Title: The Randomised Ambulatory Management of Primary Pneumothorax Study (RAMPP) - Ambulatory chest catheter drainage devices (Pneumovent) in the treatment of primary pneumothorax – randomised trial to assess early discharge and outpatient management
Funder: Department of Health and Social Care

Abstract: Background: Primary spontaneous pneumothorax (PSP) is a common cause of morbidity, resulting in compression of the lung, chest pain and breathlessness. PSP occurs in patients in the absence of a predisposing lung condition and ~5,000 patients / year experience PSP in the UK. There is no clear consensus opinion on the optimal management strategy - a minority can be managed with observation only, but for those requiring treatment, simple aspiration (short term drainage) or chest drain insertion and connection to a drainage bottle are performed. These young patients, with few other illnesses, require swift and effective treatment to return to full health and work status quickly. When managed with chest drainage and standard underwater seal (~50% of patients), the average duration of in-patient stay is 6-8 days. Prolonged immobility and in hospital stay increases the risks of thromboembolism and hospital acquired infection, as well as associated healthcare cost (estimated &pound;1575 / patient in hospital stay costs alone). Prolonged in-patient management of PSP may also delay return to work. Ambulatory treatment strategies offer the potential to improve efficacy, comfort and quality of care in PSP. Single, small devices, incorporating a drainage catheter and one way valve system, can be inserted to control the pneumothorax and improve mobility on the ward, and have the potential to drastically reduce unnecessary hospital stay by allowing discharge with the device in situ while the pneumothorax spontaneously heals. Previous small studies have demonstrated feasibility of ambulatory devices to allow outpatient management of PSP, but are currently not in standard use. Aims and question to be addressed The central question is whether an ambulatory treatment strategy can improve hospital stay, patient related outcomes and cost compared to current standard (chest drain and drainage bottle) care in PSP. Specific aims of the research are: To assess whether use of an ambulatory treatment strategy reduces hospital stay (primary). To assess whether ambulatory care and early discharge is safe and cost-effective in the treatment of PSP (secondary) To determine whether patient experience is improved with ambulatory treatment (secondary): Pain of procedure and discomfort of device: Visual Analogue Scale (VAS) scores Time to full ambulation (Barthel Index) Quantitative measurement of daily level of activity using Actigraphy. Quality of life assessments (EQ-5D-5L, SQRQ) Time to return to working status To assess recurrence rate of pneumothorax at 6 months Plan of Investigation This study proposes a definitive randomised controlled trial comparing an ambulatory strategy (using &ldquo;Pneumovent&rdquo;, Rocket Medical UK) with standard care (pleural aspiration +/- subsequent chest drain insertion with underwater seal based on national guidelines) in 210 patients across 5 UK centres. Outcomes will be assessed in the domains of clinical outcomes, patient related outcomes and health economic outcomes. The primary outcome is length of hospital stay. Chest pain and breathlessness will be monitored using Visual Analogue Scale scores and assessments of quality of life will be made. Complications, recurrence rates, need for further pleural procedures or surgical referral and health economic implications will be assessed. Summary of Potential benefits to patients and the NHS Definitive demonstration of safety and efficacy of ambulatory treatment in PSP has the potential to revolutionise the treatment of this common condition. This may alter current in-patient treatment to out-patient based treatment, reducing hospital stay and its costs. Patient recovery, pain, quality of life and return to work may potentially be improved with ambulatory treatment. The potential benefits to the NHS are large, with an estimated 5000 patients / year experiencing pneumothorax, and an estimated current cost in bed days of ~&pound;4million / year.

Lay abstract: The presence of air around the lung (pneumothorax) causes the lung to collapse and causes significant pain and breathing difficulties. This occurs in around 5,000 people per year in the UK. These young patients, with few other illnesses, need to be treated swiftly and effectively, in order to return to health and to work quickly. Patients are usually treated by either using a needle in to the chest to withdraw some of the air (aspiration), or by placing a plastic tube in the chest (chest drain) to help re-inflate the lung. This is connected to a drainage bottle and requires the patient to remain in hospital for 6-8 days, causing prolonged immobility and hospital stay which could be harmful to health, and is costly. A portable drainage device (Pneumovent, Rocket Medical) may allow patients to be treated more effectively, allowing more mobility while in hospital and potentially allowing discharge home with the device while the pneumothorax heals. The main aim of this study is to measure how long patients spend in hospital using the portable device compared to standard care (chest drain and bottle). Other important factors being assessed include safety, the level of comfort of the device, improvement in breathlessness, and how mobile the patients are. This type of device have been used before but not in carefully designed trials to prove benefit against standard treatment. Data will also be gathered about air leak and x-rays, and whether the patient needs any further treatment (such as surgery) which will help to guide future management, and may allow early recognition of patients who may require additional treatment. In addition to the benefit to patients, potential cost savings to the healthcare system will be calculated.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RESPIRATORY