Is initial conservative care of large symptomatic primary spontaneous pneumothorax (PSP) superior to initial usual invasive care in reducing risk of requiring a subsequent pleural intervention? Background Primary spontaneous Pneumothorax (PSP) typically affects young people, causing 3,000 admissions/year in the UK. Contemporary guidelines focus on treating a PSP either with short-term drainage (needle aspiration) or if this fails, with insertion of an intercostal chest drain (ICD), which typically requires admission. We have also shown that ambulatory treatment with a pleural vent is an effective treatment. There is evidence that not using an invasive pleural procedure may be a valid strategy. A recent Australasian trial compared conservative care to ICD insertion. The trial found that conservative care is effective in improving radiological outcomes and may reduce recurrence rates. Despite this evidence, optimal initial treatment remains contentious and conservative care is not routine within the NHS. Aims and objectives Aim: To evaluate whether conservative care for large symptomatic PSPs is superior to usual care. Objectives: a) To test whether conservative care is superior to usual care with respect to the need for a subsequent pleural procedure over the first 30 days. b) To estimate the difference between groups with respect to a range of patient-reported and clinical secondary outcomes over the first 30 days. c) To estimate the difference in recurrence rates between groups over 12 months follow-up. d) To estimate the cost-effectiveness of conservative care compared to usual care. Methods A multicentre, parallel, individually randomised controlled superiority trial in 35 hospitals in England, Scotland and Wales. 638 adult patients with PSP of sufficient size and symptoms causing the treating physician to consider intervention will be randomised between conservative care (intervention) or usual care (comparator). Usual care will consist of either needle aspiration, ICD or pleural vent. The primary outcome is any pleural procedure administered at any time after randomisation and after completion of initial care up to 30 days after randomisation (ICD insertion, needle aspiration, pleural vent, video-assisted thoracoscopy for persistent air-leak). Secondary outcomes are length of hospitalisation, pain and breathlessness scores, patient-related health status, radiological resolution, overall number of pleural procedures, PSP recurrence, acceptability, healthcare utilisation and costs, and cost-effectiveness. Timeline (months) 64-month project: Set-up (8 months); pilot recruitment (14 months); further recruitment (28 months); follow-up (minimum 6 months follow-up); study close-down analysis and reporting (8 months) Anticipated impact and dissemination The findings from this trial will impact on current care for PSP by determining the role of conservative care and will influence emergency and respiratory clinicians in managing a common respiratory presentation. Results will be submitted to major international meetings and for publication in a high impact medical journal. We anticipate rapid translation of results into clinical practice and incorporation in national and international guidelines. A plain English summary will be prepared and disseminated with the help of our PPI group and we will work with lung charities to generate other social media and internet summaries of the finding
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