Title: Conservative Management in Traumatic Pneumothoraces in the Emergency Department (CoMiT-ED): A Randomised Controlled Trial
Funder: Department of Health and Social Care

Abstract: Aim_x000D_ To find out whether a collapsed lung (pneumothorax) due to injury (trauma) can be safely and effectively treated without immediately inserting a tube into the chest (chest drain)._x000D_ _x000D_ Background_x000D_ A collapsed lung often occurs following trauma such as falls in older people, road traffic accidents or stabbings. For years, doctors have treated this by cutting a hole between the ribs and inserting a tube (chest drain) to help the lung re-inflate. Every year, around 25,000 trauma patients have this procedure in England and Wales. Although routinely used in the NHS, chest drains can be painful, lead to infection and cause scarring of the chest. Our previous research suggests that more patients with a collapsed lung could be safely treated without a chest drain, but clinicians are often unsure about which approach will work best. We are proposing to find out whether, for some patients, it would be clinically safe, effective and acceptable to treat without a chest drain. _x000D_ _x000D_ Design and methods_x000D_ We will recruit 750 adult patients with a collapsed lung after trauma in 25 hospital Emergency Departments. Patients will be approached to take part in the study if a scan or X-ray shows them to have a collapsed lung and their treating clinician is unsure whether a chest drain is needed or not. The decision to insert a chest drain or not will need to be made quickly as patients have major injuries. Where possible, we will ask patients who are able to tell us if they want to take part, before they are put into the study. If this is not possible, due to their injuries, we will seek advice from a close relative at a later stage in their hospital care about their ongoing involvement. Participants will each be allocated to one of the two study groups at random. One group of patients will not have a chest drain and the other group will have a chest drain. Afterwards, we will carefully monitor patients in both groups, and compare the two groups to see which patients needed a chest drain or similar procedure over the next 30 days and if any problems with breathing, pain or general health developed over the next 6 months. We will monitor the safety of the study with an independent committee. We will interview some patients to understand their experience of being treated with or without a chest drain and will investigate which approach achieves the best use of NHS resources._x000D_ _x000D_ Patient and public involvement_x000D_ Chest injuries affect many different people. We have identified three groups that are most likely to be involved in this research; older patients who have chest injuries after a fall, patients who suffer multiple injuries following major accidents and young victims of knife crime. Representatives of all three groups have helped us design this research and will continue to form our patient advisory groups to provide input throughout the trial._x000D_ _x000D_ Dissemination_x000D_ This study will tell us whether treating a collapsed lung after trauma without a chest drain is safe, effective and acceptable to patients. It will inform NHS clinicians about the best treatment for a collapsed lung and may reduce the number of these painful procedures conducted each year. Our results will be published in scientific journals and presented at conferences. We will also create a short video about the study by working with our patient advisory groups to make the findings more widely known to clinicians and patients and include patient stories to bring the topic to life.

Lay abstract: Research Question_x000D_ 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?_x000D_ _x000D_ Background_x000D_ 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._x000D_ _x000D_ Aims and Objectives_x000D_ 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._x000D_ Objectives: _x000D_ 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)._x000D_ b) To determine whether conservative management improves health-related quality of life and other patient reported outcomes._x000D_ 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._x000D_ d) To assess acceptability of initial conservative management to patients and clinicians._x000D_ _x000D_ Methods_x000D_ 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._x000D_ _x000D_ Timelines (months)_x000D_ 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)_x000D_ _x000D_ Anticipated impact and Dissemination_x000D_ 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.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS