PRINCE-SSP
Research type
Research Study
Full title
Pragmatic non-inferiority Randomised trial Investigating Needle aspiration versus ChEst drain for Secondary Spontaneous Pneumothorax
IRAS ID
324020
Contact name
Nick Maskell
Contact email
Sponsor organisation
North Bristol NHS Trust
ISRCTN Number
ISRCTN12644940
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
"Research Summary"
We are testing whether needle aspiration (NA) is no worse compared to intercostal chest drain (ICD; usual care) in patients with secondary spontaneous pneumothorax (SSP). Our primary interest is whether patients treated with NA reduces the initial length of stay in hospital. Secondary outcomes will also look at any benefits in other patient-reported, clinical and cost-effectiveness outcomes.NA has been shown to reduce length of hospital stay and lower complication rates in patients with pneumothoraces with no known underlying lung disease (primary spontaneous pneumothorax, PSP) when compared with more invasive ICD. SSP, defined as a pneumothorax occurring in the presence of lung disease, is more common and results in much poorer patient outcomes than PSPs. SSPs are however still managed with ICDs, as this standard care has not been challenged in high-quality randomised studies.
110 participants will be recruited from roughly 15 UK emergency medicine/hospital sites. As this is an emergency treatment, if a patient is deemed not to have capacity to consent to treatment they will be enrolled in the trial. If the participant regains capacity within 72 hours of treatment, they will be approached to see whether they would like to continue in the trial. If capacity is not resumed, we will approach a consultee. Half the participants will receive NA and half ICD. Participants will be asked some questions on days 1 to 5 after treatment and will also be asked to attend a hospital visit on day 30. We will also collect data from the participant’s medical notes to record details of their care e.g. any complications experienced.
We anticipate the results of the trial will be of high clinical importance and will be incorporated into clinical practice guidelines for the management of SSP.
"Summary of Results"
A secondary spontaneous pneumothorax (SSP) occurs when a lung suddenly collapses in someone who has an underlying lung condition, such as chronic obstructive pulmonary disease (COPD). SSP can cause breathlessness and chest pain and often requires treatment in hospital.The usual treatment for SSP is to insert a chest drain: a plastic tube placed between the ribs and into the chest to remove the trapped air and allow the lung to re-expand. Chest drains can be uncomfortable and usually require patients to remain in hospital while the drain is in place.
The PRINCE-SSP study investigated whether a less invasive treatment called needle aspiration could be used instead. Needle aspiration involves inserting a small tube or needle into the chest to remove the trapped air. The tube is then removed after the procedure, avoiding the need to leave a chest drain in place.
The study took place in 20 hospitals across the UK. Between August 2023 and April 2025, 72 patients with SSP were randomly allocated to receive either needle aspiration or the usual treatment with a chest drain.
Patients treated with needle aspiration had a substantially shorter initial hospital stay. On average, the difference between the groups was approximately 5 days, with patients receiving needle aspiration spending less time in hospital. Complications were similar between the two groups.
However, there were some disadvantages to needle aspiration. Patients initially treated with needle aspiration were more likely to require another procedure to treat their pneumothorax and were more likely to be readmitted to hospital within 30 days.Overall, the PRINCE-SSP study found that needle aspiration can reduce the initial time spent in hospital for patients with SSP without increasing complications. However, this needs to be balanced against a greater chance of needing further treatment or returning to hospital. These findings provide important new information to help patients and healthcare professionals make decisions about how SSP should be treated.
REC name
Wales REC 7
REC reference
23/WA/0085
Date of REC Opinion
28 Mar 2023
REC opinion
Favourable Opinion