Treating people with a lung collapse (pneumothorax) without inserting a needle into the chest. Is it safe and effective?

Plain English Summary

Background and study aims
Primary spontaneous pneumothorax (PSP) is an abnormal collection of air in the space between the lung and the chest wall, causing the lung to collapse. 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 a 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 the hospital for one week and puts patients at risk of complications from the 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.

Who can participate?
Patients with PSP aged between 16 and 50 years old

What does the study involve?
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 the 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.

What are the possible benefits and risks of participating?
There are no direct benefits from taking part as the research team does not know which treatment is better, however, the information generated by this study may help improve the treatment of people with PSP in the future. The current standard care for PSP is to perform an invasive treatment. This might help people to get better more quickly, but all of these treatments have small risks associated with them, for example, infection. The conservative treatment arm may mean the patient avoids an invasive treatment, but as a result, the pneumothorax might take longer to improve, or the patient might need an invasive treatment further down the line. It also risks the pneumothorax getting worse when the patient is at home having not had the PSP drained. This will be closely monitored throughout the study and the clinical team will ensure the patient is followed up regularly. Patients will have a number of chest X-rays when taking part in the study, one of which may be in addition to those already schedule if not taking part. Chest X-rays use ionising radiation to form images of the body and to provide the doctor with other clinical information. The risk of radiation exposure is that patients may develop cancer some years in the future. Everyone is at risk of developing cancer during their lifetime. The normal risk is that this will happen to about 1 in 2 people at some point in their life. The additional risk from the extra X-ray that may be received as part of the study is very small and is outweighed by the benefit of the information the X-ray provides.

Where is the study run from?
Bristol Trials Centre at the University of Bristol (UK)

When is the study starting and how long is it expected to run for?
November 2021 to February 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (HTA) (UK)

Who is the main contact?
Lucy Hamilton (Trial Manager), consept-trial@bristol.ac.uk (UK)

Study website

Contact information

Prof Nick Maskell
Principal Investigator

Professor of Respiratory Medicine
University of Bristol
Academic Respiratory Unit
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

ORCID ID	0000-0002-1276-6500
Phone	+441174148048
Email	nick.maskell@bristol.ac.uk

Miss Lucy Hamilton
Public

Bristol Trials Centre
University of Bristol
1-5 Whiteladies Road
Clifton
Bristol
BS8 1NU
United Kingdom

Phone	+44 117 455 4092
Email	consept-trial@bristol.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

North Bristol NHS Trust
Hospital/treatment centre

Research and Innovation
North Bristol NHS Trust Floor 3
Learning & Research Building
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
England
United Kingdom

Phone	+44 (0)1174149330
Email	ResearchSponsor@nbt.nhs.uk
Website	http://www.nbt.nhs.uk/
"ROR"	https://ror.org/036x6gt55

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

24/02/2023: The following updates have been made to the study record:
1. The recruitment start date has been changed from 01/03/2023 to 01/04/2023.
2. Ethics approval added.
31/01/2023: Trial's existence confirmed by NIHR (UK).