RecruitingNAINTERVENTIONAL

ARMSTRONG - Air entRainMent vS sTandard tReatment in nOn-expandable luNG

The ARMSTRONG study explores a new method for draining fluid from around the lungs in patients with a condition called 'non-expandable lung' (NEL). NEL means the lung can't fully expand after fluid removal, often causing pain and making drainage difficult. This trial investigates if introducing a small, controlled amount of air into the chest during the drainage procedure can reduce pain, improve patient comfort, and lead to more effective fluid removal. It uses a simple, low-cost technique with standard equipment. The study compares this new air entrainment method with the usual drainage approach to see if it helps patients experience less pain, fewer repeated procedures, and better overall satisfaction during this common treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

14 Apr 2025

Estimated completion

30 Oct 2026

Non-expandable Lung Trapped Lung Pleural Effusion Malignant Pleural Effusions (Mpe)

What is this study about?

When you have too much fluid around your lungs, known as a pleural effusion, your doctor might need to drain it. For some people, especially those with cancer or other long-term lung conditions, the lung doesn't fully expand again after the fluid is removed. This is called a 'non-expandable lung' (NEL). This can cause pain, makes the drainage difficult, and sometimes means you need to have the procedure done many times.

Faced with a non-expandable lung, draining the fluid can create a strong vacuum effect in the chest. This vacuum often leads to significant pain, dizziness, and means the drainage has to stop before all the fluid is removed. Currently, there aren't many good ways to deal with this, beyond just stopping the procedure or giving pain relief that doesn't solve the main problem.

This study is looking at a simple, safe, and inexpensive new idea: gently letting a small amount of air into the chest during the drainage. This can be done using a standard piece of equipment called a 3-way tap. The idea is that by letting a little air in, it reduces that vacuum effect, which could ease the pain, allow more fluid to be drained, and potentially reduce the number of times you need the procedure. We want to see if this new approach makes a real difference to patients' comfort and the success of their drainage.

Key takeaways

This study evaluates a new treatment for non-expandable lung (NEL) during fluid drainage.
It tests if gently introducing air into the chest can reduce pain and improve drainage.
The method uses simple, standard equipment and aims to improve patient comfort.
Participants will be assigned by chance to either the new method or standard care.
The study focuses on pain levels, drainage success, and patient satisfaction.
Taking part involves no extra appointments beyond your routine drainage procedures.

Who may be eligible?

This study is looking for adults aged 18 or over who have had a build-up of fluid around their lungs, which doctors suspect or have confirmed as a 'non-expandable lung'. You would need to be scheduled for fluid drainage as part of your usual care and be able to understand information and give consent in English.

However, you wouldn't be able to join if you've already had a procedure called pleurodesis (which seals the lung lining), have an active infection, or have severe pain (scoring 5 or more out of 10) even before the procedure starts. Also, if you need a specific type of permanent drainage tube called an IPC, or have other medical reasons not to have lung drainage or air introduced, you wouldn't be eligible. Lastly, if you can't understand or consent in English, you wouldn't be able to participate.

Quick self-check

Are you 18 years old or older?
Do you have a problem with fluid around your lung and suspected 'non-expandable lung'?
Are you scheduled to have fluid drained from your lung?
Can you understand information and give consent in English?
Have you NOT had a pleurodesis procedure before?
Do you NOT have severe pain (5/10 or higher) before the procedure starts?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you choose to take part, you'll be assigned by chance (like flipping a coin, but weighted) to one of two groups. Two out of three people will be in the group that tries the new air introduction method, and one out of three will have the standard drainage. During your regular fluid drainage procedure, if you're in the new method group, a small amount of air might be gently let into your chest up to five times, depending on whether you feel pain and what the doctor decides.

Your pain levels will be regularly assessed during the procedure using a simple scale. We will also collect information about how much fluid is drained, how often you need drainage, and any side effects. After the procedure, you'll be asked about your satisfaction with the process. You won't have any extra hospital visits just for the study; all assessments will happen during your routine drainage appointments. The study team will be blinded, meaning they won't know which group you're in, to ensure results are unbiased.

Potential risks and benefits

Taking part might mean you experience less pain during your drainage procedure and potentially have more fluid removed effectively, possibly reducing the number of times you need the procedure. The air introduction method uses standard, safe equipment. However, as with any medical procedure, there are always some risks, though this study aims to reduce problems rather than create new ones. While the risks are expected to be very low, potential side effects related to any drainage procedure, like infection or small air leaks, would be carefully monitored. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Addenbrooke's Hospital
Cambridge, United Kingdom· Recruiting

Common questions

What is a 'non-expandable lung'?

It's when your lung can't fully get back to its normal size after fluid has been drained from around it, often due to a long-term illness or cancer.

What is 'air entrainment'?

It's a medical term for gently letting a small, controlled amount of air into the space around your lung during fluid drainage, to make the process more comfortable.

Will I know if I'm getting the new treatment or standard care?

No, you won't know which group you're in. This helps us get an unbiased understanding of whether the new method truly works better.

How will my pain be measured?

You'll be asked to rate your pain on a simple scale from 0 (no pain) to 10 (worst pain imaginable) during the drainage.

Does this mean I'll have more air in my chest?

A small amount of air is temporarily introduced to balance pressures during drainage. The aim is to reduce negative pressure, which may prevent complications like pain and aid drainage, not to trap air permanently.

How to find out more

Emilia M SWIETLIK, MD PhD

e.swietlik@nhs.net +447736750560 Official trial record

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