A trial to investigate whether pleuroscopy can be used to treat pleural infection
| ISRCTN | ISRCTN98460319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98460319 |
| Protocol serial number | 33928 |
| Sponsor | Southmead Hospital |
| Funder | Academy of Medical Sciences |
- Submission date
- 26/06/2017
- Registration date
- 03/07/2017
- Last edited
- 30/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
A pleural effusion is a collection of fluid between the lung and the chest wall. It commonly occurs as a result of pneumonia and can cause significant breathlessness. In about 10% of cases, this fluid can itself go on to become infected, which increases the chances of someone becoming unwell enough to need surgery, or even dying. It is important that the fluid is drained away completely soon after someone is diagnosed with pleural infection. This is usually done by inserting a small chest tube between the ribs and allowing the fluid to drain out over time. This treatment typically requires many days in hospital but is generally low risk. Medical thoracoscopy is a common technique used to diagnose and drain effusions, although it is not routinely used for pleural infection in the UK as it tends to be reserved for those who are suspected of having cancer. It involves inserting a small camera between the ribs into the fluid and can be done under local anaesthetic. The procedure is very safe but carries a slightly higher risk of complications than standard chest tube insertion. However, the main benefit of the procedure is that it can allow a patient to spend less time in hospital because the chest is drained completely all at once. The aim of this study is to evaluate whether hospitals are able to safely offer medical thoracoscopy to patients with pleural infection
Who can participate?
Adults aged 18 and older who have pleural effusion.
What does the study involve?
Eligible participants are asked to answer questions about their background and previous health. Participants are randomly allocated to one of two groups that determined how their infected fluid is drained. Those in the first group receive the standard treatment, whereby a small tube is inserted between the ribs under local anaesthetic and the fluid is drained. Those in the second group receive the study treatment, which involves placing a small camera between the ribs to inspect and drain the fluid away. Participants are discharged after a few days in hospital. During their stay, participants receive standard care and treatment, but are also asked to perform simple breathing tests and answer some questions about their symptoms and quality of life. Participants are followed up at their local hospital by the trial team after one month and three months, when further information about their recovery and symptoms is gathered to see how the treatment affects patients themselves, and whether it is effective at reducing patients’ time in hospital or their need for surgery. About half of the patients enrolled will also be invited to take part in a more in-depth interview about their experiences in the trial.
What are the possible benefits and risks of participating?
There are no notable benefits with participating however participants are reimbursed for travel expenses. There are no notable risks however, there is normally some risk associated with any medical procedure and this will be discussed in detail with participants depending which treatment they are asked to undergo.
Where is the study run from?
This study takes place at Southmead Hospital (UK) and takes place in seven other hospitals in the UK.
When is the study starting and how long is it expected to run for?
July 2016 to January 2019 (updated 03/07/2019, previously: July 2018)
Who is funding the study?
Academy of Medical Sciences (UK)
Who is the main contact?
1. Dr Rahul Bhatnagar
Rahul.Bhatnagar@bristol.ac.uk
2. Dr Emma Keenan
Emma.Keenan@nbt.nhs.uk
Contact information
Public
Academic Respiratory Unit
Learning and Research Building, Level 2
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0003-3906-1997 |
|---|---|
| Phone | +44 7887 997420 |
| Rahul.Bhatnagar@bristol.ac.uk |
Public
Respiratory Research Unit
Clinical Research Centre
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 117 414 8114 |
|---|---|
| Emma.Keenan@nbt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment, Surgery |
| Secondary study design | Randomised controlled trial |
| Scientific title | Studying Pleuroscopy in Routine Pleural Infection Treatment Trial |
| Study acronym | SPIRIT |
| Study objectives | Randomising patients with pleural infection to undergo either medical pleuroscopy or standard chest drain insertion is feasible and acceptable. |
| Ethics approval(s) | Yorkshire & The Humber - Sheffield Research Ethics Committee, 12/04/2017, ref: 17/YH/0074 |
| Health condition(s) or problem(s) studied | Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other acute lower respiratory infections |
| Intervention | Those who agree to enrolled are first asked to answer questions about their background and previous health. Eligible participants are randomised in a 1:1 ratio using an online (computer-based) system. Patients are randomised to receive one of two standard procedures. The intervention arm (medical pleuroscopy) entails a procedure lasting approximately 45 minutes. The control arm (chest drain insertion) consists of a procedure lasting approximately 15 minutes. Intervention arm: Patients will undergo medical pleuroscopy on either the same or next day as they are diagnosed as needing a pleural intervention. They will have the procedure under light conscious sedation and local anaesthetic. Control arm: Patients will undergo routine chest drain insertion on either the same or the next day as they are diagnosed as needing a pleural intervention. The procedure will be performed under local anaesthetic. Patients with pleural infection can usually be discharged home after a few days in hospital. During their stay, participants receive standard care and treatment, but are also asked to perform simple breathing tests and answer some questions about their symptoms and quality of life. Participants are followed up at their local hospital by the trial team after one month and three months, when further information about their recovery and symptoms is gathered. About half of the patients enrolled will also be invited to take part in a more in-depth interview about their experiences in the trial. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The feasibility of screening and enrolling patients into the study, and delivering the trial protocol is measured using the proportion of pre-screen failures, screen failures, and allocation failures compared to the total numbers of patients pre-screened, screened, and randomised (respectively). |
| Key secondary outcome measure(s) |
1. Duration of stay due to pleural infection is measured by the number of nights in hospital between enrolment and being recorded as medically fit for discharge |
| Completion date | 31/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 12 |
| Key inclusion criteria | 1. Pleural effusion due primarily to suspected pleural infection requiring chest tube drainage, defined as an effusion, in the appropriate clinical context, with one or more of the following characteristics: 1.1. Fluid pH ≤7.20 or visually contains pus 1.2. Pleural fluid glucose ≤3.4 mmol/L 1.3. Positive bacterial or mycobacterial culture 1.4. Positive gram stain or stain for acid-fast bacilli 2. Clinical team are able to perform a medical thoracoscopy, if allocated, on either the same or the next day as the effusion is diagnosed as requiring drainage 3. Clinical team are able to deliver the post-procedure trial schedule as detailed in the protocol 4. Patient is willing to consider trial entry and receive information sheet |
| Key exclusion criteria | 1. Any contraindication, in the opinion of the trial team or lead clinician, to 1.1. Medical thoracoscopy performed under conscious sedation 1.2. Chest drain insertion 1.3. Trial involvement 2. Patient is unable to provide informed consent 3. Thoracic imaging demonstrating septation or loculation to a degree whereby medical management alone would be inappropriate 4. Maximum pleural fluid depth of ≤2cm on thoracic ultrasound 5. Ongoing sepsis requiring haemodynamic support beyond basic fluid resuscitation 6. Previous thoracic surgery on the side of the effusion 7. Age <18 8. Pregnancy or lactation 9. Expected survival ≤3 months |
| Date of first enrolment | 01/08/2017 |
| Date of final enrolment | 30/04/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
England
Great Western Road
Gloucester
GL1 3NN
England
Headley Way
Headington
Oxford
OX3 9DU
England
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
Westminster Bridge Road
London
SE1 7EH
England
1345 Govan Road
Glasgow
G51 4TF
Scotland
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at North Bristol NHS Trust. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/12/2025 | 30/12/2025 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3.1 | 06/04/2018 | 24/08/2022 | No | No |
Additional files
- ISRCTN98460319_Protocol_v3.1_06Apr18.pdf
- Protocol file
Editorial Notes
30/12/2025: Publication reference added.
24/08/2022: The protocol (not peer reviewed) has been uploaded as an additional file.
14/02/2020: The intention to publish date has been changed from 31/08/2019 to 31/08/2020.
20/01/2020: One of the public contact's email addresses has been updated and the plain English summary changed accordingly.
03/07/2019: The following changes were made to the trial record:
1. The overall end date was changed from 31/07/2018 to 31/01/2019.
2. The total final enrolment was added.
3. The plain English summary was updated to reflect these changes.
26/10/2017: Internal review.
