CONSEPT
Research type
Research Study
Full title
CONservative versus Standard carE for primary spontaneous PneumoThorax (CONSEPT)
IRAS ID
314206
Contact name
Nick Maskell
Contact email
Sponsor organisation
North Bristol NHS Trust
ISRCTN Number
ISRCTN75384510
Duration of Study in the UK
5 years, 3 months, 26 days
Research summary
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 a year need admission to hospital to treat a PSP. 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 one 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). Research published in 2020 from Australasia compared draining the air with observation only in patients with large symptomatic PSP. The researchers found that observation was as good as draining the air but there were problems with the research and, although these results are promising, they have not changed how doctors treat patients.
The CONSEPT trial will investigate whether observation only in patients with a large symptomatic PSP is safe and effective with respect to outcomes that are important to patients, such as the need for invasive treatments and length of hospital stay.
Participants will be put into one of two groups by chance. The observation only group will not have the air drained 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 draining the air through a needle or tube. We will collect information to see if patients need to have a subsequent drainage in the first month after having the PSP, and measure symptoms and general health. We will also monitor whether the PSP recurs within a year.
REC name
Wales REC 7
REC reference
23/WA/0026
Date of REC Opinion
31 Jan 2023
REC opinion
Favourable Opinion