ACTION trial. Version 1.0
Research type
Research Study
Full title
Aspiration versus Chest Tube drainage in pleural infectION (ACTion) trial
IRAS ID
260019
Contact name
David Arnold
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
When people get chest infections, fluid can sometimes build up around the lung. This is called a pleural effusion. In about 1 in 10 cases, the fluid itself becomes infected, this is called pleural infection. Pleural infection is usually treated by removing the infected fluid, and using antibiotics to mop up the left-over infection. The most common method to remove the fluid is to insert a chest tube (about 6mm across) through the chest wall, to allow fluid to drain into a collection bottle. This tube stays in until all the fluid has come out, which is usually between 3-5 days, although it can be much longer. The drain can be sore, and prevents people moving around normally. Patients need to stay in hospital whilst the drain is in position. The average hospital stay for pleural infection is 13 days, placing a significant burden on patients, their families, and the health service.
An alternative to chest tube drainage is a procedure called therapeutic thoracentesis (TT). This involves inserting a smaller (3mm) tube into the fluid and drawing off as much as possible, over 20 minutes or so, before removing the tube. This can be repeated if the fluid builds up again. This method allows patients to move around freely between procedures and even be managed out of hospital. However, we do not know whether TT might mean it takes longer for the infection to fully clear. Although some hospitals in Europe use TT for pleural infection, no studies have ever directly compared chest tubes to TT.
The ACTion trial is a feasibility (test) trial to assess whether a full-scale trial would be possible, safe and acceptable for patients. Before starting, we will involve patients who have had pleural infection to get their input on improving the trial design and processes.
In the trial, information will be collected on all patients who are admitted to Southmead hospital with pleural infection. Provided they don’t have a particularly complicated pleural infection they will be invited to participate. Thirty participants will be randomly allocated to have either chest tube or TT. Information on hospital stay and quality of life will be collected. However, the main outcome will be whether a full-scale trial would be possible (were participants willing to take part). We will also be interviewing patients and health professionals who took part to get their opinions on the trial processes and possible improvements.REC name
Wales REC 7
REC reference
19/WA/0200
Date of REC Opinion
10 Jul 2019
REC opinion
Further Information Favourable Opinion