A study to compare a single drainage procedure (therapeutic aspiration) versus a standard chest tube for the initial treatment of infected fluid around the lung
| ISRCTN | ISRCTN99134939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99134939 |
| Integrated Research Application System (IRAS) | 357237 |
| Central Portfolio Management System (CPMS) | 58562 |
| National Institute for Health and Care Research (NIHR) | 159462 |
| Sponsor | North Bristol NHS Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 18/12/2025
- Registration date
- 09/01/2026
- Last edited
- 09/01/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
When people get chest infections, fluid can sometimes build up around the lung. In about 1 in 10 cases, this pleural fluid itself becomes infected and needs drainage. This is called pleural infection. Pleural infection is a serious condition, affecting over 10,000 people per year in the UK. The condition can affect anyone but is more likely to affect those who are elderly or have a weakened immune system. These groups are also the most harmed by long stays in hospital. The current practice to remove the fluid is to insert a chest tube (about 6 mm across) between the ribs, to allow fluid to drain into a collection bottle. This tube stays in place until all the fluid has come out, which usually takes between 3-5 days, but it can take 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. As important as draining the fluid is treating the infection with antibiotics, but there is uncertainty about how well antibiotics work in the infected fluid and how best to give them (through the vein or as tablets). These uncertainties have meant that, unlike for other lung infections, the length of time patients stay in hospital is over a fortnight. These long hospital stays place a burden on the patient, their family, and the NHS. Patients are also given long courses of antibiotics through the vein (intravenous antibiotics), a problem for antibiotic resistance. This study aims to reduce the length of time patients with pleural infection need to stay in hospital by answering two linked questions. Firstly, can we drain the fluid in a better way? Using a less invasive single drainage approach called therapeutic thoracentesis for the infected fluid might allow patients to be more mobile. This study will show whether this approach can safely reduce the number of days patients need to stay in hospital. Secondly, can we improve antibiotic treatment for pleural infection?
Who can participate?
Patients aged 16 years and over admitted to participating hospitals with a pleural infection who satisfy the inclusion criteria and for whom none of the exclusion criteria apply
What does the study involve?
Patients will be randomly assigned to have their fluid drained using a chest tube or therapeutic thoracentesis. We will collect samples of pleural fluid from the patients and antibiotic levels within that fluid will be measured. We will test if how we drain the fluid affects the antibiotic levels. If so, this will encourage doctors to use shorter intravenous courses, removing another barrier to earlier hospital discharge.
What are the possible benefits and risks of participating?
We hope that every patient will gain benefit from the infected fluid being drained, whether it is from a chest tube or therapeutic aspiration. Whichever group you are allocated to, your participation in this study will contribute to our understanding and development of new and better ways of managing pleural infection. This will hopefully benefit patients in the future.
If you are allocated to therapeutic aspiration, there is a possibility that if safe, and with your agreement, you could go home sooner than you might have done with a chest tube.
Both treatments used in this study are regularly performed in the NHS to drain fluid from around the lung. There are very similar risks to both procedures, such as bleeding and discomfort. There is also a possibility that the initial chest tube or therapeutic aspiration does not completely resolve the infection and further treatments are required. Taking blood samples may cause bruising and may cause some people to feel faint.
Where is the study run from?
Oxford Respiratory Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
August 2024 to December 2029
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr David Arnold, David Arnold@nbt.nhs.uk
Contact information
Public, Principal investigator, Scientific
Oxford Respiratory Trials Unit, Churchill Dr, Headington
Oxford
OX3 7LE
United Kingdom
| impact@ndm.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Initial Management of Pleural infection: Aspiration vs Chest Tube (IMPACT) trial |
| Study acronym | IMPACT |
| Study objectives | Primary objective: For adults who present to the hospital with pleural infection, does initial treatment with therapeutic thoracentesis reduce the length of initial hospital stay compared to insertion of a chest tube (standard care)? Secondary objectives: To investigate if the initial treatment with therapeutic thoracentesis changes: 1. Proportion of patients readmitted to hospital within 30 days following discharge 2. Total duration of intravenous antibiotic use 3. Number of pleural procedures performed by 90-day follow-up 4. Number of rescue therapies performed (fibrinolytics or surgery) 5. Patient-reported health-related quality of life (HRQoL) measurements at Day 7 and Day 90 6. Pleural thickening at Day 90 (measured on ultrasound) 7. Mortality at Day 90 |
| Ethics approval(s) | Approved 17/12/2025, Wales REC2 (Health and Care Research Wales, Cardiff, CF11 9AB, UK; +44 (0)2922941119, +44 (0)2922 940959; Wales.REC2@wales.nhs.uk), ref: 25/WA/0302 |
| Health condition(s) or problem(s) studied | Management of pleural infection |
| Intervention | This study is a prospective, multi-centre randomised controlled study with internal pilot and embedded antibiotic pharmacokinetic (PK) study of adult patients hospitalised with pleural infection. Patients are randomised to therapeutic thoracentesis (TT) or chest tube insertion as the initial pleural procedure to drain the infected pleural fluid. At screening, patients will have informed consent and demographics taken and eligibility assessment performed. At baseline, patients will be randomised to either therapeutic thoracentesis or chest tube insertion as the initial pleural procedure to drain the infected pleural fluid. They will then have their medical, medication, Radiology results (chest x-ray and pleural ultrasound), RAPID score (a baseline severity score) and lab tests recorded. At baseline, patients will also have their intervention performed, Patient reported outcomes, EQ-5D and VAS questionnaires completed and if consented to, Blood and Pleural fluid sample collected. Following screening, baseline assessment and randomisation there will be trial visits at Day 7 and Day 90. The focus of these will be the collection of clinical information to inform primary and secondary outcomes. Whilst patients are having pleural procedures (either with TT or chest tube), pleural fluid and or samples, may be collected and stored for antibiotic analysis. This will be optional for both study sites and patients. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Length of initial hospital stay in days measured using patient records at Day 90 measured using patient records |
| Key secondary outcome measure(s) |
1. Proportion of patients readmitted to hospital within 30 days following discharge, measured using patient records |
| Completion date | 31/12/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 172 |
| Key inclusion criteria | Hospitalised adult patients with a clinical presentation consistent with pleural infection AND requiring initial pleural fluid drainage based on one of the following parameters: 1. Pleural fluid pH <=7.2 2. Pleural LDH >=900 3. Pleural fluid glucose <=4.0 mmol/L (or 72 mg/dl) 4. Pleural septations/loculation on ultrasound 5. Evidence of pleural infection on CT 6. Pleural effusion occupying >50% of hemithorax on chest radiograph 7. Age >= 16 years |
| Key exclusion criteria | 1. Excessive bleeding risk in view of the treating clinician 2. Previous pneumonectomy, chest tube/drain, indwelling catheter or recent surgery on side of current pleural infection 3. RAPID score (if calculable) >5 (indicating a high risk of mortality within 3 months) 4. Enrolment onto another study where the burden on the participant will be too high if they are enrolled onto both. Or if the enrolment onto both would compromise one or both of the study’s objectives. To be decided on a case-by-case basis. |
| Date of first enrolment | 02/03/2026 |
| Date of final enrolment | 31/12/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Aberford Road
Wakefield
WF1 4DG
England
Holdforth Road
Hartlepool
TS24 9AH
England
Stoke-on-trent
ST4 6QG
England
Odstock Road
Salisbury
SP2 8BJ
England
Sheffield
S1 3FG
England
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the study chief investigator, Dr David Arnold (david.arnold@nbt.nhs.uk) following the publication of the trial findings. |
Editorial Notes
18/12/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
