RecruitingInterventional

Treating people with a lung collapse (pneumothorax) without inserting a needle into the chest. Is it safe and effective?

A primary spontaneous pneumothorax happens when air suddenly leaks into the chest space, causing a lung to collapse without any injury or known illness. The usual NHS treatment is to insert a needle or plastic tube into the chest to drain the trapped air. While this helps the lung re-inflate, it often means spending several days in hospital and carries risks like pain and infection. The CONSEPT trial is exploring whether larger lung collapses can be managed through observation alone. Patients aged 16 to 50 who take part will either receive standard chest drainage or be monitored closely for a few hours and allowed home if stable. Researchers will track both groups for one year to see how quickly people recover, how they feel, and whether the lung problem returns. This could help future patients safely avoid invasive chest tubes.

At a glance

Status

Recruiting

Sponsor

North Bristol NHS Trust

Enrolment target

164

Start

01 Apr 2023

Estimated completion

28 Feb 2027

Primary spontaneous pneumothorax

What is this study about?

A pneumothorax, commonly called a collapsed lung, happens when air leaks out of the lung and collects in the space between the lung and the chest wall. When this happens without an obvious injury or previous lung illness, doctors call it a 'primary spontaneous pneumothorax'. Around 3,000 people in the UK are admitted to hospital with this condition every year, often causing sudden chest pain and shortness of breath.

Currently, if the lung collapse is large or causing clear symptoms, doctors usually place a needle or plastic tube into the chest to remove the trapped air. While this treatment can help the lung expand again quickly, it usually requires a hospital stay of up to a week. Having a tube placed in the chest can also be uncomfortable and carries small risks, including infection or bleeding.

Doctors already know that smaller lung collapses can heal naturally as the body absorbs the trapped air over time. The CONSEPT trial was set up to find out if this 'wait and watch' approach is also safe and effective for larger collapses. By comparing close observation against standard chest drainage, researchers hope to discover whether many patients can safely skip invasive procedures and recover comfortably at home.

This study matters because its findings could modernise how hospitals treat collapsed lungs. If observation proves just as safe and reliable as inserting chest tubes, future patients could spend less time in hospital, experience less pain, and get back to their normal daily lives much sooner.

Key takeaways

The CONSEPT trial investigates whether a collapsed lung can heal naturally without a chest drain.
It is open to people aged 16 to 50 who have had a sudden, large lung collapse.
Participants are randomly assigned to either receive standard drainage or close monitoring.
Those in the observation group may be able to go home within hours if stable.
Follow-up lasts for one year to monitor healing and check for repeat collapses.

Who may be eligible?

This trial is open to people aged between 16 and 50 who come to hospital with a sudden, large lung collapse that causes symptoms. To take part, your medical team must feel that standard treatment would normally involve inserting a chest drain or needle to remove the air.

You cannot take part if you have a known underlying lung illness, such as severe lung disease. However, people with mild, well-controlled asthma who use standard inhalers may still be able to join. You will also not be eligible if both lungs are collapsed at the same time, if your blood oxygen levels are low (below 92% on room air), or if you are pregnant.

Finally, the study cannot include anyone with a 'tension pneumothorax', which is a rare emergency where trapped air quickly builds up high pressure inside the chest and requires immediate medical treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am between 16 and 50 years old.
I have been diagnosed in hospital with a sudden collapsed lung (pneumothorax).
I do not have any serious underlying lung diseases (mild, well-controlled asthma is fine).
Only one of my lungs has collapsed, not both.
I am not pregnant.

Answer every question to see your result.

What does participation involve?

If you agree to take part, a computer system will place you into one of two groups by chance. One group receives standard hospital treatment, meaning a doctor inserts a needle or chest tube to drain the air. The other group will be closely observed by the medical team for a few hours without having a tube inserted. If you are in the observation group and your breathing is stable and comfortable, you can go home to rest.

All participants will have regular check-ups to monitor their recovery. You will be asked about your symptoms, your pain levels, and how quickly you return to daily activities. You may have a small number of chest X-rays to check on the lung, including one that might be extra to standard care. Your health and whether the lung collapse comes back will be tracked over the course of 12 months.

Potential risks and benefits

Taking part might not benefit you personally, as doctors do not yet know which approach is better. However, your involvement will help improve care for future patients. If you receive standard treatment, a chest drain carries small risks of pain, bleeding, or infection. If you are in the observation group, you avoid an invasive procedure, but your lung might take longer to heal, and you may still end up needing a drain later if your symptoms worsen. The trial involves X-rays, which carry a tiny radiation risk, though this is kept as low as possible. You are entirely free to withdraw from the study at any time without your regular NHS care being affected.

Locations (16)

North Bristol NHS Trust
City only
Bristol, England
Oxford University Hospitals
City only
Oxford, England
Blackpool Victoria Hospital
Approximate
Blackpool, England
Addenbrookes
Approximate
Cambridge, England
Royal Infirmary of Edinburgh at Little France
City only
Lothian, Scotland
University Hospital Birmingham
Unverified
Birmingham, England
Queensview Medical Centre
Unverified
Northampton, England
Derriford Hospital
Unverified
Plymouth, England
Royal Gwent Hospital
Unverified
Newport, Wales
Royal United Hospital
Unverified
Bath, England
Royal Stoke University Hospital
Unverified
Stoke-on-trent, England
Royal Berkshire Hospital
Unverified
Reading, England

Common questions

What is a primary spontaneous pneumothorax?

It is a medical term for a lung collapse that happens out of the blue in someone who does not have an existing lung disease or a chest injury.

Can I choose which treatment I receive?

No. To make the trial fair and accurate, a computer allocates you to either standard chest drainage or observation entirely by chance.

What happens if my breathing gets worse at home?

You will be given clear guidance on what warning signs to look out for and who to contact. If your condition worsens, the medical team can place a chest drain at any point to keep you safe.

How long does the study last?

You will be followed up by the research team for up to one year to monitor your recovery and check whether the lung collapse happens again.

Will taking part affect the quality of my NHS care?

No. Your safety is always the top priority. Whether you join or decide to leave the trial, you will receive the highest standard of hospital care.

How to find out more

Lucy Hamilton

consept-trial@bristol.ac.uk +44 117 455 4092 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.