RecruitingOBSERVATIONAL

Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery

This study is about how big operations on your chest, like for lung or stomach cancer, can sometimes lead to complications afterwards. These problems can make you stay in hospital longer and slow down your recovery. Doctors think that changes in your heart rate and breathing patterns, which they call 'variability,' might give clues about who is more likely to have problems after surgery. The study will test a new way of checking this heart and breathing variability before surgery. They want to see if this new test can help predict complications better than current methods. The goal is to use this information to create personalised care plans that could help prevent problems and make surgery safer for you.

At a glance

Status

Recruiting

Sponsor

Ottawa Hospital Research Institute

Enrolment target

130

Start

01 Jul 2025

Estimated completion

01 Jul 2026

Thoracic Cancer Complication,Postoperative

What is this study about?

Big operations on your chest, often for conditions like lung or stomach cancer, can sometimes lead to unexpected problems or 'complications' afterwards. These complications can mean you need to stay in hospital longer and might make your recovery more difficult. Doctors are always looking for better ways to predict who might be at higher risk of these problems so they can try to prevent them.

This study is exploring a new idea: that natural changes in your heart rate and breathing patterns might hold clues. When you're healthy, your body's systems, like your heart and lungs, have a lot of natural rhythm and change – doctors call this 'variability.' When someone is unwell or stressed, this natural variability can decrease. The researchers want to see if checking these heart and breathing patterns before surgery can help predict if you're likely to have problems afterwards.

If this new test works, it could help doctors understand your individual risk before surgery. This understanding could then allow them to tailor your care more specifically, potentially preventing complications and making your journey through and after surgery much smoother and safer. They are also comparing this new test with existing methods to see if it adds valuable information.

Key takeaways

Aims to predict surgery complications using heart and breathing patterns.
Focuses on big chest operations for certain cancers or tumours.
Hopes to make surgery safer by personalising care.
Involves a new, non-invasive pre-operative test.
No direct personal benefit, but helps future patients.

Who may be eligible?

This study is looking for adults aged 18 or older who are scheduled to have a major operation on their chest. This includes surgeries for lung, food pipe (oesophagus), or stomach cancer, or for a growth in the part of your chest between your lungs (mediastinal tumour). Examples of these large operations include removing a section or whole lung, or parts of your food pipe or stomach.

However, some people won't be able to join. You can't take part if your surgery is needed urgently (like in an emergency), or if you already have certain heart rhythm problems, such as atrial fibrillation, or if you rely on a pacemaker. Also, if you can't complete the special heart and lung tests before surgery, or if you are pregnant, you won't be able 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 years old or older?
Are you having a major chest operation for lung, food pipe, stomach cancer, or a chest tumour?
Do you currently have a pacemaker or specific heart rhythm problems like atrial fibrillation?
Are you able to take part in simple heart and breathing tests before surgery?
Are you currently pregnant?

Answer every question to see your result.

What does participation involve?

As this is a study assessing a new pre-operative test, it does not involve any medication. If you take part, you would undergo a special heart and lung variability assessment before your surgery. This assessment involves measuring your heart rate and breathing patterns. The study team would then follow your recovery after surgery to see if you experience any complications. The overall duration of your participation would cover the period from your pre-operative assessment through to your recovery from surgery, as part of your usual care.

Potential risks and benefits

The main benefit of taking part is contributing to research that could make surgery safer for future patients. There are no direct benefits to you personally from the assessment itself. The special heart and lung tests are not expected to have any significant risks, as they involve non-invasive measurements of your body's natural rhythms. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is 'variability' in simple terms?

It's about the natural changes in things like your heart rate and breathing. A healthy body often shows more natural changes, while an unwell body might show less.

Will this study change my surgery plan?

The goal of this study is to gather information. It's not expected to change your surgery plan directly, but the insights gained could lead to safer surgery methods in the future.

What kind of 'major thoracic surgery' are they talking about?

This refers to big operations on your chest, such as removing part or all of a lung, stomach, or food pipe (oesophagus) due to cancer or tumours.

Is the heart and lung test painful?

No, the tests are not painful. They involve simply measuring your heart and breathing patterns, similar to routine check-ups but with more detailed equipment.

What are 'postoperative adverse events'?

These are simply complications or problems that can happen after surgery, like infections, breathing difficulties, or issues with wound healing.

How to find out more

Andrew JE Seely, MD,PhD,FRSCS

aseely@toh.ca 713-737-8899 Official trial record

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