Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomized Clinical Trial of Inhaled Sedation with Sevoflurane in Critically Ill Patients at Risk of Developing the Acute Respiratory Distress Syndrome

This research is a Phase III clinical trial for very sick patients in the intensive care unit (ICU) who are at risk of developing Acute Respiratory Distress Syndrome (ARDS), a severe lung condition. The study is comparing different types of sedation to see which might be best. Patients will receive either a medicine that is breathed in (like an anaesthetic gas) or standard sedation given through a drip. The main goal is to see if one type of sedation helps improve how well the lungs work over time. Researchers will also look at how many people develop ARDS, how long patients need to be on a ventilator, how long they stay in ICU, their overall survival, and if they experience confusion while in ICU. The aim is to find safer and more effective ways to care for critically ill patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

CHU Gabriel-Montpied

Enrolment target

Start

10 Oct 2024

Patients in ICU with risks of Acute Respiratory Distress Syndrome

What is this study about?

This study is a clinical trial focusing on critically ill patients in the Intensive Care Unit (ICU) who are at risk of developing a serious breathing problem called Acute Respiratory Distress Syndrome (ARDS). ARDS happens when the lungs become very inflamed and fill with fluid, making it hard to breathe and get enough oxygen. Patients in ICU often need medication to keep them calm and comfortable, and sometimes to help them tolerate a breathing machine.

The trial is comparing different types of sedation. Some patients will receive a sedative medication that they breathe in, like an anaesthetic gas. Other patients will receive standard sedative medications usually given through a drip. The main purpose is to see if using an inhaled sedative might help improve how well a patient's lungs are working over time, compared to traditional methods.

Researchers will be carefully monitoring many aspects of a patient's health. This includes checking if patients develop ARDS, how many days they can breathe without a ventilator, how long they stay in the ICU, and their overall survival. They will also look at things like confusion experienced in ICU and other health measures. By comparing these outcomes, the study hopes to find the best way to sedate very sick patients, potentially leading to better recovery and fewer complications.

Key takeaways

This study compares inhaled sedation with standard sedation for critically ill patients.
It targets patients in ICU at risk of a severe lung condition called ARDS.
The main goal is to see if one type of sedation helps improve lung function and recovery.
Patients are already in ICU; no extra visits are required beyond usual care.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adult patients who are 18 years old or older. Both men and women can take part.

To be eligible, patients must already be in the intensive care unit (ICU) and be considered at risk of developing a serious lung condition called Acute Respiratory Distress Syndrome (ARDS).

Other detailed medical criteria would need to be met, which the doctors involved in the study would check carefully to ensure it's safe and appropriate for a patient to participate.

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?
Are you currently an intensive care unit (ICU) patient?
Are you considered by doctors to be at risk of developing ARDS (a serious lung condition)?
Are you comfortable with the idea of potentially receiving an inhaled sedative or a standard sedative through a drip?

Answer every question to see your result.

What does participation involve?

If a patient is suitable for this study, they would be in the intensive care unit and receive one of the study's sedative treatments. This could be an inhaled sedative (breathed in) or a standard sedative given through a drip, alongside other usual ICU care. The treatments would continue for as long as needed during their time in ICU, as determined by their doctors.

Throughout their participation, doctors and nurses would constantly monitor their health, including how their lungs are working, their need for breathing support, and their general condition. There wouldn't be extra hospital visits or assessments beyond the usual ICU care, but specific blood tests or imaging might be done as part of the study's monitoring. The total duration of participation would depend on how long the patient needs sedation and stays in the ICU.

Potential risks and benefits

Patients in this study are already very ill, and the study aims to see if one type of sedation could lead to better outcomes. Potential benefits might include improved lung function, shorter time on a breathing machine, or a quicker recovery from their illness, though these are not guaranteed. As with any medical treatment, there are potential risks associated with all sedative medications, which your doctor would discuss with you. These could include side effects specific to the medications or complications related to being critically ill. All care would be closely monitored by medical staff. Patients are always free to withdraw from the study at any time without affecting their medical care.

Locations (1)

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

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Unverified
France

Common questions

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where the lungs become very inflamed and fill with fluid, making it difficult to breathe and get enough oxygen.

What is sedation?

Sedation is medicine given to make you calm, relaxed, or sleepy, especially when you are very unwell or need medical procedures. In ICU, it helps patients tolerate treatments and allows their bodies to heal.

What does a 'Phase III' trial mean?

A Phase III trial means this is one of the final stages of testing a treatment. It compares a new treatment with existing ones in a larger group of patients to confirm if it is effective and safe.

Will I know which treatment I'm getting?

In a 'randomized' trial like this, patients are put into groups by chance. Neither you nor your doctors may know which specific sedative you are receiving, to ensure the results are fair.

Will participating in this study change my routine ICU care?

No, your essential ICU care will not change. This study is looking at different types of sedation within the usual care you would receive as a critically ill patient.