RecruitingNAINTERVENTIONAL

Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation

This study is for adults and children in intensive care who are on a breathing machine. Researchers want to understand how a patient's own breathing efforts affect their lungs and a muscle called the diaphragm, which helps us breathe. They will use a small, soft tube placed in the nose (like a feeding tube) to measure breathing efforts. They will also use ultrasound scans to look at the diaphragm and lungs. This will be done daily for up to 8 days. The main idea is to see if making a small breathing effort while on the machine can keep the diaphragm working well and not harm the lungs. This study aims to find better ways to use breathing machines to protect patients' bodies.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Antwerp

Enrolment target

150

Start

21 Sep 2022

Estimated completion

01 Dec 2025

Respiratory Muscles Respiration, Artificial Respiratory Function Tests

What is this study about?

This study is looking at adults and children who are in intensive care and need help breathing from a machine, often called a ventilator. When someone is on a breathing machine, their body still tries to breathe on its own. This study wants to understand how much effort a patient makes to breathe and what effect this has on their lungs and a very important muscle called the diaphragm. The diaphragm is a large muscle under the lungs that plays a big role in breathing.

The main goal is to figure out if making a gentle breathing effort while on the ventilator can help keep the diaphragm strong and healthy, without causing any problems for the lungs. By understanding this better, doctors might be able to adjust how breathing machines work in a way that is kinder to the patient's body.

To do this, the research team will use a few special tools. They will place a very thin, soft tube through the nose – similar to a feeding tube – to measure the pressure changes as someone breathes. This helps them understand how much effort the patient is making. They will also use ultrasound, which is a safe way to look inside the body (like scans used during pregnancy), to check on the diaphragm and lungs. These measurements will be taken every day for up to eight days.

Key takeaways

This study helps us understand how breathing machines affect lungs and the diaphragm.
It aims to find out if gentle breathing efforts can protect these organs.
Measurements involve a small tube and safe ultrasound scans.
The study takes place in intensive care for up to 8 days.
It will not change standard medical care for patients.

Who may be eligible?

This study is open to most adults and children in intensive care who are at least 29 days old and weigh more than 3 kilograms (about 6.6 pounds). To be included, patients must need a breathing machine and be expected to stay on it for more than two days.

However, there are some reasons why someone might not be able to join. For example, if they or their parents don't want to take part. Also, if they've been on a breathing machine very recently (within the last two weeks) before this current illness, they might not be suitable.

Some medical conditions would also prevent participation, such as a known problem with the diaphragm (the main breathing muscle), or if there's a medical reason why the tiny tube, which measures breathing effort, cannot be safely put in place.

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/is your child in intensive care?
Are you/is your child on a breathing machine?
Are you/is your child at least 29 days old?
Do you/does your child weigh more than 3 kg (about 6.6 pounds)?
Is it expected that you/your child will need the breathing machine for more than 2 days?
Have you been told about any existing problems with the diaphragm?

Answer every question to see your result.

What does participation involve?

If you or your child takes part in this study, you won't need to take any extra medication. The main thing involved is that the research team will take some measurements each day for up to 8 days. These measurements include:

* **Placing a very thin, soft tube:** A small tube will be gently placed through the nose, down the throat, to sit near the stomach. This is similar to a feeding tube and helps measure breathing effort. It will stay in place during the daily measurements and will be taken out when the study measurements are complete or earlier if needed. * **Ultrasound scans:** The team will use a safe and painless ultrasound machine (like those used to look at babies during pregnancy) to check the diaphragm and lungs. These are quick scans that just involve placing a small device on the chest or tummy.

There are no extra visits to the hospital involved, as all procedures will be done at the patient's bedside while they are in intensive care. The total duration for taking measurements from each patient will be a maximum of 8 days.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this study, potential benefits include helping doctors better understand how breathing machines affect patients, which could lead to improved care for future patients. There are no direct personal benefits of treatment for those taking part, as this study is observational (meaning it measures things without changing typical care). The main potential risk comes from the placement of the small tube, which can sometimes cause mild discomfort or, very rarely, a minor injury. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your or your child's medical care.

Locations (3)

Antwerp University Hospital (UZA)
Verified postcode
Edegem, Belgium· Recruiting
University Hospital Leuven (UZL)
Verified postcode
Leuven, Belgium· Recruiting
The Hospital for Sick Children (SickKids)
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'breathing machine'?

A breathing machine, or ventilator, is a medical device that helps patients breathe when they are very unwell, by delivering air into their lungs.

What is the diaphragm?

The diaphragm is a large, flat muscle located at the bottom of our chest, right under the lungs. It's the main muscle we use to breathe.

Will this study change my or my child's medical care?

No, this is an observational study, which means it measures things without changing the medical care or treatment you or your child is already receiving.

Is the small tube painful?

The tube is very thin and soft, and while its placement might cause some temporary discomfort, it's generally well-tolerated. It's similar to tubes often used for feeding.

How long will the study measurements take each day?

The daily measurements, including the ultrasound and readings from the tube, are usually done quite quickly at the bedside in intensive care.

How to find out more

Vertongen

icu-research@uza.be +323 821 44 04 Official trial record

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