Randomised Ambulatory Management of Primary Pneumothorax (RAMPP)
Research type
Research Study
Full title
Randomised Ambulatory Management of Primary Pneumothorax (RAMPP).
IRAS ID
165189
Contact name
Najib Rahman
Contact email
Sponsor organisation
CTRG, University of Oxford
Clinicaltrials.gov Identifier
OCTRU ID:, CTU0018
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
Research Summary:
Pneumothorax - air in the pleural space - is common (~3,000 patients per year in the UK). Primary spontaneous pneumothorax (PSP) is said to occur, in the absence of trauma, in patients with no underlying established lung disease. Some patients are managed conservatively with close observation only; however, many patients will require an intervention to re-inflate the lung. In some cases aspiration of air using cannula and syringe will be sufficient, but many will need to have a chest drain inserted with standard underwater seal with the average duration of in-patient stay of 6-8 days. Portable/’ambulatory’ devices (such as Rocket Pleural Vent) provide the option to treat these patients as an outpatient while their lung re-inflates.
RAMPP is an interventional multi-centre (UK only) randomised controlled trial comparing ambulatory to standard (in-patient treatment with aspiration/chest drain) management of primary pneumothorax. Primary outcome is total hospital stay up to 30 days post-randomisation. The study will also investigate whether digitally measured air leak can predict short term outcome (prolonged air leak and requirement for surgery) and whether radiological evidence (on CT scanning) of emphysema-like change and inflammation can predict long term outcome (recurrence rates at 12 months). Patients will have baseline observations and blood tests and then will be reviewed daily either on the ward (standard management group) or as an outpatient (ambulatory group) with chest x-ray, air leak measurement and assessment of breathlessness and chest discomfort. Patients who do not require treatment, after their initial assessment, can be discharged but return for follow up. All patients will be followed-up at 1 week post treatment completion (including a CT scan), and then at 1, 6 & 12 months post enrolment.
The study is funded by the NIHR Research for Patient Benefit Programme and an MRC Fellowship grant.
Summary of Results:
Background Pneumothorax - air in the pleural space - is common and affects ~3,000 patients per year in the UK. Primary spontaneous pneumothorax (PSP) is said to occur, in the absence of trauma, in patients with no underlying established lung disease. Many patients will require a procedure to re-inflate the lung. In some cases aspiration of air using cannula and syringe will be sufficient, but many will need to have a chest drain inserted with standard underwater seal with the average duration of in-patient stay of 6-8 days. Portable/'ambulatory' devices (such as Rocket Pleural Vent) provide the option to treat such patients as outpatients while their lung re-inflates.
Aims and objectives
RAMPP was an interventional multi-centre randomised controlled trial comparing ambulatory to standard treatment to see if ambulatory management could safely reduce the amount of time the patient spends in hopsital.
Methods
Over a period of 3 years, we recruited patients with PSP from 24 UK hospitals. Patients were randomly assigned to treatment with either an ambulatory device or standard treatment. The primary outcome was total length of hospital stay including re-admission up to 30 days after enrolment. We also recorded information on pain and breathlessness, whether the patients needed any more procedures, and whether they had another pneumothorax needing treatment over the next 12 months.
Key Findings
236 patients were randomised. At 30 days, the hospital stay in the ambulatory group was shorter (median 0 days) compared with those who received standard care (median 4 days). Patients in the ambulatory group had fewer procedures overall, but were more likely to have a complication which required them to be readmitted to hospital (usually for a new chest drain). However, there was no difference in amount of pain or breathlessness between the two groups and non-serious complications were also similar.REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0240
Date of REC Opinion
8 May 2015
REC opinion
Favourable Opinion