Randomised ambulatory management of primary pneumothorax (RAMPP)
- Conditions
- PneumothoraxRespiratory
- Registration Number
- ISRCTN79151659
- Lead Sponsor
- CTRG (University of Oxford)
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32622394/ results (added 06/07/2020) 2022 Other publications in http://dx.doi.org/10.1136/thoraxjnl-2021-218479 Cost-effectiveness (added 12/09/2023) 2019 Protocol article in http://dx.doi.org/10.1136/bmjresp-2019-000403 (added 12/09/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 236
1. Presenting with primary spontaneous pneumothorax as confirmed by a chest radiograph or a CT scan
2. Age >= 16 years old and <= 55 years old
3. Ability to consent to participation
1. Known or suspected underlying lung disease (including >20 pack year smoking history)
2. Evidence of tension pneumothorax (these patients should be treated immediately as medical emergencies).
3. Females who are pregnant or lactating
4. Inability to consent or comply with the trial requirements
5. Contraindication to thoracic procedure. (Only applies to patients being enrolled into Intervention or Control arms – i.e. not observational cohort)
6. 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 trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess whether use of an ambulatory device (Rocket Pleural Vent) and treatment strategy reduces hospital stay.Total length of stay in hospital up to 30 days post randomisation.Up to 30 days post randomisation.
- Secondary Outcome Measures
Name Time Method