RecruitingNAINTERVENTIONAL

Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure

This study, called PNEUMA, is a first look (preliminary safety and feasibility trial) at a new way to help patients with serious breathing problems (acute hypoxemic respiratory failure) who are on a breathing machine (mechanical ventilation). Normally, these patients get a lot of medicine to fully relax their muscles. However, full muscle relaxation can cause problems. This study explores using a smaller, more controlled amount of muscle-relaxing medicine (cisatracurium) to allow for some gentle, natural breathing effort while the breathing machine does its job. The goal is to see if this approach is safe and practical, helping to protect the lungs and improve patient comfort over a 48-hour period. It applies to adults over 18.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Oct 2020

Estimated completion

01 Mar 2027

Respiratory Insufficiency Neuromuscular Blockade Mechanical Ventilation

What is this study about?

When people are very poorly and have serious breathing issues, they sometimes need a breathing machine, also known as a ventilator. In many cases, patients on a ventilator are given strong medicines to completely relax their breathing muscles. This is often done to stop them from fighting against the machine, which can be harmful to their lungs.

However, completely relaxing all the breathing muscles can also come with its own set of problems. This study is looking into a new idea: instead of full muscle relaxation, could using just a little bit of muscle-relaxing medicine (called cisatracurium) allow patients to make some gentle, safe breathing efforts on their own? The researchers hope this 'partial' relaxation might be safer and better for the lungs, while still ensuring the ventilator can do its job effectively.

The main aim of this study is to check if this partial muscle relaxation approach is safe for patients and if it can actually work in practice. The team will carefully adjust the medicine to find the right balance, allowing patients to breathe gently and comfortably, while monitoring them closely for 48 hours to see if these conditions can be maintained.

Key takeaways

This study explores a new way to help seriously ill patients breathe on a ventilator.
It uses a muscle-relaxing medicine (cisatracurium) to allow gentle, partial breathing.
The main goal is to check if this method is safe and practical.
Participants will be closely monitored for up to 48 hours.
It's for adults 18+ with significant breathing problems on a breathing machine.

Who may be eligible?

This study is open to adults aged 18 and over who have moderate to severe breathing problems and are currently on a breathing machine (ventilator). This includes patients who might also be receiving a special type of life support called venovenous-ECMO.

There are certain reasons why someone might not be able to join. You wouldn't be able to take part if you have an allergy to muscle-relaxing medications or a history of a rare condition called malignant hyperthermia. Also, if you have nerve damage in both arms or burns on both wrists, which would prevent doctors from monitoring nerve signals, you wouldn't be able to participate. Finally, if you've been diagnosed with a nerve or muscle condition in the past, you would not 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 currently on a breathing machine because of serious breathing problems?
Do you have any known allergies to muscle-relaxing medicines?
Have you been diagnosed with a nerve or muscle condition before?
Do you have severe nerve damage in both arms or burns on both wrists?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, doctors will adjust your existing sedation medicines to ensure you are comfortable. Then, an infusion of a muscle-relaxing medicine called cisatracurium will be started. This medicine will be carefully adjusted to allow for some gentle, natural breathing efforts. The medical team will closely monitor your breathing, comfort, and muscle activity using special tests. Once the right balance is found, this pattern of medication will be maintained for up to 48 hours, or until your breathing improves significantly. Throughout this time, your doctors and nurses will be looking after you very closely.

Potential risks and benefits

The potential benefits of this study include exploring a new way to protect your lungs and potentially improve your comfort while on a breathing machine. However, like all medical treatments, there are potential risks, such as unexpected reactions to the study medication or difficulty in finding the right balance of medication. The research team will monitor you very closely for any issues. Remember, your participation is completely voluntary, and you can choose to stop taking part in the study at any time, for any reason, without affecting your regular medical care.

Locations (1)

University Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'breathing machine'?

A breathing machine, also known as a ventilator, is a medical device that helps you breathe when your lungs are too weak or sick to do it on their own.

What is cisatracurium?

Cisatracurium is a medicine that helps relax your muscles. In this study, it's used in a controlled way to allow for some gentle breathing while you're on a breathing machine.

How long will I be involved in the study?

The main part of the study involves receiving the special medication for up to 48 hours, or until your breathing problems get much better.

Can I stop participating if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason. Your decision will not affect your medical care.

Will I be fully awake during the study?

The study aims to ensure you have adequate sedation, meaning you will be comfortable and not fully aware while the medication is being adjusted and monitored.

How to find out more

Glauco M. Plens, MD, PhD

glauco.plens@uhn.ca 4373299590 Official trial record

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