Not yet recruitingInterventional

Pilot study of a smart in tracheal tube designed to monitor breathing and body functions (iTraXS 1)

This study is testing a new type of breathing tube, called iTraXS, which is used during surgery when patients are under a general anaesthetic. This special tube has tiny fibre optic sensors that can measure things like oxygen levels and blood flow inside the airway. Doctors want to see if these sensors can help them monitor patients better and make sure the tube is in the correct place. The study involves up to 40 adults aged 18 to 70 who are already having surgery that requires a breathing tube. They will receive the new iTraXS tube instead of a standard one. Researchers will check if the sensors work well, if healthcare staff find it easy to use, and if it could lead to safer monitoring for patients undergoing surgery in the future.

At a glance

Status

Not yet recruiting

Sponsor

University of Nottingham

Enrolment target

Start

01 Aug 2026

Estimated completion

01 May 2027

Surgery

What is this study about?

When you have an operation under general anaesthetic, a tube is often placed in your windpipe to help you breathe. It's really important that this tube is in exactly the right place and that the gentle balloon at its end (called a cuff) has the correct pressure. If it's not quite right, there can be problems, like low oxygen or even harm to the airway.

Currently, doctors rely on other monitors, but these don't directly tell them what's happening inside the breathing tube itself. The iTraXS tube is a brand-new design that has very tiny sensors built into it. These sensors are like miniature cameras that can measure important things such as oxygen levels and blood flow inside your airway. They can also help confirm that the tube is in the perfect position.

This study is the very first time the iTraXS tube is being tested in people having surgery. The main goals are to see if these new sensors work as expected, if they can accurately confirm the tube's position, and if doctors and nurses find it easy to use. The researchers also want to make sure they can find enough people to take part in this study to plan for a bigger study later on. Ultimately, this research aims to make breathing tubes and monitoring during surgery even safer for everyone.

Key takeaways

This study tests a new 'smart' breathing tube during surgery.
The iTraXS tube has sensors to monitor important body functions.
It aims to improve safety and monitoring during operations.
Participants will receive standard NHS care, with minor changes to equipment.
There are no direct benefits to participants, but it could help future patients.
The study takes place at Queen's Medical Centre in Nottingham.

Who may be eligible?

This study is looking for up to 40 adults between the ages of 18 and 70. To be considered, you must already be scheduled for an operation that will require both a breathing tube and a thin tube (an 'arterial line') to be placed in an artery, usually in your wrist, as part of your standard care.

There are some important reasons why you might not be able to join the study for your safety. For example, if your doctors expect it might be difficult to place a breathing tube, or if you've had certain surgeries around your throat or food pipe before. People with certain severe reflux conditions, a history of swallowing difficulties, or who are pregnant also cannot take part.

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 between 18 and 70 years old?
Are you having planned surgery that needs a breathing tube and an arterial line?
Are you able to understand and sign a consent form?
Do you have any conditions that make breathing tube placement difficult?
Do you have severe acid reflux or swallowing problems?
Are you currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your care will be exactly as planned for your operation. The main differences are that your usual breathing tube will be swapped for the new iTraXS tube. For a short time, a second iTraXS tube will be gently placed in your food pipe (which is next to your windpipe) to get some comparison readings. You won't feel this once you're asleep. During the operation, the sensors in the tubes will collect information.

Also, a few extra blood samples will be taken, but these will be drawn from the arterial line that's already in place for your surgery, so you won't need any additional needle pokes. All collected information will be kept safe and anonymous. Your involvement ends the day after your surgery when you will be reviewed by the study team.

Potential risks and benefits

You won't directly benefit from taking part in this study, but the findings could help improve the safety of breathing tubes and monitoring during surgery for future patients. The risks associated with the iTraXS tube are generally similar to those of a standard breathing tube, such as a possible sore throat or a hoarse voice afterwards. There's a very small chance of irritation or injury to your airway. Taking the extra blood samples carries minimal risk because they are taken from a line already used for your surgery. If there's any difficulty placing the iTraXS tube, your anaesthetist will immediately switch to a standard breathing tube, as your safety and usual NHS care are always the top priority. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Nottingham University Hospitals NHS Trust
City only
Nottingham, England

Common questions

What is iTraXS?

iTraXS is a new breathing tube with tiny sensors built-in to monitor things like oxygen levels and blood flow during surgery.

Why is this study being done?

It's the first time the iTraXS tube is being tested in patients to see if its sensors work well and if it can make surgery safer.

Will I get special treatment if I join?

No, you will receive your usual NHS care for your surgery. The only difference is the type of breathing tube used and some extra measurements.

What happens after the surgery?

You will be reviewed the day after your operation, and your involvement in the study will then finish.

Who is funding this study?

The study is funded by the Medical Research Council in the UK.

How to find out more

Harriet Howard

harriet.howard5@nhs.net - Official trial record

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