Title: Randomised trial of Suction for Primary Pneumothorax Early Resolution
Funder: Department of Health and Social Care

Abstract: Aim_x000D_ We aim to understand whether using suction to treat people in hospital with a lung collapse is safe, and can shorten the time people need to have the chest tube in place._x000D_ _x000D_ Background_x000D_ A pneumothorax occurs when air gets into the space between the lung and the chest wall, usually through a small hole in the lung. This causes the lung to collapse, and can occur “spontaneously”, meaning without an injury to the chest. Primary spontaneous pneumothorax (PSP) occurs in young patients without known lung disease. Most patients with PSP need to have a tube (or drain) inserted into the chest to remove the air between the lung and chest wall. This allows the lung to re-inflate. The tube is attached to a bottle with water in it, creating an underwater seal, and air bubbles out through the water._x000D_ _x000D_ Although some patients with PSP can be treated at home (either by not draining the chest, or with a home drainage device), at least 50% of patients stay in hospital waiting for the lung to re-inflate for 4 to 8 days. In these patients, it is possible to provide suction (negative pressure) to the drain with the aim of expanding the lung more quickly and reducing time in hospital. However, we do not know if using suction is helpful, or if it has risks. There have been no large studies conducted to prove whether suction is effective in reducing treatment time. The current guidelines provide conflicting advice on the routine use of suction, but despite this, doctors often use it. We want to address this question directly._x000D_ Reducing treatment time is important because interviews and questionnaires conducted with patients who have had a pneumothorax have told us that their top priorities are: 1) To reduce the amount of time that they have a chest tube, and 2) To reduce the length of their hospital stay. In addition, treating these patients in hospital costs the NHS around £7.2m per year, so reducing time in hospital safely will be cost saving for the NHS._x000D_ _x000D_ Design and methods_x000D_ We will recruit 450 patients from 36 centres around the UK over 3 years. We have chosen sites that recruited well to our last big pneumothorax study, and these sites have already expressed an interest in the proposed study. Patients will be randomly assigned to either have suction applied to their chest tube, or treated with usual care (no suction) as per current guidelines._x000D_ _x000D_ Patient and public involvement_x000D_ We conducted a survey of twelve patients to find out what was most important to them, and designed this trial based on the results. The survey showed that patients wanted a treatment that reduced the length of treatment and hence time in hospital. A representative from our patient group who previously had a PSP is a co-applicant who will sit on the trial committee and represent our Patient Advisory Group._x000D_ _x000D_ Dissemination_x000D_ If we find treating lung collapse with suction is safe, effective and acceptable to patients, this will lead to changes in management. Results will be written up in scientific journals, presented at conferences and we will work with mainstream and social media groups to let doctors know the findings. We expect our research will be reflected in national guidelines. Our patient groups will help us decide the best ways to let patients know about the results. These will include newsletters, social and traditional media and through lung disease charities.

Lay abstract: Research Question_x000D_ Is early use of thoracic suction superior to standard care (no suction) in patients with Primary Spontaneous Pneumothorax (PSP) requiring treatment, by reducing the duration of treatment and without excess adverse effects?_x000D_ Our rationale is that suction may achieve this by: _x000D_ 1) More quickly re-expand the lung (reducing the size of pneumothorax) by providing negative pressure in the pleural space. _x000D_ 2) Earlier cessation of air leak by creating apposition of the lung to the chest wall, which aids healing._x000D_ _x000D_ Background_x000D_ Primary spontaneous Pneumothorax (PSP) typically affects young patients and is caused by a spontaneous hole occurring in the lung, thus leaking air into the pleural space. Contemporary guidelines focus on treating the pneumothorax either with short-term drainage (needle aspiration) or intercostal chest drain (ICD), which typically requires admission, resulting in 3,000 admissions/year in the UK._x000D_ Once admitted to hospital with a chest drain, median hospital stay is 4-8 days, and management remains contentious. Suction, which is the application of negative pressure to the pleural space via the chest drain, is sometimes used to expand the lung more quickly. However, suction is not without risk; it may precipitate injury to the lung or delay healing by maintaining flow through the hole in the lung._x000D_ The use of suction in PSP is thus controversial, highly variable, and inconsistent in current practice and has potential risks and benefits. We therefore propose a definitive study to evaluate whether early suction in admitted patients with PSP is safe and effective for outcomes important to patients and the NHS._x000D_ _x000D_ Aims and objectives_x000D_ Aim: To evaluate whether use of early suction can reduce treatment duration for patients with PSP compared to usual care (no suction)._x000D_ _x000D_ Objectives:_x000D_ 1) To test whether use of suction is superior to usual care with respect to total treatment time (time with a drain in the thorax including post-surgery)_x000D_ 2) To estimate the difference between groups with respect to a range of patient-reported and clinical secondary outcomes up to 6 months_x000D_ 3) To estimate the cost-effectiveness of suction compared to standard management_x000D_ 4) To determine the risk profile of suction use compared with standard care_x000D_ _x000D_ Methods_x000D_ A multicentre, parallel, individually randomised controlled superiority trial in 36 hospitals in England, Scotland and Wales. 450 adult patients with PSP managed in hospital with chest drainage will be randomised between immediate use of suction (intervention) or usual care (control)._x000D_ The primary outcome measure is total treatment time. Secondary outcomes will assess length of hospitalisation, pain and breathless scores, patient-related health status, complications, in patient surgical rates, overall number of pleural procedures, recurrence rates, healthcare utilisation & costs, and cost-effectiveness._x000D_ _x000D_ Timeline_x000D_ 48-month project: Set-up (6 months); pilot recruitment (12 months); further recruitment (23 months); follow-up (minimum 1 month follow-up), study close-down analysis and reporting (6 months)._x000D_ _x000D_ Anticipated impact and dissemination_x000D_ Findings from this trial will have a substantial impact on the current in-patient management of PSP by determining the role of suction and will be incorporated into international guidelines. Results will be submitted to major international meetings, for publication in a high impact medical journal and on social media platform

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RESPIRATORY