RecruitingOBSERVATIONAL

Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients

This study is about breathlessness (dyspnea) in very unwell patients in intensive care, especially those who are overweight. When patients are ready to breathe on their own after being on a breathing machine, they go through a process called "weaning." Breathlessness can make this process harder. We want to find out how common breathlessness is during weaning, what causes it, and what effect it has on overweight patients compared to others. Our goal is to improve care for these patients and help them breathe independently more successfully.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

21 Mar 2025

Estimated completion

01 May 2027

Obesity Obesity With Complications Weaning From Mechanical Ventilation in Care Unit Dyspnea

What is this study about?

Imagine you're really unwell in intensive care and need help breathing from a machine. At some point, your doctors will gradually try to help you breathe on your own again. This process is called 'weaning' from the ventilator. Sometimes, during this time, people feel very breathless, which can be quite upsetting and scary. This study is focused on this feeling of breathlessness, medically known as 'dyspnea'.

We know that feeling breathless can be a big problem, not just physically but also emotionally, causing a lot of distress. While doctors pay a lot of attention to pain, breathlessness in this situation hasn't always received as much focus. We also know that patients who are overweight might face extra challenges when coming off a breathing machine because their bodies work a bit differently. This can make them more likely to feel breathless and have difficulties during weaning.

So, this study aims to understand breathlessness better in these patients. We'll be comparing overweight patients with those who are not, looking at how often breathlessness happens, what might be causing it, and what consequences it has, such as making it harder to come off the breathing machine. By understanding these things better, we hope to find ways to make the weaning process smoother and less distressing for all patients.

Key takeaways

The study investigates breathlessness in critically ill patients coming off breathing machines.
It specifically looks at how breathlessness affects overweight patients.
No new medicines or treatments are given; it's an observational study.
The goal is to improve understanding and future care for patients in intensive care.
Participation is voluntary and won't affect your medical care.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) who has been on a breathing machine for at least two days in intensive care. Your doctors need to believe you're ready to start trying to breathe on your own again, which means your main illness has improved, you can cough, your oxygen levels are good, and your heart and blood pressure are stable.

We are particularly interested in patients who are overweight (with a BMI over 30). It's important that you, or your family if you can't decide, are happy for you to take part. Also, you shouldn't have certain conditions that would make it difficult to assess your breathlessness, like serious memory problems or certain nervous system illnesses.

Unfortunately, if you are pregnant or breastfeeding, under 18, or have certain severe medical conditions that prevent weaning, you wouldn't be able to join. We also wouldn't include you if you have difficulties communicating your feelings, which would make it hard to accurately measure your breathlessness for the study.

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 18 years old or older?
Have you been on a breathing machine in intensive care for at least 2 days?
Do your doctors think you're ready to start trying to breathe on your own?
Are you, or your family, comfortable with you taking part in a study that observes your breathing?
Are you considered overweight (BMI over 30)?

Answer every question to see your result.

What does participation involve?

This study does not involve any new medications or procedures. You will receive the usual care for patients in intensive care. If you join, the study team will simply be observing and collecting information about your breathing and feelings of breathlessness during the normal process of weaning from the ventilator. They will use standard tools to assess how breathless you feel and how well your breathing is doing. This will happen during the time you would already be trying to breathe independently. There are no additional visits required beyond your existing hospital stay.

Potential risks and benefits

There are no significant direct risks involved in this study as it only involves observation and information gathering during your usual care; no new treatments are given. The main benefit is to help us understand breathlessness better, which could lead to improved care for patients like you in the future. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Service de Médecine Intensive-Réanimation Hôpital Tenon, AP-HP
Verified postcode
Paris, France· Recruiting

Common questions

What is 'dyspnea'?

Dyspnea is the medical term for feeling breathless or short of breath.

What does 'weaning from mechanical ventilation' mean?

It's the process where doctors gradually help you come off the breathing machine and breathe on your own again.

Will I get any different treatment if I join?

No, you will receive the same medical care as any other patient in your situation. This study only involves observation.

Why are you focusing on overweight patients?

Overweight patients can sometimes have unique challenges with breathing, so we want to understand how breathlessness affects them specifically during weaning.

Can I change my mind about participating?

Yes, you can decide to stop participating at any time without it affecting your care.

How to find out more

Alexandra BEURTON, Doctor

alexandra.beurton@aphp.fr 00 33 6 23 08 64 88 Official trial record

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