A study testing different treatments to help stop air leaks from collapsed lung
| ISRCTN | ISRCTN15099654 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15099654 |
| IRAS number | 348034 |
| Secondary identifying numbers | CPMS 65614, NIHR303204 |
- Submission date
- 08/07/2025
- Registration date
- 24/07/2025
- Last edited
- 09/09/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Sometimes, air can get stuck between the lung and chest wall, causing the lung to collapse. This is called a pneumothorax. When this happens to people who already have lung problems, it’s called “secondary spontaneous pneumothorax” (SSP). Normally, doctors treat this problem by putting a drain in your chest to help remove the air. The drain can stay for about a week or longer.
Sometimes, the air keeps leaking for more than 2 days. This is called a "persistent air leak" (PAL), and we don’t always know the best way to treat it. Right now, doctors often wait to see if the air leak stops on its own, which can take a while—sometimes even weeks.
There are a few other treatments doctors use, but we don’t know which one works best or which order they should be given. This is a feasibility study that will help us to work out whether it is possible to design and conduct a larger study that will answer those question.
Who can participate?
Patients with either a lung disease or over 50 years old with a history of smoking, who are in hospital because they have a problem where air is trapped between their lung and chest wall, causing their lung to collapse, and the lung is still leaking air after 2 days.
What does the study involve?
In the study, half of the participants will initially get treatment using SUCTION to help remove air, and the other half will get the USUAL CARE without suction. If the air leak still doesn’t stop after 3 more days, the participant will be given one of three different treatments:
Endobronchial Valves: Special valves are put inside your lung to block the air leak. This is done with a thin tube that goes into your mouth.
Autologous Blood Patch: Doctors take a little of your blood from your arm and put it into your chest to help stop the air leak.
Usual Care: This means just waiting for the lung to heal on its own.
If the air leak hasn’t stopped 10 days after the participant started the study, the doctor may decide to try one of the other treatment options.
Participants will be asked to complete two short questionnaires after you have provided your consent, on day 7 of the study and at your day 90 visit.
What are the possible benefits and risks of participating?
There may not be any direct benefits for each participant. But the study will help doctors learn more about how to treat people with this lung problem, which can help future patients.
All trial treatments, suction, endobronchial valves, autologous blood patch, as well as no additional treatments are all standard treatments that are used in the NHS. They all have some evidence to support their use, however none of the evidence is strong enough to make strong recommendations that they should be used for every patient with SSP.
Where is the study run from?
The study is being organised and run by Bristol Academic Respiratory Unit on behalf of North Bristol NHS Trust (UK)
When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in September 2025 and the study will recruit over 24 months. Once enrolled in the study, a participant will be involved for 90 days.
Who is funding the study?
This study is funded by the National Institute for Health and Care Research (UK)
Who is the main contact?
Dr Steven Walker, steven.walker@bristol.ac.uk
Contact information
Public, Scientific, Principal Investigator
Academic Respiratory Unit
University of Bristol
Level 2, Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 117 414 8114 |
|---|---|
| steven.walker@bristol.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Platform Randomised feasibility trial Of Suction, Endobronchial valves and Autologous blood patch on air-Leak |
| Study acronym | PRO-SEAL |
| Study objectives | To test whether is it feasible and acceptable to conduct a multi-center randomised platform trial to evaluate the use of interventions for persistent air leak in patients with pneumothorax secondary to underlying lung disease |
| Ethics approval(s) |
Approved 22/07/2025, London - Central Research Ethics Committee (3rd Floor, 3 Piccadilly Place, London Road, Manchester, M1 3BN, United Kingdom; +44 207 104 8061; londoncentral.rec@hra.nhs.uk), ref: 25/LO/0483 |
| Health condition(s) or problem(s) studied | Persistent air-leak |
| Intervention | Autologous blood patch (ABP), Patients randomised to ABP will have 1mg/kg of blood aspirated by appropriately trained clinician. This blood will be then instilled via the drain into the pleural space. Endobronchial valve (EBV), Participants assigned Endobronchial valve (EBVs) will be referred for EBV placements. This will inserted via bronchoscopy. This can be performed under conscious sedation or general anaesthetic (GA), depending on local protocols. This will be done by an appropriately trained clinician. Thoracic suction , Patients randomised to Thoracic suction will have suction applied to their chest drainage system by a staff nurse. The suction would continue as long as drain remains in place. Follow up for 90 days. Eligible patients will be randomised (1:1:1:1:1:1) through a randomisation server. A member of the trial team will randomise patients as soon as eligibility has been confirmed and consent obtained. Randomisation will use a commercial secure, internet-based system, Sealed Envelope. A minimisation algorithm with random element will be implemented, balancing on underlying lung disease (COPD/non-COPD) and recruiting site. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The proportion of the total number of patients who are eligible for trial entry who accept randomisation measured using patient records at end of study |
| Secondary outcome measures | Measured using patient records (unless noted otherwise): 1. Duration of air-leak in first 90 days 2. Duration of chest drain in-situ in first 90 days 3. Proportion of patients with air-leak cessation 72hours after 2nd intervention 4. Proportion of patients meeting inclusion and exclusion criteria approached by trial team 5. Proportion of patients randomised who receive the first allocated intervention 6. Proportion of patients randomised who receive the second allocated intervention 7. Proportion of patients randomised who complete trial follow-up 8. Pain (using visual analogue score, VAS) and breathlessness (VAS) measured post-intervention, day 7 and at day 90 post-randomisation (±7 days) 9. Patient-reported health status (EQ-5D-5L) measured post-intervention (within 24 hours), day 5 and day 90 post-randomisation (±14 days) 10. To assess patient views and experiences of interventions and study design 11. To assess clinician views of interventions and study design 12. Total number of pleural procedures in first 90 days 13. Length of initial hospital stay (LOHS) in first 90 days 14. Surgical referral and acceptance rates in first 90 days 15. Mortality rates in first 90 days 16. Serious adverse rates in first 90 days |
| Overall study start date | 01/03/2025 |
| Completion date | 25/08/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. A secondary spontaneous pneumothorax, defined as a pneumothorax occurring in a patient with known underlying or suspected lung disease or >50 years of age with a smoking history 2. Ongoing air-leak ≥48hours after insertion of intercostal drain |
| Key exclusion criteria | 1. They have bilateral pneumothoraces 2. They have a traumatic or iatrogenic pneumothorax 3. They are < 18 years of age 4. Inmate of the prison systems of England and Wales, Scotland or Northern Ireland 5. Patient lacking capacity to consent for themselves |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 22/09/2027 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
London
SE1 7EH
United Kingdom
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
London
SW17 0QT
United Kingdom
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Hospital/treatment centre
Southmead Hospital, Southmead Road, Westbury-on-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 1174148114 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository, the University of Bristol’s data repository, data.bris, where the dataset will be issued a DOI, which will then be cited in the body of the research publication. Data will only be available for 5 years after the trial has concluded and after publication of the main study results. No identifiable data will be shared, it will be fully anonymised. Data sharing will be in line with the University of Bristol’s Open Research policy. Anonymised individual patient data will be made available for secondary research, conditional on assurance from the secondary researcher that the proposed use of the data is compliant with the University of Bristol’s Open Research policy regarding information security, information governance, ethical requirements, and a data access agreement has been signed by their institution. |
Editorial Notes
09/09/2025: Ethics approval details and study participant centre added. The date of first enrolment was changed from 22/09/2025 to 01/11/2025.
08/07/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
