Not yet recruitingNAINTERVENTIONAL

Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients

This study is looking at how two different ways of using a breathing machine, called ventilation, affect adults with severe burns. The two methods are called Flow-Controlled Ventilation (FCV) and Pressure-Controlled Ventilation (PCV). Researchers want to find out if FCV is a 'kinder' way to help patients breathe, meaning it puts less stress on their lungs. This is important because breathing machines, while life-saving, can sometimes damage the lungs. The study will mainly compare how much 'mechanical power' (a measure of lung stress) each method uses. Patients will receive one of these ventilation methods for up to 70 hours, and researchers will also monitor other organ functions.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital Bergmannsheil Bochum

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Jun 2028

Burn Injury Inhalational Injury Pulmonary Complications Ventilator-induced Lung Injury (VILI)

What is this study about?

When someone has severe burns, especially if their lungs are affected, they often need a breathing machine to help them. These machines, called ventilators, deliver air to the lungs. While they are crucial for saving lives, sometimes the way they deliver air can put too much stress on the lungs and lead to further problems. This study aims to find a safer and gentler way to support burn patients who need help breathing.

We are comparing two main methods of using these breathing machines. One is a newer approach called Flow-Controlled Ventilation (FCV), and the other is a more common method called Pressure-Controlled Ventilation (PCV). Think of it like driving a car: with FCV, we have very precise control over how the air flows in and out, adjusting to each person uniquely. With PCV, we set a certain amount of air for each breath, and the machine adjusts the pressure to deliver it.

The main goal of this study is to see if FCV can reduce the 'mechanical power' applied to the lungs. Mechanical power is a way to measure the stress the breathing machine puts on the lungs. If we can lower this stress, we hope to prevent lung damage and other breathing problems that can happen when someone is on a ventilator for a long time after a severe burn. We will carefully monitor patients on either FCV or PCV for up to 70 hours and also check how their other organs are working.

Key takeaways

This study compares two ways a breathing machine can help burn patients.
It aims to find a gentler method (FCV) to reduce stress on the lungs.
Participants will be assigned to either FCV or standard PCV for up to 70 hours.
The main goal is to measure lung stress ('mechanical power').
It's for adults (18-80) with severe burns needing breathing support.

Who may be eligible?

This study is looking for adults aged 18 to 80 years old who weigh at least 40 kg and have severe burns. You would be considered if you need a breathing machine shortly after arriving at the burn intensive care unit (within 24 hours of starting breathing support or within 48 hours of admission). Also, it’s expected that you will need this breathing machine for at least another 24 hours.

There are some reasons why you might not be able to join. For example, if you are already involved in another medical study or if you have a severe skin condition like Stevens-Johnson syndrome or toxic epidermal necrolysis. If you, or your next of kin, are unable to provide consent, you also cannot participate.

Before taking part, a central line (a special IV for medication and blood tests) and a monitor for your blood pressure would need to be in place as part of your standard intensive care treatment. This study requires your or your family's permission 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 to 80 years old?
Do you weigh at least 40 kg?
Do you need a breathing machine for a severe burn injury?
Did you start needing the breathing machine within 24 hours of admission or within 48 hours if admitted to the burn unit?
Is it expected that you will need the breathing machine for at least another 24 hours?
Are you NOT currently part of another medical trial?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, you will be randomly assigned to one of two groups: either the FCV breathing machine setting or the PCV setting. This decision is made by chance, like flipping a coin. You will receive this specific breathing support for up to 70 hours. During this time, the research team will closely monitor your breathing machine settings and continuously collect information on how your lungs are responding. They will also keep track of how your other organs are functioning, like your heart and other body systems. There are no additional hospital visits or medication specifically for this study beyond what is already part of your standard intensive care for severe burns. The study concludes after this monitoring period.

Potential risks and benefits

The potential benefit of participating in this study is that you might receive a ventilation method (FCV) that could be gentler on your lungs, potentially leading to fewer complications compared to the standard approach. However, there is no guarantee of direct benefit. The risks involved are generally those associated with being on a breathing machine in an intensive care setting, which are part of your usual care for severe burns. The study primarily involves adjusting how the breathing machine is set, not adding new procedures. You or your legal representative have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

BG University Hospital Bergmannsheil, Ruhr University Bochum
Verified postcode
Bochum, Germany

Common questions

What is a 'breathing machine'?

A breathing machine, or ventilator, is a medical device that helps you breathe when you cannot do so effectively on your own. It pushes air into your lungs.

What is 'mechanical power'?

Mechanical power is a measure of how much force and energy the breathing machine is using on your lungs. Higher mechanical power can put more stress on the lungs.

What are severe burn injuries?

Severe burn injuries are serious burns that cover a large area of the body or are very deep, often requiring intensive medical care.

Will I know which breathing method I'm getting?

Because this is a study, you will be assigned to a group by chance. The medical team will know which setting you are on to provide the necessary care.

Can I leave the study if I change my mind?

Yes, you or your legal representative can decide to leave the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Simon Becker, Jun.-Prof. Dr. med., M.D.

simon.becker@rub.de +49 234 - 302 6917 Official trial record

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