Every year, more than 50,000 people in England and Wales are diagnosed with a traumatic collapsed lung, and roughly half receive a chest drain—a tube inserted between the ribs that carries a 15–30% risk of complications like bleeding or infection. This trial tackles a longstanding clinical dilemma: for many patients with a significant pneumothorax, doctors are unsure whether a chest drain is truly necessary. Without robust evidence, the default is often invasive treatment, which may cause avoidable harm. The study will randomise 750 patients across 25 hospitals to either conservative management (observation without a drain) or standard chest drain insertion, then track who needs an emergency pleural intervention within 30 days. If conservative management proves non-inferior—meaning the rate of subsequent emergency procedures is no more than 7.5% higher than with a chest drain—it could change emergency care overnight. Thousands of patients each year could avoid a painful, risky procedure, spend less time in hospital, and recover with fewer complications. The trial also includes an economic analysis to show whether the approach saves the NHS money, and a qualitative study to assess whether patients and clinicians find it acceptable. Results will be fed directly into national guidelines from NICE and the British Thoracic Society.
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Research Question Is initial conservative management of significant traumatic pneumothoraces non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness, and quality of life? Background Traumatic pneumothoraces (collapsed lung) occur in 1 in 5 victims of trauma. In 2019 >50,000 patients were diagnosed with traumatic pneumothoraces in England and Wales. Typically, half of these patients will be treated by insertion of a tube (or chest drain) into the chest. Chest drains carry a high-risk of complications (15-30%) such as bleeding and infection and there is no robust evidence to inform practice. Consequently, in many cases clinicians remain uncertain whether a chest drain is needed and a default to invasive treatment may cause avoidable patient harm. Aims and Objectives Aim: To establish whether initial conservative management of significant traumatic pneumothoraces is non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness, and quality of life. Objectives: a) To establish if initial conservative management is non-inferior to invasive management regarding subsequent emergency pleural intervention over 30 days (or until death if sooner). b) To determine whether conservative management improves health-related quality of life and other patient reported outcomes. c) To determine the clinical and cost effectiveness of conservative management by measuring length of hospital stay, mortality and costs over the six months following injury. d) To assess acceptability of initial conservative management to patients and clinicians. Methods A multicentre, parallel group, individually randomised controlled non-inferiority trial with an internal pilot, economic evaluation and nested qualitative study in 25 hospitals in England and Wales. 750 adult patients with traumatic pneumothorax, in whom the treating clinician(s) are uncertain if a chest drain is required will be randomised 1:1 to either conservative management (intervention) or chest drain (control). The primary outcome is blinded adjudicated subsequent emergency pleural intervention within 30 days (or until death if sooner) following injury (excluding initial chest drain in the Emergency Department). Secondary outcomes will assess possible advantages of conservative management in terms of reduced pain, complications and improved quality of life. We will conclude that the study population can be managed conservatively if the incidence of subsequent emergency pleural intervention is no more than 7.5% higher in the intervention group than in the control group, allowing non-inferiority to be concluded with 90% power when comparing a one-sided 97.5% confidence interval. Timelines (months) Approvals: (1-2), Pilot site set-up: (3-5), Pilot Recruitment: (6-11), All site recruitment: (12-23), Follow-up: (24-29), Analysis, dissemination: (30-36) Anticipated impact and Dissemination Our pragmatic design allows potential for results to be translated rapidly into clinical practice. We will publish our primary manuscript in a high impact medical journal, and present our findings at multiple conferences. We will communicate our findings to the British Thoracic Society, NICE and NHS England to incorporate our work into relevant national guidelines and develop a film about the project with the help of involved patients and our patient advisors to ensure our findings reach diverse audiences.
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