Not yet recruitingOBSERVATIONAL

Tracheostomy Practice in Adult Intensive Care Units

This international study, called ON TRACH, is observing how tracheostomies are performed and cared for in intensive care units (ICUs) globally. A tracheostomy is a procedure where a small opening is made in the neck to help a patient breathe, often when they need a breathing machine for a long time. The study will track how and when tracheostomies are inserted, how patients are looked after, and their progress over time. By observing many different ICUs, researchers hope to understand why there are differences in care. This information will then be used to make sure patients with tracheostomies receive the best and safest care possible in the future.

At a glance

Status

Not yet recruiting

Sponsor

Royal College of Surgeons, Ireland

Enrolment target

2,500

Start

02 Nov 2026

Estimated completion

01 Mar 2029

Tracheostomy Patients Tracheostomy Decannulation Intensive Care (ICU)

What is this study about?

When people are very unwell in intensive care, some need help breathing for a longer period. A common way to do this is with a tracheostomy, which is a small tube placed in the windpipe through the neck to help them breathe more easily or to use a breathing machine. This is a very important part of critical care, and about one in five patients in intensive care units (ICUs) will have this procedure.

Even though tracheostomies are common, there are many different ways they are performed and managed across hospitals and countries. Doctors and nurses want to understand these differences better. This study will carefully observe current practices in many ICUs around the world. It will look at things like when the tracheostomy is done, how it's put in, how patients are cared for afterward, and how they recover. It will also look at how hospitals are set up to support these patients.

The main goal is to identify why these differences in care exist. By understanding this, doctors can work towards improving the way tracheostomies are performed and managed, making sure care is consistent, safer, and leads to better recovery for all patients in the future. The study hopes to gather information from many patients to get a clear picture of what's happening globally.

Key takeaways

This study is observing how tracheostomies are used in ICUs globally.
It aims to improve care and safety for patients with breathing tubes.
No changes will be made to your medical treatment if you participate.
The study helps identify best practices for tracheostomy care.
Participation involves sharing information about your existing care.

Who may be eligible?

To be part of this study, you would need to be an adult, 18 years or older, who has a tracheostomy tube inserted while you are an inpatient in an intensive care unit (ICU).

However, some people would not be included. This means you wouldn't be able to join if you had your tracheostomy before you were admitted to the ICU. You also wouldn't be included if your tracheostomy was planned in advance for a specific head or neck condition, or if it was an emergency procedure to clear your airway. Lastly, if you only had a very small, temporary tube called a 'mini tracheostomy', you would not be eligible for this study.

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?
Did you have a tracheostomy inserted while you were in intensive care (ICU)?
Did you NOT have your tracheostomy before you were admitted to the ICU?
Was your tracheostomy NOT planned specifically for a head or neck condition?
Was your tracheostomy NOT just a very small, temporary tube?
Was your tracheostomy NOT an emergency procedure to clear your airway?

Answer every question to see your result.

What does participation involve?

This study is an 'observational' one, which means researchers will simply collect information about your care as it happens anyway. You won't be asked to do anything extra or different from your usual medical care. There are no special visits, assessments, or medications involved. Researchers will gather details about when your tracheostomy was inserted, how it's managed, and your recovery journey while you're in the ICU. They will also look at your progress after you leave the ICU, if that information is available. The total duration of data collection for each patient depends on their stay in the ICU and how long they have a tracheostomy, but it will fit within the hospital's normal follow-up procedures.

Potential risks and benefits

Because this is an observational study, it means no changes are made to your care; researchers are just watching and collecting information about what usually happens. This means there are no direct new risks to you from taking part. The main benefit is that the information gathered from your experience, along with many others, will help doctors and nurses understand how to improve care and safety for future patients who need a tracheostomy. You are always free to decide if you want your information to be included or not, and you can change your mind at any time without it affecting your medical care.

Locations (13)

Beth Israel Medical Centre
Verified postcode
Boston, United States
University of Michigan Health Ann Arbor
Verified postcode
Ann Arbor, United States
Nereu Ramos Hospital
Verified postcode
Florianópolis, Brazil
Toronto General Hospital
Verified postcode
Toronto, Canada
Tata Memorial Hospital
Verified postcode
Mumbai, India
Beaumont Hospital
Verified postcode
Dublin, Ireland
Mater Misericordiae University Hospital Dublin
Verified postcode
Dublin, Ireland
Galway University Hospital
Verified postcode
Galway, Ireland
Ospedale Policlinico San Martino Genoa
Verified postcode
Genova, Italy
University of Naples Frederico II
Verified postcode
Naples, Italy
University Hospital San Luigi Gonzaga Turin
Verified postcode
Torino, Italy
University Hospital of Lausanne
Verified postcode
Lausanne, Switzerland

Common questions

What is a tracheostomy?

A tracheostomy is a small opening made in the neck with a tube inserted into the windpipe to help a person breathe, often when they need support from a breathing machine.

Why is this study being done?

The study aims to understand how tracheostomies are currently used and managed in ICUs worldwide. By seeing what's happening, doctors can find ways to make care safer and better for patients.

Will my treatment change if I join this study?

No, your medical care and treatment will not change. This study simply observes and collects information about the care you would receive anyway.

Who is paying for this study?

The information provided does not specify the funding source, but typically clinical studies are funded by medical research organisations, governments, or universities.

Can I choose not to be in the study?

Yes, taking part is completely voluntary. You can decide not to participate, or you can withdraw at any time, and this will not affect your medical care.

How to find out more

Aisling Mc Mahon, MB BCh BAO FCAI FJFICMI

aislingmcmahon@mater.ie +35318032204 Official trial record

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