RecruitingNAINTERVENTIONAL

Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System

This study aims to find the best way to drain fluid from around the lungs (called pleural effusion), which can be a problem for people with advanced cancer. A special tube, called an indwelling pleural catheter (IPC), is used to help. Researchers want to compare two methods: using natural gravity or using a gentle suction. They're particularly interested in how these different methods affect a patient's comfort, pain levels, and overall quality of life. Currently, there's no clear best way to drain fluid, and some people experience discomfort. This study hopes to provide clear answers to help doctors choose the most helpful method for patients in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Johns Hopkins University

Enrolment target

200

Start

31 Jan 2019

Estimated completion

31 Dec 2026

Pleural Effusion

What is this study about?

When someone has advanced cancer, fluid can sometimes build up around their lungs. This is called a pleural effusion and it can make it difficult to breathe and uncomfortable. To help with this, doctors can insert a small, soft tube called an indwelling pleural catheter (IPC). This tube stays in place and allows the fluid to be drained regularly, which can greatly improve symptoms and quality of life. While the IPC itself is a good solution, there's still some debate about the best way to drain the fluid through it.

This study wants to look closely at two different ways of draining the fluid: using natural gravity (where the fluid simply flows out) or using a gentle suction (where a small pump helps draw the fluid out). Doctors think that the way the fluid is drained might affect how a patient feels, especially regarding any chest pain or discomfort. For example, a slower, more natural drainage might be gentler. By comparing these two methods, the researchers hope to understand which one makes patients feel better and improves their overall quality of life.

Your participation would help doctors understand if one drainage method is more comfortable and effective than the other. This information is really important because it could lead to better care and improved comfort for many patients with similar conditions in the future.

Key takeaways

Compares two ways to drain fluid from the lungs.
Aims to improve patient comfort and quality of life.
Uses a commonly fitted drainage tube (IPC).
Involves questionnaires and a drainage diary, no new medications.
Randomly assigned to gravity or suction drainage.
Your standard medical care for cancer will continue as usual.

Who may be eligible?

To be part of this study, you would typically need to have fluid around your lung (a pleural effusion) that is causing symptoms and is linked to cancer. Doctors would need to be confident that this fluid is indeed causing your breathing difficulties and that inserting the drainage tube will help.

You would also need to be aged 18 or over and planning to have the drainage tube inserted within the next 10 days. The fluid must be visible enough on an ultrasound scan to allow for the safe placement of the tube.

There are also some reasons why you might not be able to join. For example, if you've had a recent chest operation or injury causing ongoing pain, if you are pregnant or breastfeeding, or if you already have certain other conditions like a serious infection in your lung area or severe bleeding problems. This study also isn't suitable if you have a very short life expectancy (less than 30 days) or if you are unable to understand English or attend follow-up appointments.

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.

Do you have a fluid build-up around your lung (pleural effusion) related to cancer?
Are you 18 years old or older?
Are you planning to have a drainage tube (IPC) inserted soon?
Are you able to speak, read, and understand English?
Are you able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have the drainage tube (IPC) placed as routinely done by your hospital team. You would then be randomly assigned, like flipping a coin, to one of two groups: either draining your fluid using gravity or using a gentle suction. You won't know which method you'll be using until after you've joined the study.

Throughout the study, you'll receive your usual cancer care. The study itself won't change your medical treatment for cancer. Your involvement will mainly include filling out questionnaires about your quality of life and comfort levels, and keeping a diary of your fluid drainage. You will have follow-up appointments at two weeks, four weeks, and twelve weeks after the tube is put in, and then as needed according to your regular clinical care. These appointments will involve reviewing your drainage diary and checking in on your well-being.

Potential risks and benefits

Participating in this study might help us learn more about the best way to manage fluid around the lungs, which could benefit future patients. The study itself adds very little to the usual care you would receive, as it primarily involves questionnaires. There are no additional medical procedures or treatments beyond what your doctor would normally recommend. As with any medical study, there's always a small chance of unforeseen discomfort or inconvenience from filling out forms. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Northwest Community Healthcare
Verified postcode
Arlington Heights, United States· Recruiting
Johns Hopkins Hospital
Verified postcode
Baltimore, United States· Recruiting
Medical University of South Carolina
Verified postcode
Charleston, United States· Recruiting
Vanderbilt University Medical Center
Verified postcode
Nashville, United States· Recruiting
Swedish Medical Center
Verified postcode
Seattle, United States· Recruiting
University of Oxford
Verified postcode
Oxford, United Kingdom· Not yet recruiting

Common questions

What is a pleural effusion?

A pleural effusion is when fluid builds up between your lung and the inside of your chest wall, which can make it hard to breathe.

What is an IPC?

An IPC (indwelling pleural catheter) is a thin, flexible tube inserted into your chest to help drain fluid from around your lung over time.

Will I know which drainage method I'm using?

You will be told whether you are in the gravity-based or suction-based drainage group after you've joined the study.

How long will I be in the study?

You'll have specific follow-up appointments at 2, 4, and 12 weeks after your tube is inserted, and then your involvement will continue as long as your regular clinical care requires.

Will my regular cancer treatment be affected?

No, your usual cancer treatment will continue as planned and will not be changed by taking part in this study.

How to find out more

IP Research

ipresearch@jhmi.edu 410-502-2533 Official trial record

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