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Contact Information:

Dr Study Team
None available
prince-ssp@exeter.ac.uk


Prof Nick Maskell
None available
nick.maskell@bristol.ac.uk


Prof Nick Maskell
None available
nick.maskell@bristol.ac.uk


Dr Steven Walker
+44 (0)117 4148114
steven.walker@bristol.ac.uk


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Be Part of Research - Trial Details - Randomised controlled trial investigating needle aspiration versus chest drain for secondary spontaneous pneumothorax
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Randomised controlled trial investigating needle aspiration versus chest drain for secondary spontaneous pneumothorax

Recruiting

Open to: All Genders

Age: Adult

Bristol Bath Sheffield Hull Plymouth London

Medical Conditions

Secondary 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.


Secondary spontaneous pneumothorax (SSP) is where an abnormal collection of air develops in the space between the lung and the chest wall causing lung collapse. This type of pneumothorax is called secondary as it happens in patients with pre-existing lung conditions such as emphysema and is called spontaneous as it occurs without injury. Currently, SSP is typically treated by inserting a drain into the chest to remove the air. The drain usually stays in place for a week leading to a long hospital stay. A different procedure, needle aspiration, involves inserting a small plastic tube into the chest and removing the air with a syringe over roughly 20 minutes. This is a simpler procedure which means patients may avoid the need to have a chest drain. A previous small study found that patients spent less time in the hospital, and had fewer complications when treated with a needle aspiration. However, because only a small number of people were included in this study, we cannot be completely sure of the results. The PRINCE-SSP study would like to confirm these findings in a bigger study.

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 Jun 2023 17 Apr 2025

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39725415/ (added 17/01/2025)

Participants are randomised to receive either needle aspiration or chest drain (usual care). Needle aspiration involves inserting a small needle into the chest and the air is manually aspirated to remove the air. A chest drain involves the insertion of a drain into the chest wall which is stitched in place and attached to a drainage system. A chest drain stays in place for at least 24 hours and requires hospital admission. Needle aspiration takes approximately 20 minutes and is a one-off procedure. Participants will be asked some questions within the first 24 hours after their treatment and will receive a routine chest x-ray before they are discharged. Participants will be asked to complete some questionnaires on days 1 to 5 after their treatment and if they have been discharged home before day 5 they will be given a diary to take home and record some information. Participants will then attend a routine 30-day follow-up appointment where they will be asked some more questions and receive another chest x-ray. A researcher will also look at relevant sections of participants’ medical notes to record details of their care (e.g. how long they stayed in the hospital) and any complications they might have experienced.


Adults who have a symptomatic SSP if the pneumothorax is of sufficient size and symptoms would require intervention with a chest drain

You can take part if:



You may not be able to take part if:


Patients will be excluded if there is:1. Bilateral pneumothorax2. Traumatic or iatrogenic pneumothorax3. Clinical concerns of tension pneumothorax 4. Age <18 years of age 5. Known pregnancy


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

  • Southmead Hospital
    Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • Royal United Hospitals Bath NHS Foundation Trust
    Combe Park
    Bath
    BA1 3NG
  • Northern General Hospital
    Herries Road
    Sheffield
    S5 7AU
  • Hull Royal Infirmary
    Anlaby Road
    Hull
    HU3 2JZ
  • Derriford Hospital
    Derriford Road Derriford
    Plymouth
    PL6 8DH
  • St Thomas' Hospital
    Westminster Bridge Road
    London
    SE1 7EH

Both treatments have advantages and disadvantages and this research will help determine whether doctors should change their practice for the treatment of SSP. There are no direct benefits from taking part in the trial. Both needle aspiration and chest drain are standard treatments used to treat various types of pneumothorax. If needle aspiration is not successful then a chest drain may need to be inserted after the needle aspiration to drain the air between the lung and chest wall. This could be seen as a delay in having the chest drained and the pneumothorax could worsen with time. Participants will be closely monitored throughout the study. Chest X-rays are performed as part of participants’ routine care and participants will not undergo any additional chest X-rays in this trial.

Prof Nick Maskell
None available
nick.maskell@bristol.ac.uk


Dr Steven Walker
+44 (0)117 4148114
steven.walker@bristol.ac.uk


Dr Study Team
None available
prince-ssp@exeter.ac.uk


Prof Nick Maskell
None available
nick.maskell@bristol.ac.uk



The study is sponsored by North Bristol NHS Trust and funded by Research for Patient Benefit Programme.



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Read full details for Trial ID: ISRCTN12644940

Or CPMS 55271

Last updated 17 January 2025

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