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Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients

This study is investigating a different way of helping people breathe during heart surgery, specifically an operation called tricuspid clipping. Doctors usually use machines that push air into your lungs (positive pressure ventilation). In this study, they are looking at a method called negative pressure ventilation, which works by gently pulling on your chest to help you breathe, similar to how you breathe naturally. Researchers want to see if using this negative pressure method can help the right side of your heart function better during the surgery. They will compare heart function and breathing information when using both standard breathing support and this new negative pressure method.

At a glance

Status
Not yet recruiting
Sponsor
Karlsburg Hospital
Enrolment target
30
Start
01 Sep 2024
Estimated completion
01 Sep 2025

What is this study about?

This study is focusing on patients who are having a particular type of heart surgery called tricuspid clipping. This operation helps treat a problem with one of the heart's valves. During any major surgery, especially heart surgery, patients are usually put to sleep with general anaesthetic and a machine helps them breathe. The standard way these machines work is by pushing air into your lungs, which is called positive pressure ventilation.

However, this study is exploring a different method of breathing support called negative pressure ventilation. Instead of pushing air in, a special chest piece gently creates a vacuum around your chest, which helps your lungs expand and take in air, more like how you breathe naturally. The doctors want to find out if this different way of breathing support, the negative pressure method, could be better for the right side of your heart during the surgery. Sometimes the standard breathing machines can put a strain on the right side of the heart, and this study aims to see if negative pressure ventilation can reduce that strain.

They will collect information about your breathing, how your heart is pumping, and detailed ultrasound pictures of your heart, first while you are on the standard breathing machine and then again when using the negative pressure breathing support. The goal is to see if there are any improvements in how your heart, particularly the right side, is working when supported by negative pressure ventilation. This research could help doctors understand better ways to care for patients during complex heart surgeries in the future.

Key takeaways

  • Study looks at different breathing support during heart surgery.
  • Compares standard breathing machine to 'negative pressure' method.
  • Aims to see if new method helps the right side of the heart.
  • All procedures happen while you are asleep for surgery.
  • Could help improve future care for heart patients.

Who may be eligible?

To be able to take part in this study, you must be a patient who is already scheduled to have a tricuspid clipping operation.

There are some reasons why you might not be able to join the study. If your breathing or blood pressure is very unstable, or if the special chest piece for the negative pressure ventilation cannot be fitted properly to you, then you won't be able to participate. Also, if there isn't a trained study doctor available at the time of your surgery, you won't be able to be included.

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.

  1. Am I scheduled for a tricuspid clipping operation?
  2. Do I have stable breathing and blood pressure?
  3. Can a special chest piece be fitted comfortably to me?
  4. Is a trained study doctor available at the time of my surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part, it will all happen during your planned tricuspid clipping surgery while you are under general anaesthetic. You won't feel anything during the study procedures. After you've had your anaesthetic and the usual monitoring equipment is in place (like lines in your arm and neck, and a special ultrasound probe), a chest piece for the negative pressure breathing support will be placed on your chest, but it won't be turned on yet. First, doctors will collect information about your breathing, heart function, and detailed ultrasound pictures while you are on the standard breathing machine. Then, the negative pressure breathing support will be turned on, and the standard breathing machine will be adjusted. The same measurements will be taken again. Once these measurements are complete, the chest piece will be removed, and your surgery will continue as normal. There are no extra visits or follow-up appointments specifically for this study, and the total duration of the study part is quite short, happening entirely within your planned surgery time.

Potential risks and benefits

The main benefit of taking part is that the information gathered could help improve how patients are cared for during heart surgery in the future. As the negative pressure breathing support is applied while you are under general anaesthetic, any potential discomfort should not be directly felt. All procedures will be monitored closely by medical staff. You have the right to withdraw from the study at any time, even once it has started, without affecting your medical care.

Locations (1)

  • Klinikum Karlsburg, Klinik für Anästhesiologie
    Verified postcode
    Karlsburg, Germany

Common questions

What is 'tricuspid clipping'?

It's a type of heart surgery that helps fix a problem with one of the heart's valves, called the tricuspid valve.

What is negative pressure ventilation?

It's a way of helping you breathe where a special piece gently pulls on your chest to help your lungs take in air, similar to how you breathe naturally.

Will I be awake during the study?

No, you will be under general anaesthetic for your surgery, so you won't be awake or feel anything during the study procedures.

Are there any extra appointments needed for this study?

No, all parts of the study happen during your planned heart surgery.

Can I change my mind about taking part?

Yes, you can decide not to take part or withdraw from the study at any time, and it won't affect your medical care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Effects of Negative Pressure Ventilation on Right Ventricula…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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