Active not recruitingOBSERVATIONAL

Predicting Neuromuscular Recovery in Surgical Patients Using Machine Learning

The PINES project is researching how to improve the use of muscle relaxants during surgery. Sometimes, after an operation where these drugs are used, patients can still feel a bit weak in their muscles, which is called residual paralysis. This study uses artificial intelligence (AI) to create a model that can accurately guess how long these muscle relaxants will work for each person. This means doctors could get real-time advice on when and how much medicine to use, helping patients recover more fully and reducing common problems after surgery, like breathing difficulties. The study will also compare the AI's prediction to what experienced anaesthetists expect, to see how well it works.

At a glance

Status

Active not recruiting

Sponsor

University Hospital Ulm

Enrolment target

240,000

Start

01 Mar 2024

Estimated completion

01 Jan 2027

Residual Paralysis, Post Anesthesia Postoperative Complications Neuromuscular Blockade Quantitative Neuromuscular Monitoring

What is this study about?

When you have an operation under general anaesthesia, doctors often use special medicines called muscle relaxants. These drugs temporarily stop your muscles from moving, making it easier for the surgeon to operate. However, it can be tricky to predict exactly how long these medicines will act in each person. Even with modern monitoring, some patients might still have weak muscles – known as residual paralysis – when they wake up, which can sometimes lead to breathing problems or other complications after surgery.

This research project, called PINES, aims to make this process much safer and more precise. It's using advanced computer programs, often called Artificial Intelligence (AI) or machine learning, to build a smart system. This system will learn from lots of patient data to accurately predict how long a muscle relaxant will affect someone. Imagine a tool that could tell your anaesthetist exactly when you'll be fully strong again, allowing them to adjust your medication for the best possible outcome.

The main goal is to create a model that can tell us: 1. When your muscles will be fully recovered. 2. The perfect time and dose for muscle relaxants during your surgery. 3. How strong your muscles will be at the very end of the operation.

To do this, the researchers will first analyse lots of existing medical records. Then, they will run a small study where they compare the AI's predictions with what experienced anaesthetists think will happen. This will help them see if the AI system is truly accurate and helpful in real-life situations, ultimately hoping to improve patient safety and recovery after surgery.

Key takeaways

This study uses computers to predict how muscle relaxants affect patients.
The goal is to reduce muscle weakness after surgery and other complications.
Doctors hope to give more precise medicine doses during operations.
Your standard surgical care won't change if you participate.
The research helps improve safety and recovery for future patients.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. You must be having a type of non-heart surgery where you'll be under general anaesthesia and receive a muscle relaxing medicine called rocuronium. The hospital also needs to be using special monitors that measure how your muscles are recovering after the relaxant.

There aren't many reasons why you might not be able to join, as long as you meet the main criteria. Essentially, if you're an adult having a common type of surgery with general anaesthesia and muscle relaxants, and your hospital has the right monitoring equipment, you might be eligible.

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 surgery that's not on your heart?
Will you have general anaesthesia for your surgery?
Will you be given a muscle relaxant called rocuronium?
Will your hospital be using muscle monitors during your operation?

Answer every question to see your result.

What does participation involve?

If you take part in this study, it won't involve any extra appointments or changes to your surgery plan. The study will mainly use information that is already collected during your operation, such as your medical details, the medicines you receive, and the readings from the muscle monitoring equipment. The only additional step is that before your surgery, the anaesthetist will make an estimate, just like the computer program, of when your muscles will recover. Your actual recovery time will be carefully measured during your surgery. You will not need to take any extra medication or do anything differently; the study just observes what happens during your standard care. The total duration of your involvement would be the length of your surgery.

Potential risks and benefits

There are no direct benefits to you as an individual for taking part in this study, as it's observing current practice without changing your care. However, your participation will help researchers create better tools for future patients, potentially leading to safer anaesthesia and fewer complications. This study involves minimal risk, as it uses information already collected during your standard surgery and doesn't change your treatment. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (2)

University Hospital Ulm
Verified postcode
Ulm, Germany
Technical University Munich
Verified postcode
Munich, Germany

Common questions

What is 'residual paralysis'?

It's when your muscles still feel a bit weak or floppy after surgery because the muscle relaxant medicine hasn't fully worn off yet.

What are muscle relaxants?

These are medicines given during general anaesthesia to temporarily stop muscle movement, making surgery easier for the doctors.

What is AI or machine learning?

It's like teaching a computer program to learn from lots of information to make smart predictions, in this case, about how medicines work.

Will my surgery be different if I join?

No, your surgery and medical care will be exactly the same. The study just gathers information from your routine care.

Will this study help me directly?

Not directly, as it's a research project for future improvements. But your involvement will contribute to better safety and care for other patients down the line.