Primary spontaneous pneumothorax Respiratory
Conditions
Interventions
RASPER is a multi-centre open-label randomised controlled trial of patients with primary spontaneous pneumothorax (PSP) requiring treatment in the hospital. The aim of the study is to assess the super
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
16 Years to 60 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/05/2025: 1. Participants with primary spontaneous pneumothorax (PSP) (either first or recurrent episode) 2. Male and Female aged 16* to 50 years old OR aged 51 to 60 years old without significant smoking history 3. Pneumothorax requiring chest drain in hospital (ideally within 24 hours of drain insertion, but up to 72 hours)) 4. Willing and able to give written consent 5. Access to an electronic device for questionnaire completion *Common law presumes that young people aged between 16 and 18 years old are usually competent to give consent to treatment and consent from those with parental responsibility is not legally necessary. Eligible young persons believed to be competent by the PI or delegate should be approached about the study. The involvement of parents in decision-making should be encouraged unless the young person objects. _____ Previous inclusion criteria: 1. Participants with primary spontaneous pneumothorax (PSP) (either first or recurrent episode) 2. Male and Female aged 16* to 50 years old 3. Pneumothorax requiring chest drain in hospital (ideally within 24 hours of drain insertion, but up to 72 hours)) 4. Willing and able to give written consent 5. Access to an electronic device for questionnaire completion *Common law presumes that young people aged between 16 and 18 years old are usually competent to give consent to treatment and consent from those with parental responsibility is not legally necessary. Eligible young persons believed to be competent by the PI or delegate should be approached about the study. The involvement of parents in decision-making should be encouraged unless the young person objects.
Exclusion criteria
Exclusion criteria: 1. Known or suspected underlying lung disease**. This does not include the presence of blebs/bullae on CT chest in the absence of another specific respiratory diagnosis 2. Inability to consent or comply with trial requirements 3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant’s ability to participate in the study. **“Childhood 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total treatment duration, defined as the time from randomisation to completion of pleural treatment (including surgery, if required), measured using data recorded in patient medical notes at the completion of treatment (discharge home from hospital with no drain in place) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcomes measured using data recorded in patient medical notes: 1.1. In-patient surgical rates at the completion of treatment 1.2. Length of hospital stay over first the 30 days post-randomisation (including readmissions) at 30 days post-randomisation 1.3. Pain and breathless scores (100mm Visual Analogue Scale (VAS)) at baseline, daily until completion of treatment, and at follow-14 days after the completion of treatment and 30 days post-randomisation) 1.4. EQ5D at baseline, Completion of treatment, 30 days and 6 months post-randomisation 1.5. Rate of recurrence of pneumothorax at 6 months post-randomisation 2. Incremental cost per quality-adjusted life years (QALYs) gained at randomisation to 6 months measured using data gathered between those timepoints 3.1. Complication rates at the completion of treatment 3.2. Overall number of in-patient pleural procedures at the completion of treatment 3.3. Adverse events related to the use of suction at the completion of treatment | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma Hedley
Outcome results
None listed