Not yet recruitingNAINTERVENTIONAL

Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life

Doctors are exploring a new way to care for patients with a specific type of collapsed lung, called a primary spontaneous pneumothorax, that appears without an injury. Usually, these patients stay in the hospital for treatment. This study compares treating some patients at home with the usual hospital stay. The main goal is to see if recovering at home helps patients feel better and improves their quality of life. They will also look at whether home treatment is a more efficient and practical way to manage this condition for the healthcare system. The study involves a number of hospitals and will track how patients feel after treatment and then again six months later.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Strasbourg, France

Enrolment target

386

Start

01 Dec 2025

Estimated completion

01 Jul 2030

Primary Spontaneous Pneumothorax Quality of Life Ambulatory Care Chest Tube

What is this study about?

When you have a collapsed lung, called a pneumothorax, it means that air has leaked into the space between your lung and chest wall, causing part or all of the lung to collapse. A 'primary spontaneous pneumothorax' means it happened without an obvious injury or other lung disease. Typically, this has meant a stay in the hospital for treatment, which can involve placing a tube into the chest to help re-inflate the lung.

This study is looking at a different approach for certain patients with this condition: managing their recovery at home, also known as 'ambulatory care.' The aim is to see if treating suitable patients at home, rather than in the hospital, can improve how they feel overall and lead to a better quality of life. Researchers will compare this home-based care with the standard hospital treatment to understand the differences.

The study also wants to find out if managing the condition at home is a more efficient and practical way to provide care in the long run. By involving several hospitals, the study hopes to gather enough information to determine if this new approach could become a common and beneficial way to help many more patients in the future.

Key takeaways

This study compares hospital care vs. home care for a collapsed lung.
It focuses on a specific type of collapsed lung (primary spontaneous pneumothorax).
The main goal is to see if home care improves patients' quality of life.
Participants will be aged 18-50 years and have a specific type of collapsed lung.
Questionnaires will track how participants feel over six months.

Who may be eligible?

This study is looking for people aged between 18 and 50 years old who have just had their first primary spontaneous pneumothorax, which is a specific type of collapsed lung that occurs without injury. It needs to be a larger type of collapsed lung, as defined by special guidelines, and diagnosed by a chest X-ray or CT scan. You'll need to be living less than an hour away from the hospital and have someone who can stay with you or help you for the first two days after you leave the hospital.

To take part, you must be able to understand what the study involves and be happy to sign a consent form. You also need to have internet access to complete online questionnaires and have some form of health insurance. You can't be suffering from a small collapsed lung, a very severe collapsed lung that makes it hard to breathe, or if you need emergency oxygen. If your collapsed lung was caused by an injury, if you have other lung conditions, or if you have a collapsed lung on both sides, this study is not for you.

Also, you won't be able to join if you live alone without support, if you're pregnant or breastfeeding, or if you're already taking part in another clinical trial. If you have other serious health problems that would make home treatment risky, or if you find it difficult to understand instructions, you won't be eligible.

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.

Are you between 18 and 50 years old?
Is this your first time having a collapsed lung (primary spontaneous pneumothorax)?
Do you live less than an hour from the hospital?
Do you have someone who can support you at home for the first 48 hours?
Do you have internet access to complete online forms?
Are you able to understand and sign consent forms?

Answer every question to see your result.

What does participation involve?

If you join this study, your doctor will decide if you are suitable for home management of your collapsed lung or if you'll receive standard hospital care. Regardless of which group you are in, some assessments will be the same. You will complete questionnaires about your quality of life: once when you first join, again after any treatment like a chest drain, and then a final time six months later. These questionnaires will likely be completed online. You will need to make sure you have internet access to do this. The total duration of your participation, including follow-up, will be six months. There are no study medications involved.

Potential risks and benefits

Participating in this study might offer the benefit of receiving your care at home, which could be more comfortable and convenient for some patients, potentially leading to a better recovery experience and improved quality of life. However, home treatment also carries risks, as you won't have constant medical supervision immediately available. There’s a risk that your condition could worsen, or complications might arise that would require prompt hospital attention. Standard hospital care, while meaning a stay away from home, provides immediate access to medical staff and facilities. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

CHRU de Besançon - Hôpital Jean Minjoz
Verified postcode
Besançon, France
Hôpital Pellegrin - CHU de Bordeaux
Verified postcode
Bordeaux, France
CHU de Grenoble - Hôpital Michallon
Verified postcode
La Tronche, France
Hôpital Saint Louis - AP-HP
Verified postcode
Paris, France
Hôpital Universitaire Pitié Salpétrière AP-HP
Verified postcode
Paris, France
Hôpital de la Milétrie - CHU de Poitiers
Verified postcode
Poitiers, France
Hôpitaux Universitaires de Strasbourg
Verified postcode
Strasbourg, France

Common questions

What is a primary spontaneous pneumothorax?

It's a type of collapsed lung that happens suddenly without an injury or other lung condition. It means air has leaked into the space around your lung.

What does 'ambulatory management' mean?

It means you might be able to receive your care and recover at home instead of staying in the hospital.

Will I have to go to the hospital if I'm in the home care group?

You'll still need initial assessment and potentially a procedure like a chest drain at the hospital, but much of your recovery and monitoring might happen at home.

What is 'quality of life' in this study?

It refers to how you feel physically and mentally, and how your condition impacts your daily activities and general well-being.

How long will the study last for me?

Your participation, including completing questionnaires, will last for about six months from the time you join.

How to find out more

Sabrina GARNIER-KEPKA, MD

sabrina.garnier-kepka@chru-strasbourg.fr 3 69 55 13 35 Official trial record

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