Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair

This study is investigating if a special way of managing a breathing machine, called a lung volume optimisation maneuver, can help children who have had heart surgery. When babies and children with certain heart conditions have surgery, they often need a machine to help them breathe. Sometimes this machine needs careful adjustments to ensure their lungs are working as best they can, which in turn can help their heart recover. We're comparing this special method with standard care to see if it helps their heart and lungs recover faster, reduces the time they need the breathing machine, and improves their overall health after the operation. We hope to make their recovery smoother and healthier.

At a glance

Status

Not yet recruiting

Phase

PHASE1, PHASE2

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

01 Sep 2026

Estimated completion

31 Dec 2028

Congenital Heart Disease Cardiopulmonary Bypass Mechanical Ventilation Peep Titration in Lung Protective Ventilation Positive End-expiratory Pressure (PEEP)Lung Volume Lung Mechanics Children Hemodynamic Changes Cardiac Surgery

What is this study about?

When children have heart operations, especially for certain conditions, they often need a special machine called a ventilator to help them breathe. During and after these operations, the lungs can sometimes get a bit squashed or not expand fully. This can make it harder for the heart to work as well as it should. Think of it like trying to pump water through a hose that's a bit kinked – it's much harder for the pump.

This study is looking at a specific technique to help with this. It's called a 'lung volume optimisation maneuver' and it involves carefully adjusting the pressure settings on the breathing machine. The idea is to gently inflate the lungs to their best size, which can then make it easier for the heart to pump blood around the body. We're hopeful this could lead to quicker recovery times and better overall health for children after their surgery.

The main goal is to see if this careful adjustment of the breathing machine helps the heart and lungs recover better. We'll also be looking at whether children spend less time on the breathing machine, have steadier blood pressure, and need less medication to support their heart after the operation. This research is important because it could lead to better ways of caring for children during a critical time in their recovery.

Key takeaways

This study helps children recovering from heart surgery.
It tests a special way to use breathing machines to improve heart and lung function.
Children will receive either the new technique or standard care.
The aim is to help them recover faster and better.
Participation is voluntary and closely monitored.

Who may be eligible?

This study is for babies and children up to 18 years old who have certain heart problems and are having surgery that requires a heart-lung bypass machine. This machine temporarily takes over the work of the heart and lungs during the operation.

However, some children won't be able to join the study. This includes those with a very specific type of heart condition where they only have one main pumping chamber (called 'single ventricle physiology'). Also, children who are already on advanced life support like ECMO or VAD, or those born very prematurely (before 36 weeks of pregnancy), cannot take part.

We also can't include children who have a long-term lung problem, or if the breathing tube in their windpipe isn't fitting well. Finally, we need the full agreement and understanding from the child's parents or guardians for them to be part of 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.

Is my child aged between newborn and 18 years old?
Does my child have a congenital heart condition requiring surgery?
Is my child's surgery going to use a heart-lung bypass machine?
Does my child NOT have a single-ventricle heart condition?
Is my child NOT on advanced life support like ECMO?
Is my child NOT born very prematurely (before 36 weeks)?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will either receive the special lung adjustment technique or the standard breathing machine care, just like other children having similar surgery. Both groups will be closely monitored by the medical team. The special technique involves careful adjustments to their breathing machine over a short period after their surgery. We will be checking their heart and lung function very often during this time, just as we would for any child recovering from heart surgery. There are no extra hospital visits or special medications beyond what is normally needed for their care. The study largely involves observing and measuring how your child responds to their breathing support as part of their routine post-operative care.

Potential risks and benefits

Participating in research always has potential benefits and risks. The potential benefit of this study is that the special breathing machine adjustments might help your child's heart and lungs recover better, leading to a smoother recovery. However, it's also possible that there could be no difference compared to standard care, or even rarely, unforeseen effects. All children in the study will be very closely monitored by the medical team to ensure their safety and well-being. Please remember that taking part is entirely voluntary, and you have the right to withdraw your child from the study at any time without it affecting their medical care.

Locations (1)

German Heart Center of the Charité
Verified postcode
Berlin, Germany

Common questions

What is 'heart-lung bypass'?

It's a machine that temporarily takes over the work of your child's heart and lungs during surgery, allowing the surgeons to operate on a still heart.

What is a 'breathing machine'?

It's a common medical device that helps your child breathe after surgery, especially when their body needs to focus on healing.

What does 'optimizing lung volume' mean?

It means carefully adjusting the breathing machine to ensure your child's lungs are expanded to the best possible size, helping them work efficiently.

Will my child feel anything different?

Your child will likely be sedated (asleep) during the time of these adjustments, so they won't feel anything. Their comfort and safety are always our priority.

What is 'standard care'?

This is the usual, established medical treatment that children with similar conditions receive, based on current best practices.

How to find out more

Jan C Clausen, MD

jan.clausen@posteo.de 00493045932800 Official trial record

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