Not yet recruitingNAINTERVENTIONAL

Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements (MM) as a Marker of Inspiratory Effort in the Spontaneously Breathing Intensive Care Patient

This research is investigating a new, simpler approach to measure breathing effort in patients in intensive care. Currently, this involves placing a thin tube into the food pipe (oesophagus), which can be uncomfortable. This study aims to see if observing small movements of the jaw could provide the same valuable information, without the need for an invasive tube. The main goal is to compare jaw movement analysis with the current standard method. This could help doctors better understand when patients are ready to breathe on their own after being on a ventilator. Finding an easier way to check breathing effort could lead to better care and quicker recovery for patients needing help with breathing.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

Start

01 Feb 2026

Estimated completion

01 Apr 2027

Acute Respiratory Failure (ARF)Intensive Care Unit (ICU) Patients Invasive Mechanical Ventilation

What is this study about?

When people are very unwell and in intensive care, especially if they have serious breathing problems, doctors often use a machine called a ventilator to help them breathe. As patients get better, the medical team tries to gradually reduce the ventilator's support so the patient can start breathing on their own again. This process is often called 'weaning' from the ventilator.

An important part of weaning is knowing how much effort a patient is putting into each breath. If they're working too hard, it can be harmful to their lungs and make it harder to come off the ventilator. Currently, the most accurate way to measure this breathing effort involves putting a special tube down into the food pipe (oesophagus). While very useful, this method can be uncomfortable for the patient and isn't something that can be done all the time.

This study is looking for a simpler and more comfortable way to measure breathing effort. Researchers are going to track tiny movements of the patient's jaw while they breathe. The idea is that these jaw movements might give doctors a clear picture of how much effort the patient is using to breathe, just like the tube in the food pipe does. If this new method works well, it could mean doctors have a much easier way to monitor patients, helping them make better decisions about when it's safe to reduce breathing support and when to encourage patients to breathe more on their own, potentially leading to a smoother recovery.

Key takeaways

This study is looking for an easier way to check breathing effort in intensive care.
It compares jaw movement tracking with the current tube-based method.
The new method aims to be more comfortable and non-invasive.
If successful, it could help doctors make better decisions about breathing support.
No new medicines are involved in this study.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently in intensive care because of serious breathing problems. You must have been on a breathing machine (ventilator) for more than 24 hours. To join, your breathing and oxygen levels need to be stable, and you should be able to cough effectively. You also need to be reasonably awake and not on strong ongoing sedation or high doses of certain blood pressure medications.

The study is particularly interested in patients who might have a higher chance of needing help with their breathing for longer, for example, if you are over 65, have certain heart conditions (like a weak heart muscle or a history of heart attacks), or specific lung conditions such as COPD or severe obesity.

Unfortunately, you wouldn't be able to join if you have certain medical conditions that make it unsafe to place a tube in your nose or mouth, or if you have uncontrollable sickness, a collapsed lung that hasn't been treated, or severe head or face injuries. Pregnant or breastfeeding women, or people who are not able to give consent for themselves due to legal reasons, also cannot take part.

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 in intensive care for breathing problems?
Have you been on a breathing machine for over 24 hours?
Are you generally awake and not deeply sedated?
Do you have certain heart or lung conditions, or are you over 65 (which might increase your risk of needing breathing support for longer)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve two main recording periods. During these times, special sensors will be used to monitor your jaw movements while you are breathing. This will involve placing small, harmless sensors on your face near your jaw. At the same time, the medical team will also carry out the standard method of measuring breathing effort, which involves a thin tube in your food pipe (oesophagus). This will allow them to compare the two methods directly.

These recording periods will happen while you are being weaned from the ventilator (meaning doctors are gradually reducing the machine's support) and again within 48 hours after you have successfully come off the ventilator. The study doesn't involve any new medications, and all other medical care will continue as usual. The total time you are involved in the special monitoring will not be long, and the rest of your care will be unaffected.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information doctors learn could help improve care for other intensive care patients in the future by finding an easier way to check breathing effort. There are very few risks involved beyond those of standard care; the jaw movement sensors are non-invasive and painless. You will still have the standard oesophageal pressure measurement as part of the comparison, which is a routine, though sometimes uncomfortable, procedure. You are free to withdraw from the study at any time without giving a reason, and this will not affect the quality of your medical care.

Locations (1)

University Hospital Grenoble
Verified postcode
Grenoble, France

Common questions

What is the main goal of this study?

The main goal is to find out if watching jaw movements can be a simple, comfortable way to measure how hard patients are breathing in intensive care, instead of using an uncomfortable tube.

Will I have to take any new medicines?

No, this study does not involve any new medicines. Your medical care will continue as normal.

How long will I be involved in the study?

The special monitoring will happen during two short periods: while you are being taken off the breathing machine, and again within two days after you've come off it completely.

Will taking part affect my treatment?

No, taking part will not change the treatment you receive. Your doctors will continue to give you the best medical care.

What if I change my mind about participating?

You can decide to stop taking part in the study at any time, and it will not affect your medical care in any way.

How to find out more

Florian SIGAUD

fsigaud@chu-grenoble.fr 0476768076 Official trial record

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