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
Duration of Study in the UK
2 years, 4 months, 31 days
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.
REC name
Wales REC 7
REC reference
23/WA/0085
Date of REC Opinion
28 Mar 2023
REC opinion
Favourable Opinion