Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Nick Maskell
+441174148048
nick.maskell@bristol.ac.uk


Miss Lucy Hamilton
+44 117 455 4092
consept-trial@bristol.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Treating people with a lung collapse (pneumothorax) without inserting a needle into the chest. Is it safe and effective?
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Treating people with a lung collapse (pneumothorax) without inserting a needle into the chest. Is it safe and effective?

Recruiting

Open to: All Genders

Age: Mixed

Bristol Newport Stoke-on-trent Cambridge Reading Plymouth Birmingham Kirkcaldy Oxford Lothian Cramlington Blackpool Bath London Leicester Northampton

Medical Conditions

Primary spontaneous pneumothorax

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2023 01 Jun 2026

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.


Patients with PSP aged between 16 and 50 years old

You can take part if:



You may not be able to take part if:


1. Known or suspected underlying lung disease* 2. Evidence of clinical tension pneumothorax3. SpO2 <92% on air 4. Bilateral pneumothorax5. Pregnancy6. Inability to consent or comply with trial requirements

* “Childhood asthma” or well-controlled asthma is not considered an exclusion criterion. Patients with a diagnosis of asthma in childhood/young adulthood who do not require the use of a regular “preventer” inhaler (i.e. inhaler containing a steroid or long-acting beta-agonist), and only occasionally use a “reliever” inhaler (short-acting beta-agonist) and have never been hospitalised due to asthma remain eligible for participation in this study.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • North Bristol NHS Trust
    Southmead Hospital Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • Royal Gwent Hospital
    Cardiff Road
    Newport
    NP20 2UB
  • Royal Stoke University Hospital
    Newcastle Road
    Stoke-on-trent
    ST4 6QG
  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Royal Berkshire Hospital
    Royal Berkshire Hospital London Road
    Reading
    RG1 5AN
  • Derriford Hospital
    Derriford Road Derriford
    Plymouth
    PL6 8DH
  • University Hospital Birmingham
    Queen Elizabeth Hospital Edgbaston
    Birmingham
    B15 2TH
  • Victoria Hospital
    Hayfield Road
    Kirkcaldy
    KY2 5AH
  • Oxford University Hospitals
    John Radcliffe Hospital Headley Way Headington
    Oxford
    OX3 9DU
  • Royal Infirmary of Edinburgh at Little France
    51 Little France Crescent Old Dalkeith Road Edinburgh
    Lothian
    EH16 4SA
  • Northumbria Specialist Emergency Care Hospital
    Northumbria Way
    Cramlington
    NE23 6NZ
  • Blackpool Victoria Hospital
    Whinney Heys Road
    Blackpool
    FY3 8NR
  • Royal United Hospital
    Combe Park
    Bath
    BA1 3NG
  • The Guys and Lewisham NHS Trust
    Guys Hospital St Thomas Street
    London
    SE1 9RT
  • Glenfield General Hospital
    Groby Road
    Leicester
    LE3 9QP
  • Queensview Medical Centre
    Thornton Road
    Northampton
    NN2 6LS

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.

Prof Nick Maskell
+441174148048
nick.maskell@bristol.ac.uk


Miss Lucy Hamilton
+44 117 455 4092
consept-trial@bristol.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by North Bristol NHS Trust and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN75384510

Or CPMS 54952

Last updated 24 February 2023

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