CONservative versus Standard carE for primary spontaneous PneumoThorax (CONSEPT)
Status: In set up
Sponsor : North Bristol NHS Trust
We aim to understand whether treating people with a lung collapse (pneumothorax) without inserting a needle into the chest is safe and effective. Primary spontaneous pneumothorax (PSP) is an abnormal collection of air in the space between the lung and the chest wall, causing collapse of the lung. This type of pneumothorax is called primary, as it happens in patients with no underlying lung disease, and spontaneous, as it occurs without injury. Previous work by our group shows that 3,000 patients/year need admission to hospital. Currently, patients with symptoms are treated by draining the air through a needle or tube put into the chest, as it is thought to reduce symptoms of pain and breathlessness and speed recovery. This treatment means patients often stay in hospital for 1 week and puts patients at risk of complications from treatment (for example, infection). Patients whose lung has only partially collapsed (small PSP) or who have fewer symptoms can be managed conservatively , this means not draining the air, and being observed instead. However, it is not clear whether it is safe to do this in patients with symptoms and a larger collapse (large PSP). We will conduct a study to investigate whether conservative care in symptomatic PSP is safe and effective using outcomes that are important to patients, such as the need for invasive treatments and length of hospital stay. We will study 638 patients with PSP who are admitted to hospital. Patients will be put into one of two groups by chance. The first group will not have a needle or drain but will be monitored for a few hours, and if comfortable and stable, discharged from hospital. The second group will be treated in the usual way (by evacuating air with a needle or drain). We will collect information to see if patients need to have subsequent invasive treatment in the first month after the pneumothorax, and measure symptoms and general health. We will also monitor how often the pneumothorax recurs over a year.
Funding Statement: HTA NIHR133653
Chief Investigator: Professor Nick Maskell and Professor Najib Rahman
Trial Coordinator: Lucy Hamilton
Study Email: firstname.lastname@example.org